Zheng Quan Zhi Xing·2025-05-20 09:12Group 1 - Shanghai Pharmaceuticals has received FDA approval for its abbreviated new drug application (ANDA) for rivaroxaban tablets [1] - The drug is indicated for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treating and preventing deep vein thrombosis (DVT), treating pulmonary embolism (PE), and preventing venous thromboembolism (VTE) in acutely ill patients [1][2] - The company has invested approximately RMB 8.2 million in research and development for this drug [1] Group 2 - The market competition for rivaroxaban tablets in the U.S. includes the original developer Janssen Pharmaceuticals and generic manufacturers such as Apotex, Aurobindo Pharma, Lupin, Dr. Reddy's Laboratories, and Macleods Pharmaceuticals [2] - Rivaroxaban tablets generated approximately $8.13 billion in sales in the U.S. in 2023, with projected sales of about $6.33 billion for the first three quarters of 2024 [2] - The approval of the ANDA is expected to positively impact the company's expansion into overseas markets [2]