Alembic Pharma announces U.S. FDA approval for Dabigatran Etexilate Capsules, 75 mg and 150 mg and tentative approval for Dabigatran Etexilate Capsules, 110 mg

Alembic Pharmaceuticals  (Alembic) has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg and 150 mg and Tentative approval for Dabigatran Etexilate Capsules, 110 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim Pharmaceuticals, (Boehringer).

Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients; treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients. 

Dabigatran Etexilate Capsules 75 mg and 150 mg have an estimated market size of USD 179 million for 12 months ending March 2024 according to IQVIA. Dabigatran Etexilate Capsules 110 mg have an estimated market size of USD 5 million for 12 months ending March 2024 according to IQVIA.

Alembic has a cumulative total of 205 ANDA approvals (178 final approvals and 27 tentative approvals) from USFDA.