Zydus wins US FDA nod for generic diabetes drug dapagliflozin

Shares of drug maker Zydus Lifesciences Ltd. have gained over 1% on Wednesday (April 8) morning after it announced getting final approval from the US Food and Drug Administration (FDA) for a diabetes drug.

The approval was granted for generic version of dapagliflozin tablets in 5 mg and 10 mg.

The drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes. The approval references AstraZeneca’s Farxiga, a widely prescribed branded version of dapagliflozin.

Zydus said it will be eligible for 180 days of shared market exclusivity for the generic drug in the US while the tablets will be manufactured at the company’s formulation facility in a special economic zone in Ahmedabad.

According to IQVIA data, dapagliflozin tablets recorded annual sales of about $10.2 billion in the US for the 12 months ended February 2026.

In the regulatory exchange, the company also said it has received 436 approvals from the US FDA and has filed 505 abbreviated new drug applications (ANDAs) since it began filings in the FY2003-04.

Shares of the company was last seen trading at ₹885.95 apiece which is up 1.43% for the day.

In the same diabetic care market, the company has also partnered with Lupin Ltd. to co-market semaglutide injection in India. Their partnership covers semaglutide injection (15 mg/3 ml) delivered through a patient-friendly reusable pen device.

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