Aurobindo Pharma has received final approval from the USFDA to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. This drug, used to improve glycaemic control in adults with type-2 diabetes mellitus, targets a market size of US$ 514 million for the twelve months ending February 2026. The company is also eligible for 180 days of shared generic drug exclusivity for this product.
Strategic Product Expansion
Aurobindo Pharma Limited has announced the receipt of final approval from the U.S. Food and Drug Administration (USFDA) for its Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. The approved drug is available in four dosage strengths: 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, produced by AstraZeneca AB.
Market Opportunity and Exclusivity
The product addresses a significant market, with an estimated size of US$ 514 million for the twelve months ending February 2026. As one of the initial applicants to submit a substantially complete Abbreviated New Drug Application (ANDA) featuring a paragraph IV certification, Aurobindo Pharma has been granted 180 days of shared generic drug exclusivity. This launch is expected to be immediate, utilizing the company’s Unit-IV facility under its subsidiary, APL Healthcare Limited.
Portfolio Growth
This latest regulatory milestone brings Aurobindo Pharma’s total USFDA approvals to 579, which includes 554 final approvals and 25 tentative approvals as of March 31, 2026. The company remains focused on strengthening its global presence across seven major therapeutic areas, including anti-diabetics, supported by its extensive network of over 30 manufacturing facilities worldwide.
Source: BSE
