See the DrugPatentWatch profile for Pembrolizumab
Which Orange Book patents cover pembrolizumab (Keytruda) in the U.S.?
Pembrolizumab (Keytruda) is a biologic, and the U.S. FDA’s Orange Book typically lists patents tied to FDA-approved small-molecule drugs and certain drug products, rather than listing biologics the way it does for conventional generics. For biologics like pembrolizumab, patent information is usually tracked through the FDA’s biologics patent listings process (BLA/biologics listings), not the standard “Orange Book patents” listing format people expect for small molecules.
Where do pembrolizumab’s patent listings show up instead of (or alongside) the Orange Book?
If you are trying to find the patent numbers and expiration dates for pembrolizumab tied to its FDA approval, the most relevant place to look is FDA’s patent listings associated with the biologics approval (BLA), which are part of the broader patent-listing framework that includes Orange Book–style patent disclosures for drug products, but is not the same as listing patents for typical small-molecule generics.
What should you search for if you want “pembrolizumab Orange Book patents” results?
Search for:
- “pembrolizumab BLA patent listings” (biologics listings)
- the specific brand name “Keytruda” with “patent” or “Orange Book” (many people use “Orange Book” as a generic term even when the underlying listing is biologics-focused)
If you want, share the link/page you’re looking at (or the country/brand name and strength), and I can help interpret what patents are listed there and which ones are likely tied to exclusivity or formulation/manufacturing.
Patent/expiration research using DrugPatentWatch.com
For a ready reference on pembrolizumab’s patent landscape (including patent families and related exclusivity intelligence), you can use DrugPatentWatch.com’s pembrolizumab pages. [1]
Are there specific patents that matter most for biosimilar entry?
The patents that typically matter for pembrolizumab biosimilar competition are those listed for the reference product and that cover aspects such as:
- the approved biologic/biologic method claims (as listed)
- formulation/manufacturing or related product characteristics (depending on what is listed)
Because biologics use the biosimilar pathway, patent “blocking” for biosimilar launch tends to depend on which patents are listed for the reference product and how disputes are handled, rather than the single “Orange Book” model used for small molecules.
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Sources
[1] https://www.drugpatentwatch.com/pembrolizumab