USFDA Approves Alembic's Dapagliflozin Tablets, Grants 180-Day Exclusivity
New Delhi: Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Dapagliflozin Tablets in strengths of 5 mg and 10 mg, the company announced in a regulatory filing.
The approval has been granted for Alembic’s Abbreviated New Drug Application (ANDA), with the product being therapeutically equivalent to the reference listed drug Farxiga Tablets, 5 mg and 10 mg, developed by AstraZeneca AB.
Dapagliflozin belongs to the class of sodium-glucose cotransporter 2 (SGLT2) inhibitors. It is indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. Additionally, it is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Alembic highlighted that it was among the first applicants to submit a substantially complete ANDA with a paragraph IV certification for this product. With the final approval, the company is now eligible for 180 days of shared generic drug exclusivity in the US market.
According to IQVIA data, Dapagliflozin tablets in the approved strengths have an estimated market size of US$ 10,487 million for the twelve months ending December 2025, indicating a significant commercial opportunity for the company.
With this latest approval, Alembic Pharmaceuticals has further strengthened its US generics portfolio. The company now has a cumulative total of 235 ANDA approvals from the USFDA, comprising 217 final approvals and 18 tentative approvals.
Alembic Pharmaceuticals Limited, headquartered in Vadodara, is a vertically integrated research and development-driven pharmaceutical company with a legacy dating back to 1907. The company manufactures and markets generic pharmaceutical products globally and operates state-of-the-art facilities approved by several international regulatory authorities, including the USFDA.
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