Alembic Pharma Secures Major Win with U.S. FDA Approval for Dabigatran Etexilate Capsules

Alembic Pharmaceuticals has issued a statement that it has received final approval from the USFDA i.e., US Food & Drug Administration for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules in 75 mg and 150 mg dosages, as well as tentative approval for the 110 mg dosage of the same capsules.

The approved ANDA matches the therapeutic effects of the reference drug product Pradaxa Capsules (75 mg, 110 mg, and 150 mg) by Boehringer Ingelheim Pharmaceuticals. Dabigatran Etexilate Capsules are prescribed to lower the risk of stroke and systemic embolism in adults with non-valvular atrial fibrillation, as well as to treat and prevent the recurrence of deep vein thrombosis and pulmonary embolism in adults.

Dabigatran Etexilate Capsules in 75 mg and 150 mg dosages are projected to have a market value of approximately USD 179 million for the 12-month period ending in March 2024, as reported by IQVIA. The 110 mg dosage is estimated to have a market value of around USD 5 million for the same period. Alembic has received a total of 205 ANDA approvals from the USFDA, which includes 178 final approvals and 27 tentative approvals.