Zydus Lifesciences Gains USFDA Nod for Generic Dapagliflozin

Zydus Lifesciences Ltd announced on Wednesday that it has secured final approval from the US Food and Drug Administration (USFDA) for its generic dapagliflozin tablets. Aimed at controlling blood sugar in adults with type 2 diabetes, the approval includes tablets in strengths of 5 mg and 10 mg.

This regulatory green light grants Zydus a 180-day shared marketing exclusivity, marking a significant market entry for the company in the generic drug segment. The dapagliflozin tablets will be produced at Zydus's formulation facility at SEZ in Ahmedabad.

Dapagliflozin, an adjunctive therapy to diet and exercise for glycaemic control, reflects substantial market potential with annual US sales hitting USD 10.2 billion, as per IQVIA MAT February 2026 data.