Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Dapagliflozin Tablets in 5 mg and 10 mg strengths, expanding its anti-diabetic portfolio in the highly competitive U.S. generics market.

 

The approved product is bioequivalent and therapeutically equivalent to AstraZeneca’s Farxiga®. 

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 United States.

According to IQVIA MAT data cited by the company, the reference market generated an estimated $10.2 billion in sales for the 12 months ended February 2026, underlining the significant commercial potential of the approval. 

In a key strategic advantage, Aurobindo noted that it was among the first ANDA applicants with a substantially complete Paragraph IV filing, making it eligible for 180 days of shared generic drug exclusivity. This could provide a near-term revenue upside as multiple generic entrants seek to tap the fast-growing SGLT2 inhibitor segment. 

Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, a therapy area that continues to see strong prescription growth globally due to rising diabetes prevalence and expanding cardiometabolic use cases. 

With this latest nod, Aurobindo’s cumulative USFDA tally has reached 579 ANDA approvals, including 554 final and 25 tentative approvals as of March 31, 2026, reinforcing its scale and competitiveness in the U.S. generics market.