Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets, 5 mg and 10 mg. This approval marks a significant milestone for Alembic as it positions itself within a lucrative market segment.
The approved Dapagliflozin Tablets are therapeutically equivalent to the reference listed drug product, Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It is indicated for reducing the risk of hospitalisation for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. Additionally, it serves as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Alembic was among the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets. Consequently, with this approval, Alembic is eligible for 180 days of shared generic drug exclusivity, providing a competitive edge in the market.
The market size for Dapagliflozin tablets, 5 mg and 10 mg, is estimated at US$ 10,487 million for the twelve months ending December 2025, according to IQVIA. This substantial market size underscores the potential revenue opportunities for Alembic.
Alembic Pharmaceuticals has a cumulative total of 235 ANDA approvals from the USFDA, which includes 217 final approvals and 18 tentative approvals. This latest approval further strengthens Alembic’s position as a key player in the pharmaceutical industry.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).