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Lupin receives USFDA's approval for Rivaroxaban for Oral Suspension

01 Oct 2025 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application 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 the company'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 pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment; and for treatment of thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure. Rivaroxaban for Oral Suspension, 1 mg/mL (RLD Xarelto) had estimated annual sales of $11 million in the U.S. (IQVIA MAT July 2025).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

Lupin Share Price

2377.90 -81.85 (-3.33%)
08-May-2026 16:59 View Price Chart
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