Who Holds the Keytruda Patents?
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., holds the primary patents for Keytruda (pembrolizumab), including key composition-of-matter and method-of-use patents.[1][2]
When Do Keytruda Patents Expire?
The main U.S. composition-of-matter patent (US 8,354,509) expires in 2028, with pediatric exclusivity potentially extending it to 2029. Other patents, like formulation and method-of-use ones, extend protection into the mid-2030s.[2]
Who Makes and Sells Keytruda?
Merck & Co., Inc. manufactures and markets Keytruda worldwide under its MSD subsidiary. It's the sole originator, with no authorized generics yet.[1]
Are There Patent Challenges?
Multiple companies, including Samsung Bioepis, Sandoz, and Fresenius Kabi, have filed FDA abbreviated biologics license applications (aBLAs) with Paragraph IV challenges against Merck's Keytruda patents, triggering litigation. Merck has settled some, delaying biosimilar entry until at least 2028.[2]
Can Biosimilars Launch Soon?
No, due to ongoing patent exclusivity and litigation. The first potential U.S. biosimilars target 2028 or later, depending on court outcomes.[2]
[1] FDA Orange Book: https://www.accessdata.fda.gov/scripts/cder/ob/
[2] DrugPatentWatch.com: https://www.drugpatentwatch.com/p/tradename/KEYTRUDA