Aurobindo Pharma’s Rivaroxaban Tablets get U.S FDA nod

Generic drugmaker Aurobindo Pharma has obtained last approval from the U.S. Meals and Drug Administration (U.S. FDA) to fabricate and market Rivaroxaban Tablets USP, 2.5 mg.

The authorised product is bioequivalent and therapeutically equal to the reference listed drug Xarelto 2.5 mg of Janssen Prescription drugs Inc., the Hyderabad-headquartered firm mentioned on Saturday. 

It plans to launch the product by June. The authorised product had an estimated U.S. market measurement of $447 million for the twelve months ending February 2025, the corporate mentioned citing IQVIA numbers. 

Rivaroxaban Pill USP is used to scale back the chance of stroke and systemic embolism in sufferers with nonvalvular atrial fibrillation; for the therapy of deep vein thrombosis, pulmonary embolism and for the discount within the danger of recurrence of DVT and of PE: and for the prophylaxis of DVT, which can result in PE in sufferers present process knee or hip alternative surgical procedure.

Aurobindo Pharma mentioned it has additionally obtained tentative approval from U.S. FDA for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP. The estimated market measurement of all of the strengths of Rivaroxaban tab USP, in the U.S., was $8.5 billion for the twelve months ended February 2025, based on IQVIA, the corporate mentioned.