small molecule

MOUNJARO

TIRZEPATIDE

Loss of exclusivityDecember 2041latest FDA-listed patent expiry
CompanyELI LILLY AND CO

Drug detail

Brand nameMOUNJARO
Active ingredientTIRZEPATIDE
Strength10MG/2.4ML (4.17MG/ML)
Dosage formSOLUTION
RouteSUBCUTANEOUS
ModalitySmall molecule
FDA approvalJanuary 2026
Marketing statusRX

Listed patents

PatentExpiresType
12295987December 2041use U-4192
12343382July 2039use U-4230
12616740July 2039use U-4502
9474780May 2036substance, product

Regulatory exclusivity

CodeExpires
NPPDecember 2028
NCEMay 2027

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.