
Lupin has announced the launch of its generic Rivaroxaban for Oral Suspension, 1 mg/mL, in the United States market. This product is bioequivalent to Xarelto® of Janssen Pharmaceuticals, Inc., providing a therapeutically equivalent and safe alternative to the brand-name medicine.
Product Details and Indication
- Product Launched: Rivaroxaban for Oral Suspension, 1 mg/mL (Generic equivalent of Xarelto®).
- Bioequivalence: The Lupin product is bioequivalent, meaning it contains the same active ingredient, strength, and dosage form as the reference drug, and delivers the same therapeutic effect and safety profile.
- Indications (Pediatric Use):
- Treatment of Venous Thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years, following at least 5 days of initial parenteral anticoagulant treatment.
- Thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.
- Market Value: The reference drug, Xarelto® for Oral Suspension, had estimated annual sales of $11 million in the U.S. as of July 2025 (IQVIA MAT).
