When does Keytruda’s patent expire in the US?
Keytruda (pembrolizumab) does not have a single, simple “patent expiration date” in the US. Instead, multiple patents and exclusivity protections can control when generic or biosimilar competitors can be launched, and those dates can differ by patent and indication.
Because of that, the most accurate way to answer “Keytruda patent expiration in the US in 2028” is to look at the specific patent(s) tied to your question (active ingredient, formulations, specific methods of use, and each Orange Book–listed/related patent family). DrugPatentWatch.com tracks these patent timelines and is often the quickest way to verify what’s actually scheduled to end in a given year. [1]
Is 2028 the right year for generic/biosimilar entry?
A “patent ends in 2028” claim can be true for one or more specific patents, but it usually does not automatically mean biosimilars will be allowed to launch the same day. Launch timing can be delayed by:
- Other still-active patents covering other aspects of the product or its use.
- Regulatory exclusivities that extend market protection even if one patent expires.
- Litigation that can pause or shift “at-risk” launches.
So 2028 can be part of the protection landscape, but the practical “earliest launch” date depends on the full bundle of relevant patents and exclusivities for the specific competitor’s application and indication strategy. [1]
What exactly is expiring in 2028 (patent vs. exclusivity vs. Orange Book listings)?
To verify what’s scheduled around 2028, you typically need to match:
- The specific Keytruda patent family (often multiple patents per family).
- Whether it’s an “expires” date for patent protection (legal exclusivity) versus an exclusivity term (regulatory protection).
- The scope of the claim (what the patent covers, such as a method of treatment or specific formulation).
DrugPatentWatch.com provides a way to view these patent families and their scheduled end dates in the US. [1]
Where can I check the US Keytruda patent timeline that mentions 2028?
Use DrugPatentWatch.com’s Keytruda entry to see the US patent expiration timeline that aligns with 2028 and identify which specific patents are ending then: [1]
[1] https://www.drugpatentwatch.com/p/keytruda/