Apixaban's Main Patent Expiry
Apixaban, the active ingredient in Eliquis, has its primary composition of matter patent (U.S. Patent No. 6,967,208) expiring in 2026.[1] This covers the core chemical structure and is listed in the FDA's Orange Book.
When Does Eliquis Lose Market Exclusivity?
Eliquis exclusivity ends in 2028, combining patent expiry with pediatric extensions. Generic entry is most likely after this date, though lawsuits could delay it further.[1][2]
Key Patents Still Blocking Generics
Several secondary patents extend protection:
- Dosage regimen patent (U.S. Patent No. 9,326,945): Expires 2031.[1]
- Crystalline forms and processes (e.g., U.S. Patent No. 10,112,904): Some expire 2033.[1]
Bristol Myers Squibb and Pfizer defend these aggressively against ANDA filings.
Are Generics Already Approved?
No full generic approvals yet. The FDA has tentative approvals for some, like from Mylan and Sandoz, but they await final patent settlements. First generics could launch via authorized pathways in 2026-2028.[2]
How Does This Compare to Other DOACs?
| Drug | Brand | Main Patent Expiry | Generic Entry Expected |
|------|-------|---------------------|-----------------------|
| Apixaban | Eliquis | 2026 | 2028 |
| Rivaroxaban | Xarelto | 2024 | Launched 2024 |
| Dabigatran | Pradaxa | 2029 | Pending |
| Edoxaban | Savaysa | 2031 | Pending |
Apixaban lags due to longer secondary patents.[1][3]
[1]: DrugPatentWatch.com - Eliquis (Apixaban) Patents
[2]: FDA Orange Book - Apixaban
[3]: DrugPatentWatch.com - DOAC Patent Comparison