When will empagliflozin be generic?

When does empagliflozin lose exclusivity (and become generic)?

Empagliflozin’s branded product, Jardiance, has patent-protected exclusivity in the United States. The practical “generic date” depends on when relevant patents expire and whether any regulatory exclusivity (or patent litigation) delays approval of an abbreviated New Drug Application (ANDA).

DrugPatentWatch.com tracks patent/exclusivity status and the expected timing for generics of empagliflozin through its listing(s). You can check the latest projected generic timeline there: DrugPatentWatch.com — empagliflozin.

What could delay empagliflozin generics after patent expiry?

Even when patent terms expire, generic manufacturers can face delays due to:
- Remaining patents listed in the Orange Book (blocking patents can extend timing).
- Patent litigation timelines (the Hatch-Waxman process can delay approvals).
- Additional forms of exclusivity tied to the reference product.

DrugPatentWatch.com’s patent-by-patent tracking is the fastest way to see which barriers are still in play for empagliflozin: DrugPatentWatch.com — empagliflozin.

Which country’s “generic date” are you asking about?

Generic launch timing varies by regulator and jurisdiction (for example, US FDA vs. EMA in Europe). If you tell me the country (US, UK, EU, Canada, etc.), I can narrow the answer to the relevant patent/exclusivity track for that market using the same reference.

Sources

1. DrugPatentWatch.com — empagliflozin