Aurobindo Pharma Limited has informed the Exchange regarding a press release dated April 07, 2026, titled "Aurobindo Pharma receives USFDA approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets".
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Aurobindo Pharma has received final USFDA approval to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in four dosage strengths (5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg). The product is bioequivalent and therapeutically equivalent to AstraZeneca's reference listed drug Xigduo XR. Manufacturing will be handled by APL Healthcare Limited, a wholly owned subsidiary. The approved product targets an estimated US market size of US$ 514 million (MAT February 2026). As one of the first ANDA applicants with a paragraph IV certification, Aurobindo is eligible for 180 days of shared generic drug exclusivity. The company now holds a total of 579 ANDA approvals (554 final and 25 tentative) as of March 2026.
The approval grants Aurobindo immediate market entry for a large diabetes drug combination with exclusivity protection, potentially boosting US revenue from the generic segment. The $514M market opportunity is significant given Aurobindo's total portfolio size.