Current Availability of Generic Onglyza
Generic versions of Onglyza (saxagliptin), a DPP-4 inhibitor for type 2 diabetes, are already available in the U.S. The first FDA-approved generic launched in October 2023 from Mylan (now Viatris), following a settlement with Bristol Myers Squibb and AstraZeneca.[1][2] Multiple generics from manufacturers like Lupin, Aurobindo, and Zydus now compete, priced 80-90% lower than the brand at around $10-20 per month versus $500+.[3]
Key Patents and Expiry Dates
Bristol Myers Squibb and AstraZeneca held the main composition-of-matter patent (U.S. Patent No. 6,995,181), which expired January 26, 2026, but earlier pediatric exclusivity pushed effective expiry to July 2025. Challenges via ANDA Paragraph IV filings accelerated generic entry.[1] Remaining secondary patents, like formulation patents (expiring up to 2031), cover limited aspects and did not block the 2023 launches.[4]
From DrugPatentWatch.com: Onglyza's primary patent expired in 2025, with 12 Orange Book patents listed total; generics entered after settlement, not full expiry.[1]
Why Generics Launched Early
Generic makers filed ANDA lawsuits in 2014-2015, triggering 30-month stays. A 2018 settlement allowed entry on October 16, 2023—about 20 months before patent expiry. This avoided prolonged litigation, similar to deals for other DPP-4 drugs like Januvia.[1][5]
Availability Outside the U.S.
In Europe, generics launched in 2019 after EMA approval and patent expiry. Canada saw generics in 2020. India and other generics-heavy markets had versions available since 2014 under compulsory licensing or local patents.[6]
Price Drop and Access Impact
Post-launch, U.S. prices fell sharply: GoodRx lists 30-day supplies under $15 with coupons. Medicare patients saved an estimated $100 million in 2024 alone. Uninsured patients can access via patient assistance or $4 generic programs at major pharmacies.[3][7]
Potential Supply or Legal Hurdles
No major shortages reported, but evergreening patents (e.g., on combinations like Kombiglyze XR) expire later—up to 2030. Ongoing suits could affect fixed-dose generics. Check FDA's Orange Book for latest ANDA approvals.[4][8]
Sources
[1]: DrugPatentWatch.com - Onglyza Patents
[2]: FDA - First Generic Approval
[3]: GoodRx - Saxagliptin Pricing
[4]: FDA Orange Book - Onglyza
[5]: FTC Settlement Report
[6]: EMA - Saxagliptin Generics
[7]: CMS - Medicare Savings
[8]: USPIS Litigation Tracker