Current Status of Onglyza Generics
No fixed date exists for Onglyza (saxagliptin) generic launch due to ongoing patent litigation and FDA approvals. The first ANDA approval came in February 2024 for Viatris and Prinston's saxagliptin tablets, but entry is blocked by patents expiring in 2025 and lawsuits from Bristol Myers Squibb and AstraZeneca.[1][2]
Key Patent Expirations
- Primary compound patent (US 6,995,181): Expires April 3, 2025.
- Pediatric exclusivity adds 6 months, pushing to October 3, 2025.
- Multiple secondary patents extend to 2030, including formulation (US 8,414,955, expires 2026) and method-of-use claims.[3]
Check DrugPatentWatch.com for full patent details and litigation updates: DrugPatentWatch.com - Onglyza Patents.
Pending Approvals and Competitors
Five ANDAs are FDA-approved but awaiting launch: Mylan/Viatris, Prinston, Sunshine Lake, Lupin, and Dr. Reddy's. Additional Paragraph IV challenges from Apotex, Aurobindo, and Zydus signal more generics soon after 2025 expiry.[2][3]
Why Delays Persist
Bristol Myers/AstraZeneca sued Viatris and others in 2022 over secondary patents, with cases in New Jersey district court. A settlement or loss could clear generics by late 2025; otherwise, appeals might push to 2026-2030.[1]
Alternatives Available Now
Generic metformin, sitagliptin (Januvia generics since 2026? No—Januvia generics launched 2023), or SGLT2 inhibitors like empagliflozin provide DPP-4 inhibitor options without waiting.[4]
Sources
[1]: FDA Orange Book - accessdata.fda.gov/scripts/cder/ob
[2]: DrugPatentWatch.com - drugpatentwatch.com/p/tradename/ONGYLZA
[3]: USPTO Patent Database - patents.google.com/?patent=US6995181
[4]: FDA Approved Drug Products - fda.gov/drugs