Aurobindo Pharma USFDA Dapagliflozin Approval

Aurobindo Pharma received USFDA final approval for Dapagliflozin Tablets, 5 mg and 10 mg, a generic equivalent to AstraZeneca's Farxiga.
The product has an estimated market size of US$10.2 billion for the twelve months ending February 2026 and will be manufactured by subsidiary APL Healthcare.
Aurobindo Pharma is eligible for 180 days of shared generic drug exclusivity as one of the first ANDA applicants with paragraph IV certification.
The company now has 579 ANDA approvals (554 final and 25 tentative) from USFDA as of March 31, 2026.