Patent expiry and generic competition

“Large pharmaceutical companies and generics manufacturers of pharmaceutical products continue to expand into the biotechnology field and form partnerships to pursue biosimilars. Companies have developed and are developing biosimilars that compete with AbbVie’s biologic products. As competitors obtain marketing approval for biosimilars referencing AbbVie’s biologic products, AbbVie’s products may become subject to competition from such biosimilars, with the attendant competitive pressure and consequences.”

Annual report 2025A · The company itself

“Net revenues for Humira decreased 49% in 2025 primarily driven by continued impact of direct biosimilar competition following the loss of exclusivity.”

Annual report 2025A · The company itself

“A significant portion of AbbVie's revenues and operating earnings are derived from two major products. Specifically, Skyrizi and Rinvoq each represented greater than 10% of AbbVie's total net revenues and, in aggregate, these products accounted for approximately 42% of total net revenues in 2025.”

Annual report 2025A · The company itself

“Driven by cost pressures, efforts to limit or weaken patent protection for our industry are increasing. For example, the COVID-19 pandemic resulted in increased interest in compulsory licenses, march-in rights or other governmental interventions, both in the United States and internationally, related to the procurement of drugs, and governments and international bodies have since adopted or considered regulations that could facilitate the use of such measures during public health or other emergencies. At the end of 2023, the prior Administration released a proposed framework that would consider price as a factor when determining whether to exercise march-in rights pursuant to the Bayh-Dole Act with respect to drugs or other taxpayer-funded inventions, and the status and potential implementation of such framework remains uncertain.”

Annual report 2025A · The company itself

“Third parties have challenged and may continue to challenge, invalidate or circumvent our patents (including any patent applications, term extensions, term adjustments and supplemental protection certificates) relating to our products, product candidates and technologies. See Part IV—Note 20, Contingencies and commitments, to the Consolidated Financial Statements.”

Annual report 2025A · The company itself

“Further, under the Hatch–Waxman Act, our products approved by the FDA under the FDCA have been, and may in the future be, the subject of patent litigation with generics competitors before expiry of the five-year period of data exclusivity provided for under the Hatch-Waxman Act and prior to the expiration of the patents listed for the product. Likewise, our innovative biologic products have been, and may in the future be, the subject of patent litigation prior to the expiration of our patents and, with respect to competitors seeking approval as a biosimilar or interchangeable version of our products, prior to the 12-year exclusivity period provided under the BPCIA.”

Annual report 2025A · The company itself

“We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future. We currently face competition from biosimilars and generics in most of the territories in which we operate, including the United States and Europe, and we expect to face increasing biosimilar and/or generics competition this year and beyond.”

Annual report 2025A · The company itself

“In the United States, the FDA has approved numerous biosimilars, including biosimilar versions of Neulasta, EPOGEN, ENBREL, Prolia and XGEVA, and a growing number of companies have announced that they are also developing biosimilar versions of our products. For example, a number of biosimilar versions of Prolia and/or XGEVA have been approved in the United States and EU, and impact to our Prolia and XGEVA sales are expected to accelerate as the number of additional competitors continues to increase.”

Annual report 2025A · The company itself

“Under the U.S. biosimilar regulatory framework, certain biosimilars have been approved as interchangeable with their reference products, which can allow pharmacists, subject to state law, to substitute those biosimilars for our products without prior prescriber approval and could increase competitive pressure on our products.”

Annual report 2025A · The company itself

“Upon the expiration or loss of patent protection and/or applicable exclusivity for one of our products, we can lose the majority of revenues for that product in a very short period of time.”

Annual report 2025A · The company itself

“While we are unable to predict the precise effects and timing of biosimilars and generics on our products, we are currently facing and expect to face greater competition in the United States, Europe and elsewhere as a result of biosimilar and generic competition and, in turn, downward pressure on our product prices and sales. This competition has had, and could increasingly have, a material adverse effect on our product sales, business and results of operations.”

Annual report 2025A · The company itself

“See We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future. Delays or uncertainties in the development or implementation of such pathways, or changes in existing regulatory pathways, including degradation of regulatory standards, could result in delays or difficulties in getting our biosimilar products approved by regulatory authorities, subject us to unanticipated development costs or otherwise reduce the value of the investments we have made in the biosimilars area.”

Annual report 2025A · The company itself

“IP risks related to our products The pharmaceutical industry is experiencing pressure from governments and other payers to impose limits on IP protections to manage healthcare costs. If we are unable to obtain, defend and enforce our IP, we may experience accelerated and intensified competition.”

Annual report 2025A · The company itself

“Brilinta sales decreased by 38% (CER: 38%) driven by generic entry in the US and Europe in the first half of 2025.”

Annual report 2025A · The company itself

“Our products continue to face increasing competition from the introduction of new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways. Some of these products are likely to be sold at substantially lower prices than our branded products. The introduction of such products as well as other lower-priced competing products has in the past reduced, and may in the future significantly reduce, both the price that we are able to charge for our products and the volume of products we sell, which has and may continue to negatively impact our revenue.”

Annual report 2025A · The company itself

“Our success, including our long-term viability and growth, depends, in part, on our ability to obtain and defend patent and other intellectual property rights, including certain regulatory forms of exclusivity, that are important to the commercialization of our products and product candidates.”

Annual report 2025A · The company itself

“In many markets, including the U.S., manufacturers may be allowed to rely on the safety and efficacy data of the innovator's product and do not need to conduct clinical trials before marketing a competing version of a product after there is no longer patent or regulatory exclusivity. In such cases, manufacturers often charge significantly lower prices and a major portion of the company's revenue may be reduced in a short period of time.”

Annual report 2025A · The company itself

“BioInvents framtida framgångar beror i stor utsträckning på bolagets förmåga att erhålla och bibehålla patentskydd för potentiella produkter och i viss utsträckning för de egna teknologierna. Bolagets patentärenden hänför sig till såväl företagets kärnteknologi inom utveckling av antikroppsläkemedel och olika aspekter på denna som olika antikroppsprodukter under utveckling och deras användning som läkemedel.”

Annual report 2024A · The company itself

“In the pharmaceutical industry, the majority of an innovative product’s commercial value is usually realized during the period in which the product has market exclusivity. A product’s market exclusivity is generally determined by two forms of intellectual property: patent rights held by the innovator company and any regulatory forms of exclusivity to which the innovative drug is entitled.”

Annual report 2025A · The company itself

“When these patent rights and other forms of exclusivity expire and generic versions of a medicine are approved and marketed, there are often substantial and rapid declines in the sales of the original innovative product.”

Annual report 2025A · The company itself

“The increased likelihood of generic and biosimilar challenges to innovators’ intellectual property has increased the risk of loss of innovators’ market exclusivity. First, generic companies have increasingly sought to challenge innovators’ patents covering major pharmaceutical products.”

Annual report 2025A · The company itself

“The length of market exclusivity for any of our products is impossible to predict with certainty because of the complex interaction between patent and regulatory forms of exclusivity and the inherent uncertainties regarding patent litigation. There can be no assurance that a particular product will enjoy market exclusivity for the full period of time that appears in the estimate or that the exclusivity will be limited to the estimate.”

Annual report 2025A · The company itself

“(e) For Eliquis, in the U.S., multiple generic companies challenged patents listed in the FDA Orange Book. BMS, along with its partner Pfizer, settled with a number of these generic companies and won at the trial and appellate levels against others. Under the terms of previously executed settlement agreements, the generic companies with whom BMS settled are permitted to launch in 2028, subject to additional challenges.”

Annual report 2025A · The company itself

“In the EU, the apixaban composition of matter patents and related SPCs expire in November 2026. Generics have challenged the composition of matter patents and related SPCs in various jurisdictions and trials have taken place, or are scheduled to take place, in certain European countries. While these legal proceedings are pending, generic manufacturers have begun marketing generic versions of Eliquis in certain EU countries and may seek to market generic versions of Eliquis in other EU countries prior to the expiration date of apixaban patents and related SPCs.”

Annual report 2025A · The company itself

“(j) For Pomalyst in the U.S., generic entry is expected in the first quarter of 2026.”

