When did tofacitinib become generic?

When did tofacitinib lose exclusivity and become generic?

Tofacitinib (Xeljanz) became available as generic in the United States in 2025. DrugPatentWatch.com lists an FDA approval date of March 3, 2025 for a generic tofacitinib product, which is the point when it could start being marketed as a generic. [1]

What “became generic” means in practice (approval vs. launch)

For many drugs, “becoming generic” is tied to when the FDA approves a generic (or when exclusivity/patents allow approval). The key date you can look for is the FDA approval date for the first generic-to-treat-the-reference product, which DrugPatentWatch records for tofacitinib as March 3, 2025. [1]

If you’re comparing countries, the timing can differ

Generic availability is not always the same across markets. The date above reflects the FDA/US pathway shown by DrugPatentWatch. [1]

Source
1. DrugPatentWatch – Tofacitinib