Big Pharma’s Next Move: BMS, Merck, Amgen Eye M&A to Tackle Patent Expirations

Top drugmakers face a wave of patent expirations, pressuring them to acquire new products for near-term launches. A recent report highlights the looming loss of exclusivity (LOE) for major pharma firms between 2025-2030 and 2030-2040. BMS, Merck, Amgen, Novartis, and AstraZeneca face significant risks while companies like Eli Lilly and Novo Nordisk also have future exposure. To mitigate risks, these firms are focusing on strategic acquisitions, partnerships, and innovations. Patent losses on blockbuster drugs like Eliquis, Keytruda, and Eylea are set to reshape the competitive landscape. In response, firms are scrambling to acquire new assets and strengthen their pipelines for long-term growth. Those facing greater risks from generic competition may also look to early-stage candidates beyond their current portfolios.

Bristol Myers Squibb, Merck, Amgen, Novartis, and AstraZeneca Bracing for Major Generic and Biosimilar Competition

Generic and biosimilar versions of drugs are having a significant impact on the pharmaceutical market. When the patent for Lipitor (atorvastatin) from Pfizer expired, generic versions entered the market, offering the same benefits at lower costs. Similarly, after Viagra (sildenafil) by Pfizer lost its patent, generic versions of the drug became available. Biosimilars also present competition. After Humira (adalimumab) from AbbVie lost its exclusivity, biosimilars like Amjevita (from Amgen) and Hulio (from Sandoz) emerged. Likewise, Rituxan (rituximab) from Genentech faces biosimilars such as Truxima (from Celltrion) and Ruxience (from Pfizer). These developments demonstrate how patent expirations allow generics and biosimilars to compete, lowering drug prices and impacting branded companies.

In a report by Leerink Partners, analysts focused on 17 large pharmaceutical companies with drugs generating over $1 billion in revenue by 2025 or 2030. They excluded antibody-drug conjugates, CAR-T therapies, vaccines, and gene therapies from their projections due to the absence of generics or biosimilars for these drug types. The report acknowledges that patent extensions or litigation could delay LOEs for certain drugs. Furthermore, companies must pursue both internal R&D and external acquisitions to stay competitive. The main takeaway is clear: firms facing major LOE risks from 2025-2030 must acquire assets with near-term launch potential. Meanwhile, companies with LOE risks beyond 2030 may focus on acquiring earlier-stage assets to build stronger future pipelines.

Bristol Myers Squibb, Merck, Amgen, Novartis, and AstraZeneca will face significant competition from generics and biosimilars by 2030. Vertex, Gilead, Sanofi, Novo Nordisk, and Eli Lilly will experience less exposure during this period. From 2030, companies like Lilly, Gilead, Novo Nordisk, Regeneron, and Biogen will face increased patent expirations, while Vertex, GSK, Pfizer, Takeda, and Amgen will be better positioned.

BMS and Merck Face Significant Patent Expirations, Fueling Need for Strategic Acquisitions

According to the Leerink’s report, BMS faces the greatest risk of exposure to generics and patent losses. The company could see 64% of its estimated $48.3 billion revenue in 2025 impacted by LOEs through the decade’s end. BMS’ Eliquis (apixaban), a blood thinner used to prevent stroke and blood clots, is most at risk, with generics set to enter the U.S. market in 2028. Opdivo (nivolumab), an immunotherapy for cancer, and Pomylast (pomalidomide), a treatment for multiple myeloma, are also on the verge of losing U.S. exclusivity by 2028 and 2026, respectively.

In response, BMS is prioritizing licensing partnerships and earlier-stage acquisitions. CEO Chris Boerner emphasized the company’s “financial discipline,” which provides flexibility for both internal and external innovation investments. Recently, BMS’ $14 billion acquisition of Karuna Therapeutics led to FDA approval for Cobenfy (lumateperone), a breakthrough schizophrenia treatment. Following BMS, Merck is next in line for significant LOE exposure, with 47% of its $72 billion 2025 revenue at risk. Keytruda (pembrolizumab), an immunotherapy used for various cancers, faces U.S. LOE by 2028. Merck also anticipates patent losses for Januvia (sitagliptin), a diabetes drug, Bridion (sugammadex), a muscle relaxant reversal agent, and Lynparza (olaparib), a treatment for ovarian and breast cancers, in the coming years. Despite these challenges, Merck has significant cash reserves and plans to pursue assets at various stages of clinical development.

