Alembic Pharma Secures USFDA Approval for Dapagliflozin Tablets, Gains 180-Day Exclusivity

Diabetes and heart failure drug targets $10.4 billion US market

Mumbai: Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets in 5 mg and 10 mg strengths.

The approved drug is therapeutically equivalent to AstraZeneca’s reference product Farxiga and is indicated for the treatment of type 2 diabetes and reduction in risk of hospitalization due to heart failure. The medication belongs to the SGLT2 inhibitor class and is used to improve glycaemic control alongside diet and exercise.

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

The approval positions the company to tap into a significant market opportunity, with Dapagliflozin tablets recording an estimated annual market size of $10.4 billion in the United States for the 12 months ending December 2025.

The drug plays a critical role in managing type 2 diabetes, particularly among patients with cardiovascular risk factors, while also addressing heart failure-related complications—making it a key therapeutic option in chronic disease management.

With this latest approval, Alembic’s cumulative tally of USFDA approvals has reached 235, including 217 final approvals and 18 tentative approvals, underscoring its strong presence in the regulated generics market.

The development reflects Alembic’s continued focus on expanding its global generics portfolio and strengthening its position in high-value therapeutic segments.

Headquartered in India, Alembic Pharmaceuticals is a vertically integrated research-driven company with a long-standing presence in global pharmaceutical markets, supported by USFDA-approved manufacturing and research facilities.