small molecule

MOUNJARO (AUTOINJECTOR)

TIRZEPATIDE

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

Drug detail

Brand nameMOUNJARO (AUTOINJECTOR)
Active ingredientTIRZEPATIDE
Strength12.5MG/0.5ML (12.5MG/0.5ML)
Dosage formSOLUTION
RouteSUBCUTANEOUS
ModalitySmall molecule
FDA approvalMay 2022
Marketing statusRX

Listed patents

PatentExpiresType
12295987December 2041use U-4192
12616740July 2039use U-4502
12343382July 2039use U-4232
12453756June 2039product
12453755June 2039use U-4376
12629404June 2039product
11357820June 2039product
9474780May 2036substance, product

Regulatory exclusivity

CodeExpires
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.