Aurobindo Pharma Secures USFDA Nod for Dapagliflozin-Metformin XR, Gains 180-Day Exclusivity
New Delhi: Aurobindo Pharma Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in multiple strengths, the company announced.
The approved strengths include 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 the reference listed drug Xigduo XR Tablets of AstraZeneca AB.
According to the company, the approved formulation will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of Aurobindo Pharma, and the product launch is planned immediately.
Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
Aurobindo Pharma stated that it was among the first applicants to file a substantially complete ANDA with a paragraph IV certification for this product. With this approval, the company will be eligible for 180 days of shared generic drug exclusivity in the US market.
The company highlighted that the approved product has an estimated market size of approximately US$ 514 million for the twelve months ending February 2026, as per IQVIA data.
With this latest approval, Aurobindo Pharma has further expanded its US generics portfolio. As of March 31, 2026, the company has received a total of 579 ANDA approvals from the USFDA, including 554 final approvals and 25 tentative approvals.
Aurobindo Pharma Limited, headquartered in Hyderabad, is an integrated global pharmaceutical company with operations in over 150 countries. The company develops, manufactures, and markets a wide range of generic pharmaceuticals, specialty products, and active pharmaceutical ingredients. It operates more than 30 manufacturing and packaging facilities approved by major global regulatory authorities including the USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA.
