Lupin secures FDA approval for Rivaroxaban 10 mg, 15 mg and 20 mg tablets
By Aman Shukla Published on May 15, 2025, 14:19 IST
Lupin Limited has recently informed exchanges that the company received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP in 10 mg, 15 mg, and 20 mg strengths. These tablets are the generic equivalents of Xarelto®, a product developed by Janssen Pharmaceuticals, and have been found bioequivalent to the reference listed drug. The manufacturing of these tablets will take place at Lupin's Aurangabad facility in India.
Rivaroxaban is an oral anticoagulant used across multiple indications related to blood clot prevention and treatment. In adults, it is prescribed to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is also used for the treatment and secondary prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as for the prophylaxis of DVT in individuals undergoing knee or hip replacement surgeries. Additionally, it is indicated for preventing venous thromboembolism (VTE) in hospitalized medical patients at risk for thromboembolic complications, provided they are not at high risk of bleeding.
In pediatric populations, Rivaroxaban is indicated for the treatment and prevention of recurrent VTE in patients from birth to under 18 years of age. It is also used for thromboprophylaxis in children aged two years and older with congenital heart disease following the Fontan procedure.
According to IQVIA MAT data from March 2025, the estimated annual sales of Rivaroxaban Tablets, referencing Xarelto®, in the United States reached approximately USD 8.05 billion.
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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