Patent Expirations and Market Impact
By analyzing the AdisInsight database, pharmaceutical pipelines, market trends, and emerging developments, we identified several key drugs losing patents in 2026, which will have a major impact on the market. As these patents expire, the availability of generics and follow-on therapies will rise, making treatments more affordable and accessible while intensifying competition. Generic manufacturers are expected to introduce lower-cost alternatives, driving down prices for high-revenue drugs in areas like cardiovascular care and respiratory disorders. Increased access to generics will particularly benefit emerging markets, spurring growth and improving global health outcomes. However, branded drugmakers may experience revenue declines as generics take market share. To stay competitive, companies will likely focus on innovation, exploring new therapeutic areas, and developing next-generation treatments.
Major Patent Expiries and Market Implications (2024–2025)
The pharmaceutical industry is set to experience significant shifts in 2024 and 2025 as several blockbuster drug patents reach the end of their exclusivity. These expirations will open the door for generic and biosimilar competition, potentially increasing patient access and driving down costs, while also impacting brand revenues.
Notable Patent Expirations in 2024 include Sprycel (dasatinib) for chronic myeloid leukemia, Tysabri (natalizumab) for multiple sclerosis and Crohn’s disease, Victoza and Ozempic (liraglutide and semaglutide) for diabetes and weight management, Xarelto (rivaroxaban) for anticoagulation, Entresto (sacubitril/valsartan) for heart failure, and several others across oncology, antipsychotic, and infectious disease indications. These expirations will allow multiple generic and biosimilar entrants, reshaping competitive dynamics in their respective markets.
Major Patent Expirations in 2025 include Entresto and Xarelto continuing into the following year, along with Prolia/Xgeva (denosumab) for bone health, Perjeta (pertuzumab) for breast cancer, Actemra (tocilizumab) for autoimmune disorders, Descovy (emtricitabine/tenofovir) for HIV, Lenvima (lenvatinib) for thyroid and other cancers, and Xeljanz (tofacitinib) for rheumatoid arthritis. These expirations are expected to further expand generic and biosimilar options, driving market competition and potentially altering treatment accessibility.
Overall, the 2024–2025 patent cliff represents a pivotal period for both healthcare providers and pharmaceutical companies, highlighting the ongoing balance between innovation, market exclusivity, and patient access.
The most immediate effect of patent expiry is a steep decline in revenue for originator companies, with sales of affected drugs often falling by 80–90% within the first 12–18 months following generic entry. This rapid erosion places significant pressure on company performance and R&D investment capacity.
In contrast, patent expirations have been a major catalyst for growth in the generic drug market, which has expanded from approximately $411.6 billion globally in 2020 to an estimated $55 billion in India alone by 2025. These transitions have also delivered substantial cost savings for healthcare systems and patients by enabling access to more affordable versions of essential medicines. Overall, patent expirations represent a recurring and cyclical dynamic—creating financial headwinds for innovators while simultaneously improving global access to treatment.
2020- Globally
2025- India
Strategic Playbooks for Navigating Major Patent Expirations
Major pharmaceutical companies have substantially reshaped their strategies between 2023 and 2025 to mitigate the financial impact of major patent expirations. Industry leaders have adopted distinct approaches to protect revenue, sustain market share, and rebuild pipelines. Three prominent examples illustrate these strategic shifts:
1. AbbVie: “Next-Generation Migration” Strategy As biosimilars entered the U.S. market for Humira (adalimumab)—long the world’s highest-grossing drug—in 2023, AbbVie executed a deliberate transition toward its next-generation immunology assets, Skyrizi and Rinvoq. Tactics: The company leveraged established commercial and payer relationships to secure favorable formulary positioning for Skyrizi and Rinvoq, accelerating patient migration away from Humira. Outcome: By late 2024, combined sales of Skyrizi and Rinvoq were on track to surpass Humira’s peak revenue, effectively offsetting the approximately 60% decline in Humira sales recorded between 2022 and 2024.
2. Merck & Co.: “Subcutaneous Switch” Strategy With its flagship oncology therapy Keytruda approaching a major patent expiration in 2028, Merck has proactively pursued lifecycle management through innovation in drug delivery. Tactics: Merck developed and secured FDA approval for a subcutaneous formulation of Keytruda for most solid tumor indications in late 2025. Outcome: The new formulation is protected by additional patents extending potentially through 2036. By transitioning patients from the intravenous version ahead of the 2028 patent cliff, Merck aims to preserve a substantial portion of its market share beyond loss of exclusivity.
3. Bristol Myers Squibb: Portfolio Diversification and M&A Strategy Confronted with overlapping patent expirations for its leading products—Eliquis, Opdivo, and Revlimid—Bristol Myers Squibb has pursued aggressive portfolio diversification supported by large-scale acquisitions. Tactics: Over the past two years, BMS has acquired high-growth biotech companies in oncology and immunology while also deploying direct-to-consumer initiatives such as Eliquis360 Support to maintain patient loyalty and volume through flexible pricing models. Outcome: Although Revlimid revenues declined by approximately 40% in the first year following generic entry, BMS plans to launch up to 20 new products by the end of the decade to offset revenue losses and drive long-term growth.