Eliquis Faces Major Patent Cliff as European Exclusivity Expires in May 2026
核心洞察
Bristol Myers Squibb (搜索) and Pfizer's blockbuster anticoagulant Eliquis is projected to decline 15.2% in sales due to European patent expiry on May 19, 2026.
The drug has generated approximately $82.6 billion in revenue since 2011, with sales forecast to peak at $14.2 billion in 2025 before plummeting 92.3% by 2030.
Companies are implementing a direct-to-patient program in the US offering over 40% prescription reductions to mitigate competition ahead of US patent expiry in 2028.
Bristol Myers Squibb (搜索) and Pfizer are bracing for a dramatic decline in sales of their blockbuster anticoagulant Eliquis (apixaban), with projections showing a 15.2% drop this year as the drug approaches its European patent expiry on May 19, 2026. The BMS-Pfizer alliance has dominated the anticoagulant market since 2011, generating approximately $82.6 billion in revenue according to GlobalData's Sales and Forecast Database.
Market Dominance and Clinical Impact
Eliquis first entered the European market in May 2011 following MHRA approvals for various thromboembolic diseases (搜索), revolutionizing thromboprophylaxis treatment. As a second-generation direct oral anticoagulant (DOAC), Eliquis prevents clot formation through direct and reversible inhibition of free and clot-bound factor Xa (搜索), a key enzyme in the clotting cascade.
The drug's success stems from its significantly higher safety profile compared to traditional anticoagulants, with reduced monitoring requirements that set it apart from conventional treatments like warfarin. These advantages have established Eliquis as a first-line treatment or prophylaxis for various cardiovascular diseases (搜索), including pulmonary embolism (搜索) and non-valvular atrial fibrillation (搜索).
Unprecedented Growth Followed by Steep Decline
Eliquis has demonstrated remarkable growth with a compound annual growth rate of 108.3% since its European market entry. Sales are forecast to peak at just under $14.2 billion in 2025, followed by the predicted 15.2% drop as European exclusivity expires and generic competitors enter the market.
The financial impact extends far beyond the initial decline, with overall sales predicted to plummet by 92.3% by 2030 compared to 2025 levels. This dramatic forecast underscores the magnitude of the approaching patent cliff.
Patent Extension Strategy
BMS and Pfizer successfully extended Eliquis' market exclusivity through a supplementary protection certificate (SPC) filing, pushing the expiry date from the original September 2022 to May 2026. This strategic extension has generated approximately $29.5 billion in additional revenue, effectively delaying the patent cliff by nearly four years.
US Market Retention Efforts
With US patent expiry expected in 2028, the companies announced a direct-to-patient Eliquis program in July 2025, which became effective in September 2025. This initiative provides underinsured, uninsured, or self-pay American patients with prescription reductions of over 40%.
The program specifically targets cash-paying patients, who constitute up to 10% of the patient population, aiming to mitigate incoming competition and expand market access ahead of generic entry.
Market Transformation Ahead
The May 19, 2026 European patent expiry will mark the beginning of a major transformation in the anticoagulation market. Generic competition is expected to drive rapid sales decline, fundamentally altering the competitive landscape that Eliquis has dominated for over a decade.
While BMS and Pfizer's US market retention strategies may provide some protection over the next two years, the companies face the challenge of whether these efforts will be sufficient to offset the forecast sales decline following eventual global patent expiry.