Alembic Pharma gets USFDA nod for Dabigatran Etexilate capsules

Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic Dabigatran Etexilate capsules 75 mg and 150 mg used to reduce risk of stroke and blood clots in adults with a certain medical condition. The US Food & Drug Administration (USFDA) has also granted tentative approval for the Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate capsules 110 mg, Alembic Pharmaceuticals, said in a statement.

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, Inc. (Boehringer), it added.

The Dabigatran Etexilate capsules are indicated for the reduction of risk of stroke and systemic embolism in adults who have a medical condition called atrial fibrillation that is not caused by a heart valve problem.

It is also used in the treatment and reduction of the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients.

Alembic Pharma said Dabigatran Etexilate capsules 75 mg and 150 mg have an estimated market size of USD 179 million for 12 months ended March 2024 citing IQVIA data.

On the other hand, Dabigatran Etexilate Capsules 110 mg have an estimated market size of USD 5 million for 12 months ended March 2024, it added.