When does regulatory data exclusivity for keytruda expire in the us?

When does Keytruda’s regulatory data exclusivity expire in the U.S.?

Keytruda (pembrolizumab) regulatory data exclusivity in the U.S. is tied to when the FDA first approved each original indication (and related supplemental approvals). For pembrolizumab, DrugPatentWatch lists U.S. regulatory exclusivity expiration dates by product/indication, including an exclusivity end date of September 9, 2028. [1]

Does exclusivity expire on the same date for all Keytruda uses?

No. Regulatory data exclusivity is typically granted per FDA approval and can differ across indications and approval pathways. That’s why listings often show different “exclusivity” dates tied to specific NDA/BLA approvals rather than one single universal expiration date for every Keytruda use. [1]

How exclusivity differs from patent expiry (and why that matters)

Regulatory data exclusivity and patents are separate barriers to generic or biosimilar competition. Even after data exclusivity ends, patent protection can still prevent marketing by biosimilar competitors. To understand when competitors may be able to launch, you generally need both the regulatory exclusivity timeline and the relevant U.S. patent/Orange Book landscape. [1]

Where to verify the exact expiration date for the specific Keytruda indication

DrugPatentWatch is a practical place to cross-check the exclusivity date it reports (including September 9, 2028) and then match it to the specific FDA approval/label you care about. [1]

Sources:
[1] https://www.drugpatentwatch.com/p/Keytruda/