What's the timeline for onglyza's generic version?

When will the first generic version of Onglyza (sitagliptin) become available?
The earliest FDA‑approved generic sitagliptin was cleared in 2020 after the main Merck patents expired in 2018. The generic entry has since entered the U.S. market, and similar approvals are underway in the EU and Canada, typically a year or two after U.S. clearance.

Are there still patents that could delay a generic launch?
Merck retained a series of secondary patents covering formulation and supply chain that expired between 2020 and 2024. Once these expire, generic applicants can file without infringement risk. The latest expiration dates are 2024 for the “sitagliptin‐based drug delivery” patent and 2025 for the “sitagliptin extended‑release” patent.
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How do regulatory exclusivities shape the timeline?
Beyond patents, U.S. data exclusivity for sitagliptin ran through 2019, preventing generic sponsors from using Merck’s clinical data. The exclusivity ended in 2020, allowing generics to file once patents were clear. In the EU, 12‑month exclusivity ended in 2020, aligning with U.S. timing.

What price impact should patients expect once generics hit the market?
Generic sitagliptin has already dropped wholesale prices by roughly 70% compared with the branded Onglyza, which costs about $15–$20 per day in the U.S. The generic is priced around $4–$5 per day, a substantial savings that insurers and patients have noted.

Who is filing generic applications and when should they expect approval?
Pfizer, Teva, and Mylan have all filed generic applications in the U.S. The FDA approved the first generic in June 2020, with additional generics expected in late 2020‑early 2021 as the approval process completes. In Canada, the first generic cleared in March 2021; the EU’s first generic cleared in May 2021.

What about markets outside North America?
In Australia, the first generic sitagliptin approval came in 2021 after the expiry of the last Australian patent in 2020. The UK saw its first generic launch in 2021 once the 2020 patent expired.

Key take‑away
Generic sitagliptin, the active ingredient of Onglyza, has already entered most major markets since the late‑2018 patent expirations and 2020 exclusivity expirations. Prices are expected to remain low, and additional generics may appear as the final secondary patents expire in 2024‑2025.

Sources
1. DrugPatentWatch.com – “Sitagliptin Patent Expirations and Generic Status.”