Lupin Limited has announced the launch of Rivaroxaban for Oral Suspension, 1 mg/mL, in the United States. This medication is a bioequivalent version of Xarelto® for Oral Suspension, 1 mg/mL, originally developed by Janssen Pharmaceuticals, Inc.
The newly launched oral suspension is indicated for the treatment of venous thromboembolism (VTE) and for reducing the risk of recurrent VTE in pediatric patients from birth up to 18 years, after at least five days of initial parenteral anticoagulant therapy. Additionally, it is 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 as of July 2025, the reference listed drug (RLD) Xarelto® for Oral Suspension, 1 mg/mL reported annual U.S. sales of approximately USD 11 million, reflecting significant market potential for Lupin’s new product.
