Lupin unveils Rivaroxaban for Oral Suspension in US following USFDA approval

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.

• Treatment of thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.

In addition to the oral suspension approval, Lupin received approval for its ANDAs for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP in May.

Read also: Lupin Rivaroxaban Tablets approved by USFDA

Rivaroxaban for Oral Suspension, 1 mg/mL (RLD Xarelto) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT July 2025).

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.

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