Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, to market a generic equivalent of Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India.

Rivaroxaban Tablets USP are indicated to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation, for treatment of deep vein thrombosis (DVT), for treatment of pulmonary embolism (PE), for reduction in the risk of recurrence of DVT or PE, for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery and for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients etc.

Rivaroxaban Tablets USP (RLD Xarelto) had estimated annual sales of USD 8,249 million in the U.S. (IQVIA MAT November 2023).