Alembic Pharmaceuticals Limited announces USFDA Final Approval for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg

15 May, 2025 Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it 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. Refer label for a detailed indication.

According to IQVIA, Rivaroxaban Tablets USP, 2.5 mg, has an estimated market size of US$ 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 US$ 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.