Alembic Pharmaceuticals Receives USFDA Final Approval for Rivaroxaban Tablets

Alembic Pharmaceuticals Ltd has received US Food & Drug Administration (USFDA) Final Approval for 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. Rivaroxaban tablets, 2.5mg, are indicated to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) and to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD). According to IQVIA, Rivaroxaban Tablets USP, 2.5 mg, has an estimated market size of USS 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 USS 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.