Aurobindo Pharma Receives USFDA Approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
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, 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg. These products will be launched immediately and are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xigduo XR Tablets, of AstraZeneca AB. The approved product has an estimated market size of US$ 514 Million for the twelve months ending February 2026. Aurobindo Pharma, being one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, is eligible for 180 days of shared generic drug exclusivity.
Key Highlights
- Aurobindo Pharma received USFDA approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets.
- The products are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xigduo XR Tablets, of AstraZeneca AB.
- The approved product has an estimated market size of US$ 514 Million for the twelve months ending February 2026.
- Aurobindo Pharma is eligible for 180 days of shared generic drug exclusivity.
- The products will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of the Company.
Price Impact