Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in four 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 Xigduo XR. 

The company said the product will be manufactured at Unit-IV of APL Healthcare Ltd, its wholly owned subsidiary, and is slated for an immediate launch in the U.S. market. According to IQVIA MAT data cited by the company, the reference product recorded an estimated US$514 million market size for the 12 months ended February 2026, indicating a meaningful near-term revenue opportunity. 

Importantly, Aurobindo is among the first ANDA applicants with a substantially complete Paragraph IV filing, making it eligible for 180 days of shared generic drug exclusivity. This exclusivity window could offer an early-mover advantage in the growing type-2 diabetes combination therapy segment. 

The therapy is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus where dual treatment with dapagliflozin and metformin is appropriate.

With this approval, Aurobindo’s cumulative USFDA tally now stands at 579 ANDA approvals, including 554 final and 25 tentative approvals as of March 31, 2026.