Alembic Pharmaceuticals gets USFDA’s final nod for Rivaroxaban Tablets USP

15 May 2025 Evaluate

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen).

Rivaroxaban tablets, 2.5mg, are indicated: i) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD), ii) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD.  According to IQVIA, Rivaroxaban Tablets USP, 2.5 mg, has an estimated market size of $445 million for twelve months ending March 2025 and Alembic will be launching this strength in Q1FY26.

The estimated market size for remaining strengths of Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg, is $8,052 million for twelve months ending March 2025 according to IQVIA. Alembic has a cumulative total of 222 ANDA approvals (198 final approvals and 24 tentative approvals) from USFDA. 

Alembic Pharmaceuticals is principally engaged in the manufacturing and selling of pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.

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