small molecule

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Loss of exclusivityNovember 2026FDA regulatory exclusivity expiry
CompanySandozSee this company's full patent-cliff portfolio

Drug detail

Brand nameSITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Active ingredientMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Strength500MG;EQ 50MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalDecember 2025
Marketing statusRX

Regulatory exclusivity

CodeExpires
PCNovember 2026

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE patent cliff — loss of exclusivity November 2026 | CliffBio