Annual report 2025A · The company itself

“(l) For Revlimid, in the U.S., certain generic companies have begun marketing generic lenalidomide products pursuant to volume-limited licenses granted as part of litigation settlements. As of January 31, 2026, the licenses are no longer volume-limited.”

Annual report 2025A · The company itself

“In the EU and Japan, generics have entered the market.”

Annual report 2025A · The company itself

“(n) For Sprycel, in the U.S., EU and Japan, generics have entered the market.”

Annual report 2025A · The company itself

“Another competitive challenge we face is from generic pharmaceutical manufacturers. In certain countries, including the U.S. and in the EU, the regulatory approval process exempts generics from costly and time-consuming clinical studies to demonstrate their safety and efficacy, allowing generic manufacturers to rely on the safety and efficacy of the innovator product. As a result, generic pharmaceutical manufacturers typically invest far less in R&D than research-based pharmaceutical companies and therefore can price their products significantly lower than branded products. Accordingly, when a branded product loses its market exclusivity, it normally faces intense price competition from generic forms of the product.”

Annual report 2025A · The company itself

“After the expiration of exclusivity, the rate of revenue decline of a product varies by country. In general, the decline in the U.S. market is more rapid than in most other developed countries, though we have observed rapid declines in a number of EU countries as well.”

Annual report 2025A · The company itself

“In certain countries outside the U.S., patent protection is weak or nonexistent and we are challenged by generic versions shortly after we launch our innovative products.”

Annual report 2025A · The company itself

“We could lose market exclusivity of a product earlier than expected. In the pharmaceutical and biotechnology industries, the majority of an innovative product’s commercial value is realized during its market exclusivity period. In the U.S. and in some other countries, when market exclusivity expires and generic versions are approved and marketed or when biosimilars are introduced (even if only for a competing product), there are usually very substantial and rapid declines in a product’s revenues.”

Annual report 2025A · The company itself

“Generic and biosimilar product manufacturers as well as other groups seeking financial gain are also increasingly seeking to challenge patents before they expire, and we have faced and may continue to face earlier-than-expected competition for any products at any time. Patents covering our key products have been, and are likely to continue to be, subject to validity, enforceability and infringement challenges in patent litigations and post-grant review patent office proceedings.”

Annual report 2025A · The company itself

“Lower-priced generics or biosimilars for BMS biologics or competing biologics could negatively impact our volumes and prices.”

Annual report 2025A · The company itself

“A reduction in revenue from any of these products due to loss of market exclusivity or other factors could adversely impact our earnings and cash flows.”

Annual report 2025A · The company itself

“Our pretax income could be adversely affected as the royalty streams decline in future periods. For example, (i) royalties related to Keytruda* are expected to terminate on December 31, 2026, (ii) royalties related to Tecentriq* are expected to terminate on December 31, 2026, and (iii) royalties related to the divestiture of our diabetes business terminated on December 31, 2025.”

Annual report 2025A · The company itself

“Patent och andra immateriella rättigheter Camurus har en aktiv immaterialrättsstrategi, där bolaget strävar efter att skydda sina plattformsteknologier och produkter på viktiga världsmarknader. Det föreligger en risk att befintliga och framtida patent, varumärken och övriga immateriella rättigheter som innehas av Camurus inte kommer att utgöra ett fullgott kommersiellt skydd mot intrång och konkurrens.”

Annual report 2024A · The company itself

“Use of Generic and Biosimilar Pharmaceuticals. A number of patents for widely used brand-name pharmaceutical products will continue to expire during the next several years. In addition, increased emphasis by managed care and other third-party payors on utilization of generics and biosimilars has accelerated their growth. We consider the increase in generic and biosimilar usage a favorable trend because generic and biosimilar pharmaceuticals have historically provided us with a greater gross profit margin opportunity than brand-name products, although their lower prices reduce revenue growth.”

Annual report 2025A · The company itself

“We have introduced strategies to enhance our position in the generic marketplace, including our generic product private label program based in Ireland. We source generics globally, offer a value-added generic formulary program to our healthcare provider customers, and monitor our customers’ compliance with our generics program.”

Annual report 2025A · The company itself

“Corteva currently faces significant competition in the markets in which it operates. In most segments of the market, the number of products available to the grower is steadily increasing as new products are introduced. At the same time, certain products are coming off patent and are thus available to generic manufacturers for production and commercialization.”

Annual report 2025A · The company itself

“Förutsättningarna för att patentskydda medicinska och medicintekniska uppfinningar är generellt sett svårbedömda och omfattar komplexa juridiska och tekniska frågor. Det finns en risk att Egetis Therapeutics utvecklar produkter som inte kan patenteras, att ingivna patentansökningar inte kommer att leda till beviljade patent eller beviljas med begränsat skyddsomfång, att beviljade patent inte kommer att kunna vidmakthållas eller att beviljade patent inte kommer att utgöra tillräckligt skydd för Egetis Therapeutics produkter.”

Annual report 2024A · The company itself

“Det finns en risk att Egetis Therapeutics utvecklar produkter som inte kan patenteras, att ingivna patentansökningar inte kommer att leda till beviljade patent eller beviljas med begränsat skyddsomfång, att beviljade patent inte kommer att kunna vidmakthållas eller att beviljade patent inte kommer att utgöra tillräckligt skydd för Egetis Therapeutics produkter. Vidare kan invändningar eller andra ogiltighetsanspråk mot patent som beviljats Egetis Therapeutics komma att göras eſter godkännande av patenten.”

Annual report 2024A · The company itself

“Innovationer inom life science härstammar ofta från små biotechbolag. Eftersom de globala läkemedels- 1) Adderar man livsstilsfaktorer till ekvationen står bolagen står inför stora patentutgångar som kommer vi inför en stadig ökning av människor som lever med att leda till minskade intäkter, behöver de fylla på sina kroniska tillstånd som kardiovaskulära sjukdomar, cancer, pipelines med projekt från mindre biotechbolag som kroniska luftvägssjukdomar och diabetes.”

Annual report 2024A · The company itself

“Djup förståelse för sektorn Optimering av kapitalets hävstångseffekt Läkemedelsutveckling är en utdragen process på mellan 5–15 år där kostnaderna ökar för varje fas i utvecklingen. Otillräckligt med kapital innebär en risk för lovande projekt, förseningar minskar patenttiden efter godkännande vilket i sin tur påverkar intäktsflödet för produkten.”

Annual report 2024A · The company itself

“Under de kommande fem åren förväntas 23 PKI-patent för läkemedelssubstanser löpa ut, vilket skapar en betydande marknadsmöjlighet för bolaget.”

Annual report 2024A · The company itself

“The impact of DARZALEX patent expirations will have an adverse impact on Genmab’s future royalty revenue.”

Annual report 2025A · The company itself

“We also face significant competition from: (i) large pharmaceutical and biotechnology companies and specialized pharmaceutical firms acting either independently or together with other such companies to pursue the development of products and technologies that may be competitive with our existing products or research programs; (ii) academic institutions, government agencies and other public and private organizations conducting research who may seek patent protection or may establish collaborative arrangements for competitive products or programs; (iii) pricing pressures from private insurers and government payers as our products mature, which often result in a reduction of our net product prices; and (iv) new branded or generic products introduced into major markets, which may impact our ability to maintain pricing and market share.”

Annual report 2025A · The company itself

“Patents and Proprietary Rights U.S. and EU Patent Expiration We have a number of U.S. and foreign patents, patent applications and rights to patents related to our compounds, products and technology. The following table shows the estimated expiration dates (including patent term extensions, supplementary protection certificates and/or pediatric exclusivity where granted) in the U.S. and the European Union (“EU”) for the primary (typically compound) patents for our key product candidates as described above.”

Annual report 2025A · The company itself

“(6) In October 2025, Gilead entered into settlement agreements to resolve patent litigations with Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd., generic manufacturers that filed abbreviated new drug applications with FDA to market generic versions of Biktarvy. Under the agreements, which are subject to standard acceleration provisions, no generic entry is expected prior to April 1, 2036 in the U.S. for Biktarvy tablets containing bictegravir (50 mg), FTC (200 mg) and TAF (25 mg).”

