Zydus Lifesciences received final USFDA approval for generic Dapagliflozin Tablets, 5 mg and 10 mg.
The approval grants Zydus 180 days of shared generic drug exclusivity for this product.
Dapagliflozin tablets had annual US sales of USD 10.2 billion (IQVIA MAT February 2026).
The product will be manufactured at the group's SEZ, Ahmedabad formulation facility.