Lupin receives USFDA nod for Rivaroxaban Oral Suspension

Lupin announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban for Oral Suspension, 1 mg/mL.

The product is a generic version of Xarelto for Oral Suspension, 1 mg/mL, originally developed by Janssen Pharmaceuticals, Inc.

The approved product is bioequivalent to the reference listed drug and will be manufactured at Lupin?s facility in Chhatrapati Sambhajinagar, India.

Rivaroxaban for Oral Suspension is indicated for the treatment of venous thromboembolism (VTE) and for reducing the risk of recurrent VTE in pediatric patients from birth to less than 18 years of age, following at least five days of initial parenteral anticoagulant therapy. It is also approved for thromboprophylaxis in pediatric patients aged two years and older with congenital heart disease who have undergone the Fontan procedure.

According to IQVIA MAT data for July 2025, Rivaroxaban for Oral Suspension, 1 mg/mL (RLD Xarelto), recorded estimated annual sales of approximately $11 million in the United States.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The company's consolidated net profit jumped 52.13% to Rs 1,219.03 crore on an 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25.

The counter declined 1.09% to Rs 1910.15 on the BSE.

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