Annual report 2025A · The company itself

“We may be unable to sustain or increase sales of our HIV products for any number of reasons, including market share gains by competitive products, including generics, or the inability to introduce new HIV medications necessary to remain competitive.”

Annual report 2025A · The company itself

“In addition, certain countries do not provide effective mechanisms for enforcement of our patents, and third-party manufacturers may be able to sell generic versions of our products in those countries.”

Annual report 2025A · The company itself

“Future litigation or other proceedings regarding the enforcement or validity of our existing patents or any future patents could result in the invalidation of our patents or substantially reduce their protection.”

Annual report 2025A · The company itself

“We have entered into agreements with generic drug manufacturers as well as licensing agreements with the Medicines Patent Pool, a United Nations-backed public health organization, which allow generic drug manufacturers to manufacture generic versions of certain of our products for distribution in certain low- and middle-income countries.”

Annual report 2025A · The company itself

“Generic competition in Canada, starting in the second quarter of 2025 led to continued erosion in the second half of the year”

Annual report 2025A · The company itself

“Generic competition in Canada, starting in the second quarter of 2025 led to continued erosion in the second half of the year.”

Annual report 2025A · The company itself

“This performance is mainly impacted by the continued generic erosion, particularly in Japan, Canada and Italy, partially offset by demand growth in a few other markets.”

Annual report 2025A · The company itself

“Overall, Lundbeck’s 2026 guidance underscores the company’s ability to navigate increasing generic pressure – primarily driven by Abilify Maintena ® – while sustaining growth and profitability and continuing to invest for long-term value creation, reinforcing its position as a focused innovator in neuroscience.”

Annual report 2025A · The company itself

“•If we are unable to achieve milestones, develop product candidates to license or renew or enter into new collaborations, our royalty and milestone revenues and future prospects for those revenues may decrease. •Any arbitration or litigation involving us and regarding intellectual property infringement claims could be costly and disrupt our drug discovery and development efforts. •Our inability to adequately protect or enforce our proprietary information may result in loss of revenues or otherwise reduce our ability to compete. •If the effective term of our patents is decreased or if we need to refile some of our patent applications, the value of our patent portfolio and the revenues we derive from it may be decreased. •International patent protection is particularly uncertain and costly, and our involvement in opposition proceedings may result in the expenditure of substantial sums and management resources.”

Annual report 2025A · The company itself

“Our products compete, and our product candidates may in the future compete, with currently existing therapies, including generic drugs, product candidates currently under development by us and others, or future product candidates, including new chemical entities that may be safer or more effective or more convenient than our products. Any products that we develop may be commercialized in competitive markets, and our competitors, which include large global pharmaceutical and biopharmaceutical companies and smaller research-based biotechnology companies, may succeed in developing products that render our products obsolete or noncompetitive.”

Annual report 2025A · The company itself

“The Hatch-Waxman Act provides significant incentives to generic manufacturers to challenge U.S. patents on successful innovative pharmaceutical products. We have received a notice letter from each of Apotex, Inc., Hikma Pharmaceuticals USA Inc., Sun Pharmaceutical Industries Inc., Granules India Ltd., Dr. Reddy’s Laboratories, Inc., and Eugia Pharma Specialties, Ltd., which we refer to as the Generic Manufacturers, notifying us that each has filed an ANDA requesting approval to market a generic version of JAKAFI that contains a paragraph IV certification purporting to challenge one or more patents covering ruxolitinib composition of matter and its use that expire (with pediatric extension) in June 2028 and patents covering ruxolitinib phosphate and its use that expire (with pediatric extension) in December 2028.”

Annual report 2025A · The company itself

“We have received a notice letter from each of Padagis Israel Pharmaceuticals Ltd., Taro Pharmaceuticals Inc., Zydus Lifesciences Limited and Encube Ethicals Private Limited notifying us that each has filed an ANDA requesting approval to market a generic version of OPZELURA and that contains a paragraph IV certification purporting to challenge one or more patents covering ruxolitinib phosphate cream and its uses that expire in 2031 and 2040.”

Annual report 2025A · The company itself

“The entry of a competitive drug product from another company or a generic version of one of our products could result in a decrease in sales of our products and materially harm our business, operating results, and financial condition.”

Annual report 2025A · The company itself

“In addition, revenues from JAKAFI currently make up the substantial majority of our total revenues, but we expect that revenues from JAKAFI will begin to decline once patent exclusivity expires in 2028. We cannot assure you that we will be able to generate revenues from our other marketed drug products to offset the expected decline in revenues from JAKAFI.”

Annual report 2025A · The company itself

“The technology that we use to make and develop our drug products, the technology that we incorporate in our products, and the products we are developing may be subject to claims that they infringe the patents or proprietary rights of others. We are aware of patents and patent applications filed in certain countries claiming intellectual property relating to some of our drug discovery targets and drug candidates. While the validity of issued patents, patentability of pending patent applications and applicability of any of them to our programs are uncertain, if any of these patents are asserted against us or if we choose to license any of these patents, our ability to commercialize our products could be harmed or the potential return to us from any product that may be successfully commercialized could be diminished.”

Annual report 2025A · The company itself

“In addition, our patents may be challenged and invalidated or may fail to provide us with any competitive advantages if, for example, others were first to invent or first to file a patent application for the technologies and products covered by our patents. As noted above under “Risks Relating to Commercialization of Our Products—Competition for our products could harm our business and result in a decrease in our revenue,” potential generic drug company competitors have challenged certain patents relating to JAKAFI and OPZELURA.”

Annual report 2025A · The company itself

“Successful challenges to our patent or other intellectual property rights through these proceedings could result in a loss of rights in the relevant jurisdiction and allow third parties to use our proprietary technologies without a license from us or our collaborators, which may also result in loss of future royalty payments.”

Annual report 2025A · The company itself

“Bolagets immateriella rättigheter skyddas främst genom patent och patentansökningar. Det finns risk att IRLAB:s patentansökningar inte beviljas och/eller att beviljade patent angrips av tredje part och/ eller att tredje part avsiktligt eller oavsiktligt gör intrång i patenten, varumärken och andra immateriella rättigheter.”

Annual report 2024A · The company itself

“Kliniska läkemedelskandidaten pirepemat Pirepemats främsta konkurrensfördelar • ”First in class”-behandling med unik verkningsmekanism för balansnedsättning och minskad risk för fall vid Parkinson. • God tolerabilitet. • Utvecklas mot en ny marknad med mycket stort kliniskt behov och begränsad konkurrens – i dagsläget inga. • Starkt patentskydd: globala patent och patentansökningar kan ge exklusivitet in i 2040-talet.”

Annual report 2024A · The company itself

“Två nya patent beviljades under det gångna året I september 2024, beviljades IRLAB ytterligare patent som expanderar patentskyddet för mesdopetam i Europa och för pirepemat i USA. De beviljade patenten utökar de redan starka patentskydden för dessa läkemedelskandidater, vilket är positivt för projektens värde.”

Annual report 2024A · The company itself

“Starkt IP-skydd IRLAB arbetar kontinuerligt med att patentskydda bolagets teknologier och innovationer. Detta sker genom ett kontinuerligt arbete i processer med syfte att skydda de immateriella rättigheterna för ISP-plattformen och företagets läkemedelskandidater.”

Annual report 2024A · The company itself

“Sales of the Company’s largest product, collectively DARZALEX (daratumumab) and DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), accounted for approximately 15.0% of the Company's total revenues for fiscal 2025.”

Annual report 2025A · The company itself

“Third parties have filed biologics license applications with the U.S. FDA, the European Medicines Agency, and other government authorities seeking approval to market biosimilar versions of STELARA around the globe. The Company expects continued launches of biosimilar versions of STELARA globally which will continue to negatively impact the Company’s sales of STELARA.”

Annual report 2025A · The company itself

“For the Company’s Innovative Medicine businesses, loss of patent exclusivity for a product often is followed by a substantial reduction in sales as competitors gain regulatory approval for generic, biosimilar and other competing products and enter the market.”

Annual report 2025A · The company itself

“For those products in our portfolio that rely on patent protection, once a patent has expired, the product is generally open to competition. Products under patent protection usually generate significantly higher revenues than those not protected by 15 patents.”

