Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated April 07, 2026, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Dapagliflozin Tablets, 5 mg and 10 mg.".
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Alembic Pharmaceuticals has received final approval from the USFDA for its generic Dapagliflozin Tablets in 5 mg and 10 mg dosages. The drug is therapeutically equivalent to AstraZeneca's Farxiga and is an SGLT2 inhibitor used to reduce heart failure hospitalization risk in adults with type 2 diabetes and to improve blood sugar control. The US market for this product is estimated at $10,487 million. As one of the first ANDA applicants with a paragraph IV certification, Alembic qualifies for 180 days of shared generic drug exclusivity. This approval brings Alembic's total USFDA ANDA approvals to 235 (217 final and 18 tentative).
This approval gives Alembic entry into a large $10+ billion US market with 180 days of potential exclusivity, which could boost revenue from US generic sales. Thedapagliflozin market is substantial, making this a meaningful product launch for the company.