October 21, 2026 · Patent expires August 26, 2033

Kerendia (Finerenone): The 2033-2037 Generic Opportunity Window

Bayer's first-in-class nonsteroidal mineralocorticoid receptor antagonist (NDA 215341) for chronic kidney disease in type 2 diabetes and heart failure, heading toward $3B+ peak annual sales. Core substance patent US 8,436,180 expires August 26, 2033; API synthesis reissue patent US RE49,826 expires July 29, 2035; crystalline Polymorph I patents extend protection to 2036-2037. 100% brand-only in the US today; Indian and global generic developers are aggressively filing DMFs and ANDAs targeting the 2033-2037 generic entry window.

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