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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About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit , Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information References Wharton, S, et al. (2025). Once-weekly semaglutide 7.2 mg in adults with obesity: the randomised, controlled, phase 3b STEP UP trial. 1966-LB poster. American Diabetes Association (ADA) 85th Scientific Sessions, Chicago, US, June 20 – 23, 2025.17. Attachment Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