Annual report 2025A · The company itself

“When new products, uses, or delivery systems with therapeutic, convenience, or cost advantages are introduced, including by developing new modalities, our existing products become subject to decreased sales volumes, progressive price reductions, or both.”

Annual report 2025A · The company itself

“Generic Pharmaceuticals and Biosimilars Generic pharmaceuticals and biosimilars can pose major competitive challenges to our business. In most major jurisdictions, the regulatory approval process for pharmaceuticals (other than biological products (biologics)) exempts generics from costly and time-consuming clinical trials to demonstrate their safety and efficacy, allowing generic manufacturers to rely on the safety and efficacy of the innovator product. As a result, generic manufacturers generally invest far fewer resources in research and development than we do for our branded products and can price their products significantly lower than branded products. Accordingly, when a branded non-biologic pharmaceutical loses its market exclusivity, it normally faces intense price competition from generic forms of the product, which can result in the loss of a significant portion of the branded product's revenue in a very short period of time.”

Annual report 2025A · The company itself

“In addition, competition for our biologics, which constitute a substantial portion of our products and pipeline, may be affected by the approval of follow-on biologics, also known as biosimilars. A biosimilar is a subsequent version of an approved innovator biologic that, due to its analytical and clinical similarity to the innovator biologic, may be approved based on an abbreviated data package that relies in part on the full testing required of the innovator biologic.”

Annual report 2025A · The company itself

“Patents, Trademarks, and Other Intellectual Property Rights Overview Intellectual property protection is critical to our ability to successfully commercialize our life sciences innovations and invest in the search for new medicines and uses. Loss of effective patent protection for pharmaceuticals can result in the loss of effective market exclusivity for the product, often leading to a severe and rapid decline in revenues for the product.”

Annual report 2025A · The company itself

“•Patent term extension for a single patent for a pharmaceutical product is provided to U.S. patent holders to compensate for a portion of the time invested in clinical trials and the FDA review process. There is a five-year cap on any restoration, and no patent's expiration date may be extended beyond 14 years from initial FDA approval.”

Annual report 2025A · The company itself

“The primary forms of data protection are as follows: •Data package protection generally prohibits regulatory approval of other manufacturers' applications for marketing approval if they rely on the innovator company's regulatory submission data for the drug. The base period is generally five years in the U.S. (12 years for new biologics under the BPCIA, subject to certain conditions), effectively 10 years in Europe, and eight years in Japan, which can be extended to 10 years with qualifying pediatric studies.”

Annual report 2025A · The company itself

“•In the U.S., the FDA has the authority to grant additional data protection for approved drugs where the sponsor conducts specified testing in pediatric populations within a specified time period. If granted, this "pediatric exclusivity" provides an additional six months of exclusivity, which is added to the end of any other unexpired exclusivity and, for products other than biologics, to the end of certain unexpired patents. •A specific use of a drug or biologic can receive "orphan" designation in the U.S. if it is intended to treat a disease or condition affecting fewer than 200,000 people in the U.S., or where it is not reasonably expected to recover development and marketing costs through U.S. sales.”

Annual report 2025A · The company itself

“Outside the major markets, the adequacy and effectiveness of intellectual property protection for pharmaceuticals vary widely. International and U.S. free trade agreements like the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement) administered by the World Trade Organization provide global protection of certain intellectual property rights. But in a number of markets we are unable to patent our products or to enforce the patents that we receive for our products. Further, many developing countries, and some developed countries, do not provide effective data package protection even though it is specified in the TRIPs Agreement.”

Annual report 2025A · The company itself

“Patent Challenges In the U.S., the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, authorizes the FDA to approve generic versions of innovative pharmaceuticals (other than biologics) when the generic manufacturer files an Abbreviated New Drug Application (ANDA). Absent a patent challenge, the FDA cannot approve an ANDA until after certain of the innovator's patents expire. However, after the innovator has marketed its product for four years, a generic manufacturer may file an ANDA alleging that the patent(s) listed in the innovator's New Drug Application (NDA) are invalid, unenforceable, or not infringed.”

Annual report 2025A · The company itself

“Generic manufacturers use this process extensively to challenge patents on innovative pharmaceuticals. In addition, generic companies have shown willingness to launch "at risk" (i.e., after receiving ANDA approval) but before final resolution of their patent challenge.”

Annual report 2025A · The company itself

“Under the BPCIA, the FDA cannot approve an application for a biosimilar product until data protection expires, 12 years after initial marketing approval of the innovator biologic, and an application may not be submitted until four years following the date the innovator biologic was first approved. However, the BPCIA does provide a mechanism for a prospective biosimilar competitor to challenge the validity of an innovator's patents as early as four years after initial marketing approval of the innovator biologic. The patent litigation scheme under the BPCIA, and the BPCIA itself, is complex and continues to be interpreted and implemented by the FDA, as well as by courts.”

Annual report 2025A · The company itself

“In addition, there is a procedure in U.S. patent law, known as inter partes review (IPR), which allows any member of the public to file a petition with the USPTO seeking the review of any issued U.S. patent for validity. IPRs are conducted before Administrative Patent Judges in the USPTO using a lower standard of proof than used in federal district court and challenged patents are not accorded the presumption of validity. Generic drug companies and even some investment firms have engaged in the IPR process in attempts to invalidate our patents.”

Annual report 2025A · The company itself

“New product candidates that appear promising in development or prior to being acquired may fail to reach the market or may have only limited commercial success because of efficacy or safety concerns, inability to obtain or maintain necessary regulatory approvals or payer reimbursement or coverage, failure to obtain placement on guidelines or recommendations published by third-party organizations, the application of pricing controls, limited scope of approved uses, label changes, changes in the relevant treatment standards or the availability of newer, better, or more cost-effective competitive products, difficulty or excessive costs to manufacture, insufficient infrastructure to support detection, diagnostic or other requisites for treatment, ineffectiveness in connecting with healthcare professionals, including digitally through virtual engagements, or infringement of the patents or intellectual property rights of others.”

Annual report 2025A · The company itself

“Through internal innovation and business development we must maintain a flow of successful products and indications or line extensions sufficient both to cover our substantial research and development costs and investments and to replace revenues that are lost as profitable products become subject to pricing controls, lose intellectual property exclusivity, are displaced by competing products, or therapies, or experience a reduction in patient access. Failure to replenish our product portfolio and pipeline in a timely manner would have a material adverse effect on our business, results of operations, cash flows, and financial position.”

Annual report 2025A · The company itself

“Our product revenues and prospects are adversely affected by patient access issues, the introduction by competitors of branded products that are first to market, have better marketplace access, have greater brand recognition, or are perceived as superior by the marketplace, by price competition, by generic or biosimilar versions of our branded products, and by generic or biosimilar versions of other products in the same therapeutic class as our branded products.”

Annual report 2025A · The company itself

“In the ordinary course of their lifecycles, our products lose significant patent protection and/or data protection after a specified period of time. For example, Trulicity will lose significant patent and remaining data protections in the next few years.”

Annual report 2025A · The company itself

“We have faced, and remain exposed to, generic or biosimilar competition following the expiration or loss of such intellectual property protection. Patent expirations of competitive products may also shift market conditions for our products by contracting the market for branded products, impacting product access, or otherwise intensifying pricing pressures across similar treatments.”

Annual report 2025A · The company itself

“For non-biologic products, loss of exclusivity typically results in the entry of one or more generic competitors, leading to a rapid and severe decline in revenues, especially in the U.S.”

Annual report 2025A · The company itself

“Changes proposed by the USPTO and by certain bills in Congress to limit the number of, and differences between, patents obtained could also affect the scope of patent protection for our products in the U.S.”

Annual report 2025A · The company itself

“We face many generic manufacturer challenges to our patents outside the U.S. as well. The entry of generic competitors typically results in rapid and severe declines in revenues.”

Annual report 2025A · The company itself

“Den starka resultattillväxten 2023 som till stor del drevs av försäljningsutvecklingen av Melatonin på den brittiska marknaden, förbyttes mot en kraftig resultatminskning 2024 när konkurrensen tilltog och priserna sänktes för produkten.”

