Lupin Rivaroxaban Tablets approved by USFDA

Mumbai: Global pharma major Lupin Limited has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg.

Rivaroxaban Tablets are bioequivalent to Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals.

This product will be manufactured at Lupin’s Aurangabad facility in India.

Rivaroxaban Tablets USP are indicated:

• to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation

• for treatment of deep vein thrombosis (DVT)

• for treatment of pulmonary embolism (PE)

• for reduction in the risk of recurrence of DVT and/or PE

• for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery

• for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding

• for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years

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

Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg (RLD Xarelto) had estimated annual sales of USD 8,052 million in the U.S. (IQVIA MAT March 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.