- Alembic Pharmaceuticals Limited secures final USFDA approval for key diabetes therapy
- Generic version of Farxiga opens door to 180-day exclusivity advantage
- Entry into $10.4 billion market strengthens global generics footprint
NE BUSINESS BUREAU
MUMBAI, APR 7
Alembic Pharmaceuticals Limited on Tuesday announced that it has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets in strengths of 5 mg and 10 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB.
Dapagliflozin tablets belong to the sodium-glucose cotransporter 2 (SGLT2) inhibitor class and are indicated: i) to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, and ii) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Refer label for detailed indication.
Alembic was among the first ANDA applicants to submit a substantially complete application with a paragraph IV certification for Dapagliflozin Tablets, 5 mg and 10 mg. With this approval, the company becomes eligible for 180 days of shared generic drug exclusivity in the US market.
According to IQVIA data, Dapagliflozin tablets, 5 mg and 10 mg, have an estimated market size of US$ 10,487 million for the twelve months ending December 2025, underscoring the significant commercial opportunity.
With this, Alembic’s cumulative tally of ANDA approvals from the USFDA has reached 235, including 217 final approvals and 18 tentative approvals, reinforcing its strong presence in the regulated generics space.
