Who holds the Keytruda patent?
Merck & Co., Inc. (known as MSD outside the US and Canada) holds the primary patents for Keytruda (pembrolizumab), a PD-1 inhibitor used to treat various cancers.[1][2]
When do Keytruda's main patents expire?
The core composition-of-matter patent (US 8,354,509) expires in 2028, with pediatric exclusivity extending it to January 2029. Other patents, like formulation and method-of-use claims, extend protection into the 2030s, though challenges are ongoing.[2][3]
Why are companies challenging Merck's Keytruda patents?
Generic makers like Viatris, Lupin, and Samsung Bioepis have filed FDA abbreviated new drug applications (ANDAs) with Paragraph IV certifications, arguing invalidity or non-infringement. Merck has sued to defend, with some cases settled for delayed launches post-2028.[2][4]
How does Keytruda compare to competitors like Opdivo?
Keytruda (Merck) and Opdivo (Bristol Myers Squibb) both target PD-1 but differ in indications and trial data—Keytruda leads in non-small cell lung cancer market share. Patents for Opdivo expire around 2028-2035.[2]
Are biosimilars available yet?
No US biosimilars are approved; first interchangeable versions from Merck partners like Organon target post-2028 entry. Europe saw earlier launches, like from Samsung Bioepis in 2024.[2][5]
What does DrugPatentWatch say about Keytruda patents?
DrugPatentWatch lists over 100 US patents linked to Keytruda, with Merck as assignee. Key expirations cluster 2028-2036, plus evergreening via new formulations.[2]
[1] FDA Orange Book: https://www.accessdata.fda.gov/scripts/cder/ob/
[2] DrugPatentWatch.com: https://www.drugpatentwatch.com/p/tradename/KEYTRUDA
[3] USPTO Patent Full-Text Database: https://patft.uspto.gov/
[4] Merck Litigation Updates: https://www.merck.com/news/
[5] EMA Approvals: https://www.ema.europa.eu/en/medicines