The Complex Patent History of Eliquis
Eliquis (apixaban), developed by Bristol Myers Squibb and Pfizer, is a widely used anticoagulant facing delays in generic availability due to a complex history of patent protection and legal challenges. The FDA first approved Eliquis in 2012, and in December 2019, it approved applications for the first generic versions from Micro Labs Limited and Mylan Pharmaceuticals Inc.. However, the brand manufacturers filed lawsuits to protect their patents, which were upheld by the U.S. Court of Appeals for the Federal Circuit in September 2021. A key patent, originally set to expire in 2022, was extended to November 2026. As a result of these legal actions and settlements, the earliest generic apixaban is now expected to enter the U.S. market is April 1, 2028.
Why Generic Eliquis Isn't Coming in 2025
Despite FDA approval for generic apixaban applications in 2019, the market launch is delayed because patents grant brand-name manufacturers exclusive rights for a set period. Bristol Myers Squibb and Pfizer have defended their patents through litigation and settlement agreements with generic companies. These settlements typically allow the generic drug to launch after a specified waiting period, overriding the earlier FDA approval. Additionally, patent extensions further prolong market exclusivity, delaying generic competition and keeping the price of brand-name Eliquis high.
Comparing Anticoagulant Options: Eliquis vs. Alternatives
Patients looking for alternatives to the high cost of brand-name Eliquis should consult their healthcare provider about other anticoagulant options. While generic apixaban won't be available in 2025, other medications are on the market.
| Feature | Eliquis (Apixaban) | Warfarin (Coumadin) | Xarelto (Rivaroxaban) |
|---|---|---|---|
| Active Ingredient | Apixaban | Warfarin Sodium | Rivaroxaban |
| Generic Available | No (in U.S. until at least 2028) | Yes | Yes (limited generic options available) |
| Cost | High ($500+ per month without insurance) | Very low (often under $10 per month) | High (similar to Eliquis, but generic available) |
| Monitoring | No routine blood monitoring required | Requires frequent INR blood testing | No routine blood monitoring required |
| Dietary Restrictions | No significant dietary restrictions | Significant dietary restrictions (e.g., Vitamin K intake) | No significant dietary restrictions |
| Drug Interactions | Fewer known drug interactions | Numerous drug and supplement interactions | Fewer known drug interactions |
| Primary Advantage | Predictable dosing, no monitoring | Low cost | Once-daily dosing for many indications |
| Primary Disadvantage | High cost until generic launch | High monitoring, dietary, and interaction burden | Similar high cost to Eliquis |
The Impact of Delayed Generic Entry
The continued delay of generic apixaban significantly impacts patients who face high costs for brand-name Eliquis. Although the Inflation Reduction Act will cap annual out-of-pocket costs for Medicare Part D beneficiaries at $2,000 starting in 2025, many patients still face substantial expenses. Generic availability typically leads to lower prices, improving access and reducing healthcare costs. The extended patent protection delays these benefits for consumers. Until generic apixaban is available, patients may explore patient assistance programs or discuss switching to more affordable, older medications like warfarin with their doctors.
Conclusion
Despite the FDA approving generic apixaban applications in 2019, its market launch has been repeatedly postponed due to patent protection, extensions, and legal settlements. Therefore, the answer to the question "Is Eliquis going to be generic in 2025?" is no, with the earliest U.S. market entry anticipated in 2028. This situation highlights the complexities of the pharmaceutical market and its impact on drug costs and patient access. Patients concerned about the cost of Eliquis should consult with their healthcare providers to explore alternative treatment or financial assistance options.
