Alembic secures FDA approval for generic Pradaxa

Alembic has received the Food and Drug Administration’s permission for Dabigatran Etexilate Capsules, 75 mg and 150 mg and tentative approval for Dabigatran Etexilate Capsules, 110 mg. 

The approved drug is the generic of Boehringer Ingelheim’s Pradaxa. 

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. 

[Read more: Alembic intros generic Perforomist]

Dabigatran Etexilate Capsules 75 mg and 150 mg have a market value of roughly $179 million for the 12 months ending March 2024, and Dabigatran Etexilate Capsules 110 mg have a market value of roughly $5 million for the same period, per IQVIA.

[Read more: Alembic unveils 2 generics]