Lupin Limited announced it has received approval from the U.S. FDA for its Abbreviated New Drug Application for Rivaroxaban for Oral Suspension, 1 mg/mL. This product is bioequivalent to Xarelto® for Oral Suspension, 1 mg/mL. The manufacturing will take place at Lupin’s Chhatrapati Sambhajinagar facility in India. This approval strengthens Lupin’s portfolio and its presence in the U.S. market.
FDA Approval for Rivaroxaban
Lupin Limited (Lupin) announced today, September 30, 2025, that it has secured approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban for Oral Suspension, 1 mg/mL. This product is a bioequivalent to Xarelto® for Oral Suspension, 1 mg/mL, developed by Janssen Pharmaceuticals, Inc. Lupin will manufacture the product at its Chhatrapati Sambhajinagar facility in India.
Indications for Rivaroxaban
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.
- Treatment of thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.
Market Potential
Rivaroxaban for Oral Suspension, 1 mg/mL (RLD Xarelto®) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT July 2025).
Source: BSE