Global pharmaceutical major Lupin Limited has announced the launch of Rivaroxaban for Oral Suspension, 1 mg/mL, in the United States, further expanding its presence in the high-value U.S. generics market.

The newly launched product is bioequivalent to Janssen Pharmaceuticals Inc.’s Xarelto® Oral Suspension (1 mg/mL) and is approved for pediatric use in specific conditions.

According to the company, Rivaroxaban Oral Suspension is indicated for the treatment of venous thromboembolism (VTE) and for reducing the risk of recurrent VTE in pediatric patients from birth to under 18 years of age, following at least five days of initial anticoagulant therapy. It is also approved for thromboprophylaxis in pediatric patients aged two years and above with congenital heart disease who have undergone the Fontan procedure.

Industry data highlights the significance of the launch. The reference drug, Xarelto® Oral Suspension, recorded estimated annual sales of USD 11 million in the U.S. market (IQVIA MAT July 2025).

The launch marks another milestone for Lupin in strengthening its global portfolio, particularly in the pediatric anticoagulant segment, which remains an important therapeutic area in the US.