Aurobindo Pharma Gains USFDA Nod for Diabetes Drug Tablets
Filing Summary
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in various dosages. These tablets are bioequivalent to AstraZeneca’s Xigduo XR. The approved product has an estimated market size of USD 514 million as of February 2026. Aurobindo Pharma, as one of the first ANDA applicants, is eligible for 180 days of shared generic drug exclusivity. The tablets are indicated for improving glycaemic control in adults with type-2 diabetes mellitus.
Aurobindo Pharma Limited has announced the receipt of final approval from the US Food & Drug Administration (USFDA) for the manufacture and marketing of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. The approved dosages include 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg. These tablets are bioequivalent and therapeutically equivalent to the reference listed drug, Xigduo XR Tablets, produced by AstraZeneca AB.
The approved product has an estimated market size of USD 514 million for the twelve months ending February 2026, according to IQVIA MAT. Aurobindo Pharma has a total of 579 ANDA approvals from the USFDA, which includes 554 final approvals and 25 tentative approvals as of March 31, 2026. The company is eligible for 180 days of shared generic drug exclusivity as it was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for these tablets.
The tablets will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of Aurobindo Pharma. The company plans to launch the product immediately. The 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 Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 150 countries. The company operates more than 30 manufacturing and packaging facilities approved by leading regulatory agencies, including the USFDA, UK MHRA, and others.
The approval of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets adds to Aurobindo Pharma’s robust product portfolio, which spans seven major therapeutic areas, including CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic. The company’s strong R&D setup supports its diverse product offerings.
Aurobindo Pharma Limited continues to focus on expanding its product portfolio and strengthening its presence in the global pharmaceutical market. The company aims to leverage its manufacturing capabilities and regulatory approvals to enhance its market position in the generic drug industry.