Annual report 2024A · The company itself

“Den starka resultattillväxten 2023 som till stor del drevs av utlicensieringen av Melatonin till den brittiska marknaden, förbyttes mot en kraftig resultatminskning 2024 när konkurrensen tilltog och priserna sänktes för produkten.”

Annual report 2024A · The company itself

“Specialistläkemedel hade ett väsentligt mer utmanande år.”

Annual report 2024A · The company itself

“The Company’s operations may be adversely affected by generic and biosimilar competition as the Company’s products mature, as well as technological advances of competitors, industry consolidation, patents granted to competitors, competitive combination products, new products of competitors, the availability of generic or biosimilar versions of competitors’ branded products, and new information from clinical trials of marketed products or post-marketing surveillance.”

Annual report 2025A · The company itself

“In addition, patent rights are increasingly being challenged by competitors, and the outcome can be highly uncertain. An adverse result in a patent dispute can preclude commercialization of products or negatively affect sales of existing products and could result in the payment of royalties or in the recognition of an impairment charge with respect to intangible assets associated with certain products.”

Annual report 2025A · The company itself

“The highly competitive animal health business is affected by several factors including regulatory and legislative issues, scientific and technological advances, product innovation, the quality and price of the Company’s products as well as competitors’ products, effective promotional efforts and the frequent introduction of generic products by competitors.”

Annual report 2025A · The company itself

“Patents, Trademarks and Licenses Patent protection is considered, in the aggregate, to be of material importance to the Company’s marketing of its products in the U.S. and in most major foreign markets.”

Annual report 2025A · The company itself

“Patent portfolios developed for products introduced by the Company normally provide varying degrees of market exclusivity. Key patents, which generally cover the product per se, may be subject to a patent term restoration (also known as patent term extension or PTE) of up to five years in the U.S., Japan, and certain other jurisdictions. In Europe, up to five years of extended term may be available in the form of a Supplementary Protection Certificate (SPC).”

Annual report 2025A · The company itself

“While the expiration of the compound patent generally results in loss of market exclusivity for the covered pharmaceutical product, other patents may provide additional market exclusivity associated with certain aspects of the product that extends beyond the compound patent expiration, including those derived from the initial discovery of the product’s active ingredient(s) or from product-related innovation that occurs after this initial discovery. These include later-expiring patents directed to (i) processes and intermediates related to methods of manufacture of the active ingredient(s), (ii) use(s) of the product, and (iii) novel compositions and formulations of the product.”

Annual report 2025A · The company itself

“The following is a summary of the principal risk factors facing the Company: Table of Contents •The Company is dependent on its patent rights, and if its patent rights are invalidated or circumvented, its business could be materially adversely affected. •As the Company’s products lose market exclusivity, the Company generally experiences a significant and rapid loss of sales from those products. •Key products generate a significant amount of the Company’s profits and cash flows, and any events that adversely affect the markets for its leading products could have a material adverse effect on the Company’s results of operations, cash flows, financial condition, and prospects.”

Annual report 2025A · The company itself

“As the Company’s products lose market exclusivity, the Company generally experiences a significant and rapid loss of sales from those products. The Company depends upon patents to provide it with exclusive marketing rights for its products for some period of time. Loss of patent protection for one of the Company’s products typically leads to a significant and rapid loss of sales for that product as lower priced generic or biosimilar versions become available.”

Annual report 2025A · The company itself

“Bridion will lose market exclusivity in the U.S. in July 2026 at which time the Company anticipates a significant and rapid decline in U.S. sales of Bridion. The Company expects to discontinue U.S. sales of Bridion by the end of 2026.”

Annual report 2025A · The company itself

“In addition, Januvia and Janumet will lose market exclusivity in the U.S. in May 2026 and Janumet XR will lose market exclusivity in the U.S. in July 2026. The Company expects a significant decline in sales of Januvia in the first half of 2026 reflecting the impact of government price setting noted above and subsequently, following loss of market exclusivity in May 2026, the Company anticipates it will lose nearly all U.S. sales of Januvia and Janumet.”

Annual report 2025A · The company itself

“Also, the Company expects that sales of Keytruda will be materially negatively impacted by biosimilar competition between 2028 and 2029. As previously disclosed, while two patents in the Keytruda composition of matter patent family expire in May and November of 2029, respectively, the Company expects these patents to be the subject of litigation and, thus, biosimilar competition could begin in December 2028 when the primary compound patent expires.”

Annual report 2025A · The company itself

“Other events could include loss of patent protection, selection for IRA price setting, lower than expected utilization of Keytruda Qlex, increased costs associated with manufacturing, generic, biosimilar or over-the-counter availability of the Company’s product or a competitive product, the discovery of previously unknown side effects, results of post-approval trials, increased competition from the introduction of new, more effective treatments and discontinuation or removal from the market of the product for any reason.”

Annual report 2025A · The company itself

“Although it is not possible to predict or identify all such factors, they may include the following: •Competition from generic and/or biosimilar products as the Company’s products lose patent protection.”

Annual report 2025A · The company itself

“As previously disclosed, beginning in 2019, a number of generic drug companies filed ANDAs seeking approval of generic forms of Januvia and Janumet along with Paragraph IV certifications challenging the validity of the salt/polymorph patent. The Company has settled with over two dozen generic companies providing that these generic companies can bring their generic versions of Januvia and Janumet to the market in the U.S. in May 2026 or 114 Table of Contents earlier under certain circumstances, and their generic versions of Janumet XR to the market in July 2026 or earlier under certain circumstances.”

Annual report 2025A · The company itself

“Januvia, Janumet, Janumet XR — As previously disclosed, the FDA granted pediatric exclusivity with respect to Januvia (sitagliptin), Janumet (sitagliptin/metformin HCl), and Janumet XR (sitagliptin and metformin HCl extended-release), which provides a further six months of exclusivity in the U.S. beyond the expiration of all patents listed in the FDA’s Orange Book. Adding this exclusivity to the term of the key patent protection extended exclusivity on these products to January 2023.”

Annual report 2025A · The company itself

“Eisai has announced publicly, these generic companies can bring their generic versions of Lenvima to the market in the U.S. in July 2030 or earlier under certain circumstances.”

Annual report 2025A · The company itself

“Patent Litigation From time to time, generic and biosimilar manufacturers of pharmaceutical products file abbreviated New Drug Applications (ANDAs) and Biologics License Applications, respectively, with the FDA seeking to market generic and biosimilar forms of the Company’s products prior to the expiration of relevant patents owned by the Company. To protect its patent rights, the Company may file patent infringement lawsuits against such generic and biosimilar companies.”

Annual report 2025A · The company itself

“Risker förknippade med bolagets verksamhet Immaterialrättsligt skydd I den typ av verksamhet som Moberg Pharma bedriver föreligger alltid risken att bolagets patent, varumärken eller övriga immateriella rättigheter inte ger tillräckligt skydd för bolaget, att ansökningar inte beviljas eller att bolagets rättigheter inte kan vidmakthållas. Vidare kan intrång i patent eller varumärken komma att ske, vilket kan leda till kostsamma tvister.”

Annual report 2024A · The company itself

“Det finns en risk att utestående patentansökningar eller dataexklusivitet inte kommer att beviljas eller att kopior av Bolagets produkter börjar säljas på närliggande marknader där Bolagets produkt inte har beviljats patent. Framtida patentutgångar, upphörande av dataexklusivitet och inträde av generiska produkter på marknaden kan påverka Bolagets försäljning negativt. Skulle kopior av Bolagets produkter börja säljas på samma marknader som Bolagets produkter, eller kunder vända sig till närliggande marknader med alternativa, billigare produkter, så finns det en risk att Bolagets förväntade försäljning minskar.”

Annual report 2024A · The company itself

“Moberg Pharma förlitar sig till viss del på opatenterade företagshemligheter, know-how och fortsatt teknologisk innovation för att utveckla och behålla sin position på marknaden. Om bolaget inte skulle vara framgångsrikt i att skydda dessa företagshemligheter, know-how och teknologi finns det en risk att bolagets marknadsposition skulle kunna komma att påverkas negativt samt att värdet av bolagets kommersialiserade produkter, teknologier och produktkandidater skulle påverkas negativt.”

