Keytruda Patent Protection
0 patents · Merck Sharp & Dohme LLC
Biosimilar Pathway
Keytruda (pembrolizumab) is a biologic, not a small-molecule drug. Biologics are not listed in the FDA Orange Book and do not face conventional “generic” competition. Instead, follow-on competitors called biosimilars can be approved through the FDA’s BPCIA pathway, typically after the reference product’s 12-year exclusivity period and the resolution of any patent litigation.
For the current biosimilar approvals and exclusivity status of Keytruda, see the authoritative FDA Purple Book listing for pembrolizumab.
Related Drug Patent Expirations
0 patents · Genentech Inc.
9 patents · earliest expires 2033 · Gilead Sciences Inc.
0 patents · Novartis AG
0 patents · Janssen Biotech Inc.
0 patents · Regeneron Pharmaceuticals Inc.
2 patents · earliest expires 2027 · Bristol-Myers Squibb Company
For Keytruda, the underlying data on this page comes from the FDA Orange Book and USPTO patent records. The breakdown above is the federal record; the paragraphs below add the per-entity context that makes the headline numbers usable for a real decision rather than just a data lookup.
The methodology behind every numeric value on this page is publicly documented on the the FDA Orange Book and USPTO patent records portal and described in detail on this site’s methodology page. Refresh cadence varies by underlying series; the page surfaces the as-of date for each number so readers can trace any figure back to the source release.
For readers using this page as a decision input, the related-entity pages elsewhere on the site provide the comparison set. The most useful comparison for Keytruda is typically a peer within U.S. brand-name drugs with similar size, similar exposure, or similar geography — not the national-level summary alone.