Leading pharmaceutical company Lupin has officially introduced its generic version of Rivaroxaban for Oral Suspension, 1 mg/mL, into the competitive United States market. This marks an important step in making essential medication more accessible.
The newly launched product is a bioequivalent alternative to Xarelto for Oral Suspension, 1 mg/mL, originally developed by Janssen Pharmaceuticals, Inc. According to IQVIA MAT data from July 2025, the reference listed drug, Xarelto, previously generated an estimated annual sales of $11 million in the U.S. market, highlighting the significant demand for this therapeutic option.
Rivaroxaban for Oral Suspension is specifically indicated for two primary uses. Firstly, it’s prescribed for the comprehensive treatment of venous thromboembolism (VTE) and for significantly reducing the risk of recurrent VTE in pediatric patients, ranging from newborns to those under 18 years of age. This treatment is typically administered after at least five days of initial parenteral anticoagulant therapy. Secondly, it plays a crucial role in thromboprophylaxis, preventing blood clot formation in pediatric patients two years and older who have congenital heart disease and have undergone the complex Fontan procedure.