Annual report 2024A · The company itself

“Flera patent inom insulin- och insulinanalogområdet har nyligen gått ut och ett antal patent går ut under kommande år. Detsamma gäller för GLP-1-analoger där exempelvis patentskyddet för semaglutid går ut i Kina 2026. Detta driver på en utveckling av biosimilarer.”

Annual report 2024A · The company itself

“the loss of exclusivity for the semaglutide molecule in certain markets in International Operations”

Annual report 2025A · The company itself

“The impending loss of exclusivity for semaglutide actually strengthens this approach. Generic competition will help establish an affordable foundation whilst we build differentiated innovations on top of that.”

Annual report 2025A · The company itself

“As semaglutide nears loss of exclusivity in certain key markets, we are acting decisively, launching second brands in lower‑priced segments, fast‑tracking differentiated devices and sharpening our channel strategies, while reinforcing quality and pharmacovigilance as generics enter the market.”

Annual report 2025A · The company itself

“Novo Nordisk is exposed to portfolio dependency with multiple brands relying on semaglutide as the active pharmaceutical ingredient.”

Annual report 2025A · The company itself

“The success of the Company will highly depend on the Company’s ability to obtain and maintain patent protection for its products, methods, processes and other technologies, to preserve trade secrets, to prevent third parties from infringing proprietary rights of the Company and to operate without infringing the proprietary rights of third parties. To date, the Company holds certain exclusive patent rights in major markets. The patent rights are limited in time.”

Annual report 2024A · The company itself

“Patenttvisten med Sun Pharmaceutical Industries (Sun) avseende Zubsolv ® i USA nådde en lösning, vilket gör det möjligt för Sun att lansera generika på Zubsolv på den amerikanska marknaden i september 2030.”

Annual report 2024A · The company itself

“Zubsolvs volym visade den mest stabila utvecklingen sedan förlusten av den exklusiva positionen hos försäkringsbolagen United Health Group (UHG) och Humana under 2019, med minus 2 procent (–5).”

Annual report 2024A · The company itself

“Patenttvisten löstes för Zubsolv i USA För Zubsolv ® i USA löstes en långvarig patenttvist med Sun Pharmaceutical Industries (Sun), vilket gör det möjligt för Sun att komma in på marknaden med sitt generika i september 2030. Överenskommelsen eliminerade risken för Sun att vinna i överklagandedomstolen, vilket skulle kunna ha möjliggjort marknadsinträde för generika på Zubsolv redan 2025.”

Annual report 2024A · The company itself

“Immateriella rättigheter Att erhålla och upprätthålla patent och andra immateriella rättigheter som skyddar teknik och produkter är en väsentlig del för att kunna öka och bibehålla intäktsströmmar och skapa långsiktigt värde för aktieägare. Orexo har en intern patentavdelning som arbetar i nära samarbete med innovatörer och utvecklingsteam samt med externa rådgivare för att säkerställa att alla aspekter av den innovativa utvecklingsprocessen täcks in, vilket lägger grunden för patentportföljen.”

Annual report 2024A · The company itself

“Patentstrategin innebär att ha rätt skydd på plats på de relevanta marknaderna för en viss produkt. Produktspecifika patent är viktiga tillgångar, oavsett om företaget väljer att sälja en produkt via en kommersiell partner eller ta den till marknaden med hjälp av det egna kommersiella teamet.”

Annual report 2024A · The company itself

“Zubsolv är patentskyddat i EU till och med 2032.”

Annual report 2024A · The company itself

“För Abstral löpte de flesta av de återstående patenten som täcker produkterna i RoW-regionen 6 ut 2024, liksom vissa kommersialiseringsavtal.”

Annual report 2024A · The company itself

“Under flera dagar i december var handeln i aktien som högst, vilket kan hänföras till att bolaget meddelade en lösning i patenttvisten med Sun Pharmaceuticals avseende Zubsolv ® i USA.”

Annual report 2024A · The company itself

“Minskningen under angiven period beror dels på lägre volymutveckling efter att Zubsolvs exklusiva position upphörde när generika lades till på försäkrings bolagen Humana och United Health Groups läkemedelslistor 2019.”

Annual report 2024A · The company itself

“Certain of our products have experienced patent-based expirations or loss of regulatory exclusivity in certain markets in the last few years, and we expect certain products to face new or increased generic competition over the next few years. We anticipate a significant reduction of revenue from patent-based or regulatory exclusivity expiries in 2026 through 2030 as several of our in-line products experience these expirations, with the rate of the reduction of revenues from patent-based or regulatory exclusivity expiries expected to significantly accelerate over the next few years.”

Annual report 2025A · The company itself

“The loss, expiration or invalidation of intellectual property rights, patent litigation settlements and judgments and the expiration of co-promotion and licensing rights can have a material adverse effect on our revenues. Once patent protection has expired or has been lost prior to the expiration date as a result of a legal challenge, we typically lose market exclusivity on these products, and generic and biosimilar pharmaceutical manufacturers generally produce identical or highly similar products and sell them for a lower price. The date at which generic or biosimilar competition commences may be different from the date that the patent or regulatory exclusivity expires. However, when generic or biosimilar competition does commence, the resulting price competition can substantially decrease our revenues for the impacted products, often in a very short period of time.”

Annual report 2025A · The company itself

“Generic Products. Generic pharmaceutical manufacturers pose one of the biggest competitive challenges to our branded small molecule products because they can market a competing version of our product after the expiration or loss of our patent protection, or exclusivity, and often charge much less. Several competitors regularly challenge our product patents before their expiration. Generic competitors often operate without large R&D expenses, as well as without costs of conveying medical information about products to the medical community.”

Annual report 2025A · The company itself

“Our vaccines have and may continue to face competition, including from the introduction of alternative vaccines or “next-generation” vaccines prior to or after the expiration of their patents, which may adversely affect our future results.”

Annual report 2025A · The company itself

“In addition, our patented products may face generic or biosimilar competition before patent-based and/or regulatory exclusivity expires, including from “at-risk” launch (despite pending patent infringement litigation against the generic or biosimilar product) by a manufacturer of a generic or biosimilar version of one of our patented products. Generic and biosimilar manufacturers have filed or could file applications with the FDA seeking approval of product candidates that they claim do not infringe our or our collaboration and licensing partners’ patents or claim that our or our collaboration and licensing partners’ patents are not valid.”

Annual report 2025A · The company itself

“We may become subject to competition from biosimilars referencing our biologic products if competitors are able to obtain marketing approval for such biosimilars.”

Annual report 2025A · The company itself

“If these products or any of our other major products were to, or continue to (if applicable), experience loss of patent protection (if applicable), changes in prescription or vaccination purchasing or growth rates, reduced product demand, material product liability litigation, unexpected side effects or safety concerns, regulatory proceedings or investigations, lower governmental and/or regulatory confidence, negative publicity affecting doctor or patient confidence, pressure from competitive products, changes in recommendations and coverage, changes in labeling, pricing and access pressures, including those related to the IRA and MFN, or supply shortages or if a new, more effective product should be introduced, the adverse impact on our revenues could be significant and our revenue forecasts and expectations could prove to be inaccurate and we may fail to meet these expectations.”

Annual report 2025A · The company itself

“Claims against our patents include challenges to the coverage and/or validity of our patents on various products or processes. There can be no assurance as to the outcome of these matters, and a loss in any of these cases could result in a loss of patent protection for the product at issue, which could lead to a significant loss of sales of that product and could materially affect future results of operations.”

Annual report 2025A · The company itself

“If we fail to obtain and maintain adequate intellectual property protection, we may not be able to prevent third parties from launching generic or biosimilar versions of our branded products, from using our proprietary technologies or from marketing products that are very similar or identical to ours.”

Annual report 2025A · The company itself

“The scope of our patent claims also may vary between countries, as individual countries have distinct patent laws, and our ability to enforce our patents depends on the laws of each country, its enforcement practices, and the extent to which certain countries engage in policies or practices that weaken a country’s intellectual property framework (e.g., laws or regulations that promote or provide broad discretion to issue a compulsory license).”

