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

Dabigatran Etexilate Capsules, are indicated for the reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients, treatment of deep venous thrombosis and pulmonary embolism in adult patients, reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients, prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients following hip replacement surgery. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

According to IQVIA, Dabigatran Etexilate capsules, 75 mg, 110 mg, and 150 mg have an estimated market size of $465 million for twelve months ending December 2021. Alembic Pharmaceuticals has received a cumulative total of 162 ANDA approvals (139 final approvals and 23 tentative approvals) from the US-based drug regulator, USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

On a consolidated basis, the company reported a 39.7% fall in net profit to Rs 176.42 crore on a 3.2% fall in net sales to Rs 1,271.7 crore in Q3 FY22 over Q3 FY21.