Lupin Ltd. shares rose over 3% in early trade after the company announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Oral Suspension, 1 mg/mL. This pediatric formulation is bioequivalent to Xarelto® Oral Suspension, marketed by Janssen Pharmaceuticals, and will be produced at Lupin’s Chhatrapati Sambhajinagar facility in India.
Rivaroxaban Oral Suspension is approved for the treatment of venous thromboembolism (VTE) and to reduce the risk of recurrent VTE in children from birth to under 18 years, following at least five days of initial parenteral anticoagulant therapy. It is also indicated for thromboprophylaxis in pediatric patients aged two years and above with congenital heart disease after a Fontan procedure.
The U.S. market opportunity is meaningful, with Xarelto® Oral Suspension estimated to generate around USD 11 million in annual sales (IQVIA MAT, July 2025). This approval not only expands Lupin’s pediatric portfolio but also reinforces its footprint in the highly regulated U.S. pharmaceutical market.