Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban for Oral Suspension, 1 mg/mL which is bioequivalent to Xarelto for Oral Suspension, 1 mg/mL of Janssen Pharmaceuticals, Inc.

The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India.

Rivaroxaban for Oral Suspension is indicated for treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in paediatric patients from birth to less than 18 years after at least five days of initial parenteral anticoagulant treatment and the treatment of thromboprophylaxis in paediatric patients aged two years and older with congenital heart disease after the Fontan procedure.

As per IQVIA MAT July 2025, Rivaroxaban for Oral Suspension, 1 mg/mL (RLD Xarelto) had estimated annual sales of USD 11 Million in the US.