Lupin launches Rivaroxaban for Oral Suspension, 1 mg/mL, in the United States, which is bioequivalent to Xarelto of Janssen Pharmaceuticals, Inc.
A bioequivalent medicine is a drug that contains the same active ingredient, in the same strength and dosage form, as an already approved brand-name (reference) medicine and shows no significant difference in the rate and extent of absorption in the body. In simpler terms, a bioequivalent medicine works the same way, provides the same therapeutic effect, and is just as safe and effective as the original branded product, but it may differ in inactive ingredients like color, shape, or preservatives.
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. It is also approved for treatment of thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.
Rivaroxaban for Oral Suspension, 1 mg/mL (RLD Xarelto®) had estimated annual sales of USD 11 million in the U.S. as per IQVIA MAT July 2025.
