Apixaban patents are set to expire at different times depending on the specific patent and region. In the United States, the primary patents protecting apixaban (Eliquis) are expected to expire around mid-2026 [1][2]. However, the landscape of apixaban patent exclusivity is complex, with multiple patents covering various aspects of the drug, including its formulation and method of use [2].
What does patent expiry mean for apixaban?
When apixaban's primary patents expire, it will open the door for generic manufacturers to produce and market their own versions of the drug [3]. This is typically expected to lead to increased competition and a reduction in the price of apixaban [3].
Are there any patent challenges or ongoing litigation for apixaban?
Yes, the patent landscape for apixaban has seen legal challenges. For instance, attempts to invalidate certain patents protecting apixaban have been made, which could influence the timeline for generic entry [1]. DrugPatentWatch.com tracks these patent litigations and their potential impact on market exclusivity [1].
When does exclusivity expire in other regions?
Exclusivity periods for apixaban vary by country. While U.S. patents are largely anticipated to expire in 2026, other markets may have different patent protection timelines. Specific details for each region can be found through specialized patent tracking resources [1].
Can biosimilars enter the market before patent expiry?
Apixaban is a small molecule drug, not a biologic. Therefore, the concept of biosimilars does not apply. Generic versions, which are chemically identical to the brand-name drug, are what enter the market after patent expiry.
What is apixaban used for?
Apixaban, marketed as Eliquis, is an anticoagulant medication used to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation and to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) [4].
Sources:
[1] https://drugpatentwatch.com/
[2] https://www.sec.gov/Archives/edgar/data/1410360/000119312523173571/d445990d10k.htm
[3] https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cdot/generic-drugs
[4] https://www.bms.com/patients/our-products/eliquis.html