Zydus Lifesciences Limited has informed the Exchange regarding a press release dated April 08, 2026, titled "Zydus receives final approval from USFDA for Dapagliflozin Tablets, 5 mg and 10 mg".
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Zydus Lifesciences has received final approval from the USFDA to manufacture and sell Dapagliflozin Tablets in 5 mg and 10 mg doses. Dapagliflozin is an SGLT2 inhibitor used to control blood sugar in adults with type 2 diabetes. With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity, giving it a window to capture market share before other generics enter. The drug had annual US sales of USD 10.2 billion as of February 2026 (IQVIA data), representing a large addressable market. The tablets will be manufactured at Zydus's SEZ facility in Ahmedabad. With this approval, Zydus now has 436 total USFDA approvals and has filed 505 ANDAs since FY 2003-04.
This approval opens access to a multi-billion dollar US market and the 180-day exclusivity period gives Zydus a competitive advantage to establish its generic version. The large market size signals meaningful revenue potential, though actual impact depends on pricing and market penetration.