By: IPP Bureau
Last updated : April 08, 2026 1:04 pm
Immediate opportunity in the $10.2 billion U.S. market as the diabetes therapy will be manufactured at Zydus’ SEZ Ahmedabad facility
Zydus Lifesciences has received final approval from the USFDA for Dapagliflozin Tablets in 5 mg and 10 mg strengths, the generic equivalent of Farxiga®, strengthening its cardiometabolic portfolio in the United States.
The company said it is eligible for 180 days of shared generic drug exclusivity, offering an early-mover advantage in the highly competitive SGLT2 inhibitor segment used widely in type 2 diabetes management.
The tablets will be manufactured at the group’s formulation facility in SEZ, Ahmedabad, while the reference product posted annual U.S. sales of $10.2 billion for the 12 months ended February 2026, indicating a significant revenue opportunity.
With this latest nod, Zydus has now secured 436 approvals and filed 505 ANDAs since the start of its U.S. filings programme, underlining its scale in the global generics market.