Core U.S. Patent Expiration for Apixaban (Eliquis)
Apixaban, the active ingredient in Eliquis made by Bristol-Myers Squibb and Pfizer, has its primary U.S. composition-of-matter patent (US 6,967,208) expiring October 2, 2026.[1][2] This covers the chemical structure and triggers generic entry potential, though other patents extend protection.
When Can Generics Enter the Market?
Generics face multiple layered patents. Key ones include:
- Formulation patent (US 9,326,945): Expires March 28, 2031.
- Dosing regimen patent (US 9,326,944): Expires March 28, 2031.
- Pediatric exclusivity adds 6 months, pushing effective market entry to around September 2031.[1][2] FDA tentative approvals for generics exist, but launches await final patent resolutions.
Ongoing Patent Challenges
Companies like Mylan, Lupin, and Sigmapharm have filed ANDAs challenging Bristol-Myers Squibb's Orange Book patents, leading to Hatch-Waxman litigation. Courts upheld most in 2022-2023, delaying generics until at least 2031 unless appealed successfully.[2][3]
Ex-U.S. Patent Timelines
- Europe (EP 1539127): Expires February 14, 2028, with supplementary protection to 2031 in some countries.[1]
- Japan: Core patent expired 2023; generics available there.[4]
Who Makes Apixaban and Generic Competitors?
Bristol-Myers Squibb and Pfizer market Eliquis. Approved generic makers include MSN Labs (first ANDA approval 2023), with others like Aurobindo and Dr. Reddy's in line post-2031.[3][5]
[1]: DrugPatentWatch.com - Apixaban Patents
[2]: FDA Orange Book - Eliquis
[3]: Paragon Biosciences - Apixaban Litigation Update
[4]: EMA - Eliquis Patent Info
[5]: FDA ANDA Approvals