small molecule

JANUMET XR

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Loss of exclusivityMay 2027latest FDA-listed patent expiry
CompanyMERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC

Drug detail

Brand nameJANUMET XR
Active ingredientMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Strength500MG;EQ 50MG BASE
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2012
Marketing statusRX

Listed patents

PatentExpiresType
7326708*PEDMay 2027
7326708November 2026substance, product

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.

JANUMET XR patent cliff — loss of exclusivity May 2027 | CliffBio