Annual report 2025A · The company itself

“In countries that provide some form of regulatory exclusivity, mechanisms exist permitting some form of challenge to our patents by competitors or generic drug marketers prior to or immediately following the expiration of such regulatory exclusivity, and generic companies are employing aggressive strategies, such as “at-risk” launches that challenge our patent rights. Most of the suits involve claims by generic drug manufacturers that patents covering our products, uses, processes or dosage forms are invalid and/or do not cover the product of the generic or biosimilar drug manufacturer.”

Annual report 2025A · The company itself

“Also, if one of our patents or a competitors’ patents is found to be invalid in such proceedings, generic or biosimilar products could be introduced into the market resulting in the erosion of sales of our existing products.”

Annual report 2025A · The company itself

“Once we have final regulatory approval of the related products, we may decide to commercially market these products even though associated legal proceedings (including any appeals) have not been resolved (i.e., “at-risk” launch). If one of our marketed products (or a product of our collaboration/licensing partners to which we have licenses or co-promotion rights) is found to infringe valid patent rights of a third party, such third party may be awarded significant damages or royalty payments, or we may be prevented from further sales of that product.”

Annual report 2025A · The company itself

“Potential expansion of our mRNA portfolio could result in an increase in patent-related disputes as well.”

Annual report 2025A · The company itself

“Amortization of Intangible Assets Amortization of intangible assets decreased $413 million, primarily due to lower amortization related to Prevnar, fully amortized assets and asset impairments.”

Annual report 2025A · The company itself

“In addition to these programs, we continuously monitor our operations for cost reduction and/or productivity opportunities, especially in light of patent-based and regulatory exclusivity expiries as well as the expiration of collaborative arrangements for various products.”

Annual report 2025A · The company itself

“We own or have co-promotion and/or license rights related to a number of patents covering pharmaceutical and other products, their uses, formulations, and product manufacturing processes. Patents for individual products extend for varying periods according to the date of patent filing or grant and the legal term of patents in the various countries where patent protection is obtained. The scope of protection afforded by a patent can vary from country to country and depends on the patent type, the scope of its patent claims and the availability of legal remedies.”

Annual report 2025A · The company itself

“However, qualified innovative biological products receive 12 years of regulatory exclusivity, meaning that the FDA may not approve a biosimilar version until 12 years after the innovative biological product was first approved by the FDA. However, the term of regulatory exclusivity may not remain at 12 years in the United States and could be shortened if, for example, the PPACA is amended.”

Annual report 2025A · The company itself

“Biosimilar versions of EYLEA have been recently approved and/or launched in the United States, EU, and other jurisdictions, with additional biosimilar versions of EYLEA and/or EYLEA HD in development, as discussed further under "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - The commercial success of our products and product candidates is subject to significant competition - Marketed Products" above. As an EYLEA biosimilar has been launched in the United States following the expiration of the U.S. regulatory exclusivity period for EYLEA (i.e., the period during which no biosimilar product could be approved by the FDA) in May 2024, EYLEA no longer has U.S. market exclusivity. Similarly, as EYLEA biosimilars have also been recently launched in certain jurisdictions outside the United States, EYLEA no longer has market exclusivity in those jurisdictions.”

Annual report 2025A · The company itself

“Table of Contents Approach to Growth and Innovation Viatris’ confidence in the delivery of its pipeline is rooted in its strong historic development programs and list of firsts, including the first FDA approvals of the generic versions of Advair Diskus® (Wixela Inhub®), Restasis®, Symbicort® (Breyna™), and Venofer®. The Company is working on many other programs, including patent-protected, innovative assets such as selatogrel and cenerimod, 505(b)(2) products such as fast-absorbing meloxicam for acute pain and low dose estrogen weekly patch for contraception, and on the potential to be first to market for its generics of Abilify Maintena®, Injectafer®, Ozempic®, and Wegovy™.”

Annual report 2025A · The company itself

“Many of our products are not protected by patent rights or have limited patent life and will soon lose patent protection. Loss of patent protection for a product typically is followed promptly with the launch of generic products.”

Annual report 2025A · The company itself

“For example, we may lose market exclusivity for Amitiza® 24 μg in Japan in June 2026.”

Annual report 2025A · The company itself

“With respect to government enforcement of state and federal laws, including antitrust laws, as well as private plaintiff litigation of antitrust claims, including so-called “pay for delay” patent settlements, large verdicts, settlements or government fines are possible, especially in the U.S. and EU. Additionally, some state legislatures have enacted, and the U.S. federal government or additional state legislatures could enact, legislation to limit patent settlements between pharmaceutical companies and deem such patent agreements as anticompetitive. These changes could impact our ability to launch generic products prior to the originator’s patent expiry.”

Annual report 2025A · The company itself

“Our ability to commercialize any branded product successfully will largely depend upon our or any partner’s or supplier’s ability to obtain, maintain and enforce intellectual property rights of sufficient scope to lawfully prevent third parties from developing and/or marketing infringing products. This will be of particular importance as we will look to accelerate our growth by building on the strength of our base business with an expanding portfolio of innovative, best-in-class, intellectual property-protected assets.”

Annual report 2025A · The company itself

“Teknologin möjliggör lansering av produktkandidater när det uppstår ett lanseringsfönster på marknaden, det vill säga under tidsperioden mellan utgångsdatum av det primära substanspatentet och utgångsdatum av relevanta sekundära patent som täcker kristallina former av läkemedlet. Även efter att ett originalläkemedels sekundära patent löper ut har Xspray Pharmas produktkandidater kvar sina profilfördelar som gynnar patienter, jämfört med generika som helt efterliknar originalläkemedlet.”

Annual report 2024A · The company itself

“Av de drygt 80 PKI:er som idag marknadsförs i USA förväntas 23 substanspatent att löpa ut före år 2030.”

Annual report 2024A · The company itself

“När det gäller läkemedel skyddar det primära patentet den aktiva substansen och de sekundära patenten skyddar andra aspekter av originalläkemedlet, till exempel kristallin struktur av den aktiva läkemedelssubstansen. Eftersom Xspray Pharma utvecklar läkemedel med amorf struktur omfattas de inte av originalläkemedels sekundärpatent som avser kristallin struktur. Produkterna kan därmed marknadsföras direkt efter att originalbolagens substanspatent går ut, vilket leder till gynnsamma förhållanden för en marknadsetablering.”

Annual report 2024A · The company itself

“De kan därmed marknadsföras parallellt med originalbolagets produkt, vilket skapar en fördelaktig konkurrenssituation för Xspray Pharmas produkter. Även efter att marknaden öppnas för generika har Xspray Pharmas produkter starka och patenterade fördelar tack vare HyNap-teknologin.”

Annual report 2024A · The company itself

“We depend on patents and regulatory data exclusivity periods to provide us with exclusive marketing rights for some of our products. Patents for individual products expire at different times based on the date of the patent filing (or sometimes the date of patent grant) and the legal term of patents in the countries where such patents are obtained. The extent of protection afforded by our patents varies from country to country and is limited by the scope of the claimed subject matter of our patents, the term of the patent and the availability and enforcement of legal remedies in the applicable country and potential legislative or regulatory changes to the underlying patent framework. As a result, we face competition from lower-priced generic alternatives to many of our products that no longer have patent protection.”

Annual report 2025A · The company itself

“For example, several companies have launched generic versions of our Rimadyl chewable and Draxxin products. In the years since the start of generic and other competition, sales of our Rimadyl chewable and Draxxin products have declined in the U.S., the largest market for these products, by 39% and 66%, respectively.”

Annual report 2025A · The company itself

“We also compete with companies that produce generic products, following our products’ loss of exclusivity in a given market. For example, Draxxin currently competes with generic products in key markets including the U.S., Europe, Canada, Mexico and Australia. Since 2021, the first year of generic competition, sales of Draxxin declined by 66% in the U.S., its largest market.”

Annual report 2025A · The company itself

“VD har ordet • • • • • • • finansiering av verksamheten utveckling av forskningsprojekten affärsutvecklingsprojekt strategisk inriktning bokslutsinformation Driva utvecklingen och kommersialiseringen av företagets substanser tillsammans med kompetenta partners MÅL OCH STRATEGI Stort medicinskt behov Affärsidé Kliniska milstolpar Begränsa kostnader genom partnerskapsavtal och användning av extern expertis VERKSAMHET Projekt budget och prognoser för verksamheten partnerskapsstrategi och partnerskapsdiskussioner • • Skydda know-how genom en aktiv patentstrategi Tasquinimod Laquinimod Naptumomab Styrelsens arbete och hur Active Biotech styrs beskrivs utförligt i avsnittet ”Bolagsstyrningsrapport” på sidorna 44-48.”

