The Keytruda (Pembrolizumab) Opportunity Window: 2028 to 2042
Merck's core US patent on Keytruda (pembrolizumab), US Patent 8,354,509, is expected to lose exclusivity in 2028. No pembrolizumab biosimilar is yet approved or selling in the US. Real Indian biosimilar developers already positioned: Zydus Lifesciences (FYB206, licensed from Formycon, pivotal Dahlia PK study complete, preparing an FDA filing), Dr. Reddy's Laboratories (partnered with Alvotech), and Biocon (reported to be pursuing a pembrolizumab biosimilar). Merck's own secondary patent estate, including a subcutaneous reformulation extending to roughly 2033 and over 50 dosing/manufacturing patents that could run through 2042, means real biosimilar competition may arrive well after the headline 2028 date. Keytruda had 2025 global sales of approximately 31.7 billion dollars.
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