Zydus Lifesciences has received final approval from the USFDA to market Dapagliflozin tablets (5 mg and 10 mg). This medication, used as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, represents a significant market opportunity. The company has also secured 180 days of shared generic drug exclusivity for the product, which generated annual sales of USD 10.2 billion in the United States.
Expanding the Diabetes Portfolio
Zydus Lifesciences has reached a major milestone with the final approval from the United States Food and Drug Administration for Dapagliflozin tablets in 5 mg and 10 mg strengths. The drug is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a critical class of medication for managing glycaemic levels in patients diagnosed with type 2 diabetes mellitus.
Market Opportunity and Manufacturing
The product, which is a generic version of Farxiga, enters a high-value market segment. According to IQVIA MAT February 2026 data, Dapagliflozin tablets recorded annual sales of USD 10.2 billion in the United States. Zydus is positioned to capture a portion of this market, benefitting from 180 days of shared generic drug exclusivity. Production of the tablets will take place at the group’s dedicated formulation manufacturing facility located in the SEZ, Ahmedabad.
Strategic Growth Milestones
This approval adds to the company’s robust portfolio, bringing its total count to 436 approvals. Since the inception of its filing process in the 2003-04 fiscal year, Zydus has submitted 505* ANDAs, demonstrating a consistent commitment to expanding its global generic footprint. (*Data reported as of December 31, 2025).
Source: BSE
