Zydus Gets USFDA Nod for Dapagliflozin Tablets, Secures 180-Day Exclusivity

Zydus Lifesciences has received final approval from the US Food and Drug Administration for Dapagliflozin tablets in 5 mg and 10 mg strengths, the company said in a press release. 

The drug which is used to improve glycaemic control in adults with type 2 diabetes will be manufactured at the company’s SEZ facility in Ahmedabad.

With this approval, Zydus will be eligible for 180 days of shared generic exclusivity in the US market, the release said.

Dapagliflozin recorded annual sales of $10.2 billion in the US as of February 2026, highlighting a significant market opportunity.

The company said it now has a total of 436 approvals and has filed 505 abbreviated new drug applications since it began filings in 2003-2004.