RIVAROXABAN MARKET ANALYSIS

Key Developments

• In April 2024, Johnson & Johnson announced new data from the PIONEER AF-PCI clinical trial, showing that XARELTO (rivaroxaban) reduced the risk of clinically significant bleeding (CSB) and net adverse clinical events (NACE) compared to warfarin in both elderly and non-elderly patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). These findings were presented at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) in Atlanta, Georgia.
• In January 2024, Lupin secured tentative approval from the U.S. Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP in 2.5 mg, 10 mg, 15 mg, and 20 mg doses. This approval allows Lupin to market a generic version of Xarelto Tablets, in the same strengths, originally developed by Janssen Pharmaceuticals. The product will be manufactured at Lupin’s Pithampur facility in India.
• In February 2024, Roche launched three new coagulation tests for the oral Factor Xa inhibitors apixaban, edoxaban, and rivaroxaban in countries accepting the CE mark. These tests, aimed at improving clinical decision-making for patients treated with these anticoagulants, are crucial for conditions like non-valvular atrial fibrillation, CAD, PAD, and VTE.