Zydus Lifesciences Receives USFDA Approval for Dapagliflozin Tablets, Eyeing USD 10.2bn Market

Zydus Lifesciences Ltd has received final approval from the USFDA for Dapagliflozin Tablets, 5 mg and 10 mg, a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated for type 2 diabetes mellitus. The approval grants Zydus 180 days of shared generic drug exclusivity. The tablets will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad. Dapagliflozin tablets had annual sales of USD 10.2bn in the United States (IQVIA MAT February 2026). Zydus now has 436 approvals and has filed 505 ANDAs since the commencement of the filing process in FY 2003-04.