Aurobindo Pharma’s Rivaroxaban Tablets get U.S FDA nod-OxBig News Network

Generic drugmaker Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Rivaroxaban Tablets USP, 2.5 mg.

The approved product is bioequivalent and therapeutically equivalent to the reference listed drug Xarelto 2.5 mg of Janssen Pharmaceuticals Inc., the Hyderabad-headquartered company said on Saturday. 

It plans to launch the product by June. The approved product had an estimated U.S. market size of $447 million for the twelve months ending February 2025, the company said citing IQVIA numbers. 

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

Aurobindo Pharma said it has also received tentative approval from U.S. FDA for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP. The estimated market size of all the strengths of Rivaroxaban tab USP, in the U.S., was $8.5 billion for the twelve months ended February 2025, according to IQVIA, the company said.