See the DrugPatentWatch profile for Keytruda
When does Keytruda’s primary U.S. patent expire (2028)?
Keytruda’s key U.S. patent expiration timing that is commonly cited for 2028 relates to the drug’s biologic protection. DrugPatentWatch.com lists a Keytruda (pembrolizumab) “Primary” patent expiration in 2028 for the United States. [1]
If you want, share the specific Keytruda patent number (or the DrugPatentWatch entry you’re looking at), and I can map that exact patent to its stated U.S. expiration date.
Why you might see different Keytruda “expiration” dates (patents vs. exclusivity)
Drug “expiration” can mean different things:
- Patent expiration (the right held by the patent owner to prevent certain copying/manufacturing).
- Regulatory exclusivity (a period after approval during which the FDA may restrict certain competing products even if patents are still in force or if patent status differs).
Because “primary” is a specific label on patent-tracking sites, it’s normal to see other later dates too (from additional patents, line extensions, or combination-related claims). [1]
What happens around the 2028 date
If a primary U.S. patent expires in 2028, biosimilar developers may still face:
- Other unexpired Keytruda patents (often multiple patents protect different aspects and uses),
- FDA review requirements and patent certifications (with potential litigation under the Hatch-Waxman/BPCIA framework for biologics),
- Practical launch timing that depends on court outcomes and manufacturing readiness.
Patent trackers like DrugPatentWatch.com focus on the listed patent-expiration dates, which may not fully capture the timing of real market entry. [1]
Source
[1] https://www.drugpatentwatch.com/p/keytruda-kettruda-pembrolizumab