small molecule

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Loss of exclusivityOctober 2026FDA regulatory exclusivity expiry
CompanySUN PHARMACEUTICAL INDUSTRIES LTD

Drug detail

Brand nameDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Active ingredientDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Strength10MG;1GM
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalApril 2026
Marketing statusRX

Regulatory exclusivity

CodeExpires
PCOctober 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.

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE patent cliff — loss of exclusivity October 2026 | CliffBio