When Does Onglyza's Main Patent Expire?
Onglyza (saxagliptin), made by AstraZeneca and Bristol-Myers Squibb, has its primary composition patent (U.S. Patent 6,995,181) expiring on July 26, 2025. This covers the core drug molecule and opens the door for generic entry shortly after, assuming no further delays.[1][2]
Pediatric Exclusivity Extension
The FDA granted six months of pediatric exclusivity, pushing the effective non-patent exclusivity end date to January 27, 2026. Generics can launch then without patent infringement risk from this protection.[1][2]
Key Patent Challenges and Status
Multiple generics firms, including Mylan (now Viatris), Teva, and Lupin, filed Paragraph IV challenges under the Hatch-Waxman Act. AstraZeneca settled with several, allowing entry as early as February 17, 2026 for some, while others await court rulings. No generics are approved yet; the first ANDAs target post-2026 launch.[2][3]
Other Patents and Litigation Risks
Secondary patents cover formulations and methods (e.g., U.S. Patents 8,414,921 expiring 2028; 9,193,723 to 2032) but face invalidity challenges. Courts have invalidated some, reducing barriers. Full generic competition likely starts mid-2026, though listed patents could trigger 30-month stays if litigated.[2]
Generic Approvals and Launch Expectations
FDA has accepted 12+ ANDAs for saxagliptin. Viatris leads with tentative approval; launch ties to the 2026 date. Fixed-dose combos like Kombiglyze XR (saxagliptin/metformin) follow similar timelines, with patents to 2029 but earlier settlements possible.[1][2]
[1]: FDA Orange Book for Saxagliptin
[2]: DrugPatentWatch.com - Onglyza Patents
[3]: FDA Paragraph IV Patent Certifications