New Delhi: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapagliflozin Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB (AstraZeneca). Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: i) to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, and ii) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Refer label for a detailed indication.
Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets, 5 mg and 10 mg. Therefore, with this approval, Alembic is eligible for 180 days of shared generic drug exclusivity.
Dapagliflozin tablets, 5 mg and 10 mg, have an estimated market size of US$ 10,487 million for twelve months ending December 2025 according to IQVIA.
Alembic has a cumulative total of 235 ANDA approvals (217 final approvals and 18 tentative approvals) from USFDA.
