Aurobindo Pharma gets USFDA final, tentative nod for different strengths of deep vein thrombosis drug Rivaroxaban

Aurobindo Pharma Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market RivaroxabanTablets USP, 2.5 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), XARELTO, 2.5 mg of Janssen Pharmaceuticals Inc.

Rivaroxaban Tablet USP is used (i) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (ii) for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and of PE (iii) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

 The product will be launched in Q1FY26.

The approved product, Rivaroxaban Tablets USP, 2.5mg, has an estimated US market size of US$ 447 million for the twelve months ending February 2025, according to IQVIA. Aurobindo Pharma now has a total of 540 ANDA approvals (521 Final approvals and 19 tentative approvals) from USFDA.

Aurobindo Pharma also received tentative approval from USFDA for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP. The estimated market size of all the strengths of Rivaroxaban tablets USP, in the US, is US$ 8.5 billion for the twelve months ending February 2025, according to IQVIA.