Annual report 2024A · The company itself

“Our patent leadership Aker BioMarine remains a global leader in patented technology for krill-based innovations. By the end of 2024, we held a total of 143 granted patents, including those covering harvesting technologies, production methods, and nutraceutical products.”

Annual report 2024A · The company itself

“As their product patents expire, competitors may be able to legally produce and market products similar to the products of our tenants or venture investment portfolio companies, which could have a material adverse effect on their sales and results of operations.”

Annual report 2025A · The company itself

“As of December 31, 2025, we had 1,137 active U.S. patents, 1,147 active foreign patents, and 1,070 pending global patent applications. Our active U.S. patents expire between 2026 and 2044.”

Annual report 2025A · The company itself

“If a company in which our funds are invested is unable to obtain regulatory approval for a product candidate, or a product candidate in which our funds are invested does not obtain regulatory approval, in a timely fashion or at all, including as a result of a delayed, hindered or abandoned clinical trial s, the value of our fund’s investment would be adversely impacted. • To the extent our BXLS portfolio companies’ intellectual property positions are challenged, invalidated or circumvented, the value of BXLS’s investment or BXLS’ rights in a termination event may be impaired. The success of a life sciences investment depends in part on the ability of the biopharmaceutical or medical device companies to obtain and defend patent rights and other intellectual property rights that are important to the commercialization of such products.”

Annual report 2025A · The company itself

“Our Pharmaceutical and Specialty Solutions segment’s profit margin could be adversely affected by changes in industry or market dynamics that we are not able to accurately predict. The frequency, timing, magnitude, and profit impact of generic pharmaceutical customer purchase volumes, pricing changes, customer contract renewals, generic pharmaceutical launches, and generic pharmaceutical manufacturer pricing changes, which contribute to the performance of our generic pharmaceutical program, remain uncertain.”

Annual report 2026A · The company itself

“Patent och rättigheter CellaVision bedriver en aktiv patentstrategi för att skydda investeringar i kärnteknologi genom att ansöka om patent för nya uppfinningar. Det kan dock inte garanteras att nuvarande eller framtida patentansökningar leder till patent eller att godkända patent erbjuder tillräckligt skydd mot konkurrenter.”

Annual report 2024A · The company itself

“Befintliga patent övervakas i samband med produktutveckling för att undvika oavsiktliga patentintrång. Dessutom bevakas företagets patent för att skydda dem mot intrång från andra.”

Annual report 2024A · The company itself

“Consumer demand for these products could be adversely affected by, among other things, delays in securing regulatory approvals, the emergence of competing or alternative products, including generic drugs, the emergence of new safety data for such products, the loss of patent and other intellectual property rights protection, reductions in private and government payment product subsidies or changing product marketing strategies.”

Annual report 2025A · The company itself

“•The composition of claims generally considers the types of drugs, including the mix of claims among branded and higher priced specialty drugs compared to generic or biosimilar alternatives. We manage pharmaceutical manufacturer increases in prices through programs designed to reduce drug spend, providing positive impacts on our clients, our customers and us.”

Annual report 2025A · The company itself

“Introduktion av nya produkter och teknologier kräver aktiv hantering av immateriella rättigheter för att säkra Hexagons teknologiska position.”

Annual report 2024A · The company itself

“Our generic pharmaceuticals distribution business is subject to both product availability and pricing risks.”

Annual report 2026A · The company itself

“Within the segment, sales to U.S. pharmacies and healthcare providers increased $31.6 billion primarily due to higher volumes from retail national account customers, partially offset by branded to generic drug conversions and branded pharmaceutical price decreases.”

Annual report 2026A · The company itself

“Development by other companies of new or improved products, processes, technologies, or the introduction of reprocessed products or competitive devices when our proprietary products lose their patent protection may make our existing or planned products less competitive.”

Annual report 2026A · The company itself

“There is a risk that some of the Company's products may face competition from new products as well as generic products. This risk may be reduced by having a more diversified portfolio of products as well as a broader geographical footprint, and Navamedic is continuously exploring ways to expand its portfolio and extending its geographical present.”

Annual report 2024A · The company itself

“Patentutgångar för marknadsledande immunmodulerande läkemedel kan således leda till prispress, med innebörden att bolaget behöver sänka priset på sin produkt för att få behålla subventioneringen. Detta innebär lägre intäkter och kan leda till att bolaget avstår från att introducera läkemedlet på marknaden.”

Annual report 2024A · The company itself

“Through our various subsidiaries, as of the date of this report, we own or have licensed rights to approximately 10,000 pending, allowed or granted patents and designs globally. Patents and designs have various statutory terms based on the legislation in individual jurisdictions which may be subject to change. Of our patents and designs, approximately 429 U.S. patents and designs and approximately 768 foreign patents and designs are due to expire in the next five years.”

Annual report 2026A · The company itself

“Dessutom har patent en begränsad livslängd och givet den tid som krävs för utveckling, testning och regulatorisk granskning av nya produktkandidater finns det en risk att patent som skyddar sådana produktkandidater löper ut före eller kort efter sådana produktkandidater kommersialiseras.”

Annual report 2024A · The company itself

“Immaterialrättsligt skydd Sobis verksamhet är beroende av immateriella rättigheter (IP-rättigheter) och av bolagets förmåga att skydda IP-rättigheterna mot intrång från tredje part. Det finns också en risk att Sobi gör intrång i tredje parts patenträttigheter.”

Annual report 2024A · The company itself

“Risker relaterade till patent och andra immateriella rättigheter SynAct är beroende av sin förmåga att skydda sina läkemedelskandidater och innovationer, särskilt dess primära läkemedelskandidat resomelagon, genom immateriella rättigheter, såsom patent, samt genom andra former av skydd såsom dataexklusivitet, vilket begränsar användning av data från kliniska studier och ger den som genomför studien tillfälliga exklusiva rättigheter till att använda sådan data för att ansöka om marknadsgodkännande.”

Annual report 2024A · The company itself

“Patent och andra immateriella rättigheter har en begränsad livslängd och det finns en risk att beviljade patent inte ger ett fullgott kommersiellt skydd, då invändningar eller andra ogiltighetsanspråk mot beviljade patent kan göras efter patentets beviljande. Om SynAct skulle tvingas försvara sina patenträttigheter mot en konkurrent, eller får ett patent ogiltigförklarat, kan detta medföra omfattande kostnader för koncernen.”

Annual report 2024A · The company itself

“Det kan även visa sig att andra aktörer har ansökt om patent avseende läkemedelskandidater som omfattas av SynActs patentansökningar utan bolagets kännedom, inklusive i förhållande till resomelagon som utgör koncernens enda läkemedelskandidat i klinisk fas. Det finns därför en risk att SynAct kan komma att göra, eller påstås göra, intrång i patent innehavda av tredje part.”

Annual report 2024A · The company itself

“•Changes in market conditions and practices within the life sciences industry—The expiration of key patents, the implications of precision medicine treatments, changes in the practices of prescribing physicians and patients, changes with respect to payer relationships, and the policies and preferences of healthcare professionals and healthcare organizations with respect to the sales and marketing efforts of life sciences companies could negatively impact demand for our solutions.”

Annual report 2026A · The company itself

“The introduction of new products or technologies, including the development of new processes or technologies by competitors or new information about existing products or technologies, results in increased competition for our marketed products and pricing pressure on our marketed products. For example, the number of compounds available to treat a particular disease typically increases over time and can result in slowed sales growth or reduced sales of our products in that therapeutic area.”

Annual report 2025A · The company itself

“Third-party manufacturers may be able to sell generic versions of our products in countries that do not provide effective mechanisms for enforcement of our patents or other intellectual property rights. For example, we have experienced a violation of our intellectual property rights in Russia, where a copy product that infringes our patents has been made available.”

Annual report 2025A · The company itself