Merck and Amgen Target Strategic Acquisitions to Strengthen Pipelines in Key Therapeutic and Rare Disease Areas

Merck faces significant exposure from LOEs on drugs like Januvia (sitagliptin), a diabetes treatment, Bridion (sugammadex), a muscle relaxant reversal agent, and Lynparza (olaparib), an ovarian cancer treatment. These patents are set to expire between 2026 and 2027. Despite this, Merck has ample cash reserves and plans to pursue acquisitions, focusing on assets ranging from $1 billion to $15 billion. CEO Robert Davis emphasized the company’s capacity to handle deals of any size, while continuing to prioritize acquisitions within this range. Merck also noted its growing pipeline, having tripled the number of Phase 3 assets over the past three years. Davis highlighted that Merck is actively seeking candidates across all therapeutic areas to strengthen its pipeline.

Amgen faces a similar challenge, with 42% of its 2025 revenue at risk from LOEs on drugs like Prolia (denosumab), a bone density drug, Enbrel (etanercept), used for autoimmune diseases, Xgeva (denosumab), a cancer-related bone drug, and Repatha (evolocumab), a cholesterol-lowering treatment. The company has already settled with Sandoz to allow biosimilars of Prolia and Xgeva to launch in May 2025. Despite these challenges, Amgen remains optimistic after its $27.8 billion acquisition of Horizon Therapeutics, a rare disease drugmaker. R&D head Jay Bradner stated that Amgen expects a mix of internal and external innovation to replenish its rare disease pipeline in the coming years.

Novartis Faces 37% LOE Risk on Projected $52 Billion 2025 Revenue; AstraZeneca’s $58 Billion Revenue Faces 35% LOE Exposure

Looking to Novartis, the company faces significant LOE exposure, with 37% of its projected $52 billion revenue in 2025 at risk through 2030, according to Leerink. Its heart failure treatment, Entresto, is vulnerable to generics, with patent challenges in both the U.S. and Europe. Entresto, which treats heart failure and chronic kidney disease, could see competition as early as next year. Additionally, Cosentyx, used for arthritis and plaque psoriasis, is expected to lose U.S. exclusivity in 2028. Currently, Bio-Thera Solutions is conducting a Phase 3 trial for a biosimilar version of Cosentyx, aiming for approval in both Europe and the U.S.

Moreover, during Novartis’ third-quarter earnings call, CEO Vas Narasimhan outlined the company’s focus on bispecifics and cell therapies for future development. He also noted that while Novartis has ample capital for deals, the company has concentrated on acquisitions in the sub-$1-billion range. Narasimhan explained that these deals are strategic, aimed at filling key therapeutic and technological gaps in the company’s pipeline.

Similarly, AstraZeneca, with an expected $58 billion in 2025 revenue, also faces substantial LOE risks, with 35% of its revenue exposed to generics and patent expirations. The company’s diabetes, heart failure, and chronic kidney disease drug, Farxiga, is at the highest risk, accounting for 14% of projected revenue. Furthermore, drugs like Lynparza (used in oncology), Soliris (for rare diseases like paroxysmal nocturnal hemoglobinuria), and Symbicort (for asthma and chronic obstructive pulmonary disease) are all scheduled to lose patent protection in the next five years. AstraZeneca’s strategic focus on oncology and cell therapies was evident in its $1 billion acquisition of CAR-T developer Gracell Biotechnologies last year.

Regeneron Faces the Biggest Patent Threat, With 74% of Revenue at Risk from Eylea and Dupixent

While companies like BMS, Merck, Amgen, Novartis, and AstraZeneca must closely monitor generics in the coming years, firms like Vertex, Gilead, Sanofi, Novo Nordisk, and Eli Lilly should also remain vigilant. Despite strong current sales, Novo Nordisk and Eli Lilly face significant LOE exposure between 2030 and 2040, with 65% and 71% of their projected revenue at risk. This is mainly due to potential patent expirations for key drugs like Mounjaro, Zepbound, Ozempic, and Wegovy. Meanwhile, Novartis, AstraZeneca, and Merck will encounter substantial intellectual property challenges post-2030. Notably, Regeneron faces the greatest immediate threat, with 74% of its revenue at risk due to upcoming patent losses for blockbuster drugs like Eylea and Dupixent.

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