Mumbai, April 7 -- The approved drug is therapeutically equivalent to AstraZeneca's reference listed drug (RLD), Farxiga. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and to improve glycaemic control.

Alembic said it was among the first applicants to file a substantially complete ANDA with a paragraph IV certification for the drug, making it eligible for 180 days of shared generic drug exclusivity.

According to IQVIA, the Dapagliflozin tablets market had an estimated size of $10.49 billion for the 12 months ended December 2025.

The company now has a cumulative total of 235 ANDA approvals from the USFDA, including 217 final...