Keytruda's FDA Approval Year
Keytruda (pembrolizumab) received its initial FDA approval on September 4, 2014, for treating unresectable or metastatic melanoma in patients whose tumors express PD-L1.[1]
What conditions has Keytruda been approved for since then?
The FDA has since expanded approvals to over 30 indications, including non-small cell lung cancer (2015), head and neck squamous cell carcinoma (2016), and more recent ones like triple-negative breast cancer (2021) and esophageal carcinoma (2021).[1][2] These build on its PD-1 inhibitor mechanism, targeting cancers with high unmet needs.
Who manufactures Keytruda?
Merck & Co. (known as MSD outside the US) developed and markets Keytruda, which generated $25 billion in 2023 sales, making it the world's top-selling drug.[3]
When do Keytruda's patents expire?
Core composition-of-matter patents expire in 2028 in the US, with others extending to 2036 via pediatric exclusivity and method-of-use claims. Challenges from biosimilar makers like Samsung Bioepis and Viatris are ongoing in litigation.[4] DrugPatentWatch.com
Are biosimilars available yet?
No US biosimilars are approved; the first potential entry aligns with 2028 patent cliffs, though lawsuits could delay this to the early 2030s.[4]
[1]: FDA.gov - Keytruda Approval History
[2]: FDA.gov - Novel Drug Approvals for 2021
[3]: Merck.com - 2023 Annual Report
[4]: DrugPatentWatch.com - Keytruda Patent Expiration