Lupin Launches Rivaroxaban Tablets USP, 2.5mg in the US with FDA Approval

Global pharma major Lupin Limited has announced the launch of Rivaroxaban Tablets USP, 2.5 mg, in the United States. The launch follows the final approval from the U.S. FDA for the company’s Abbreviated New Drug Application. Rivaroxaban Tablets USP, 2.5 mg, is bioequivalent to Xarelto® Tablets, 2.5 mg, of Janssen Pharmaceuticals, Inc., and indicated for reducing the risk of major cardiovascular events in patients with coronary artery disease (CAD) and reducing the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD). The estimated annual sales of Rivaroxaban Tablets USP, 2.5 mg, in the U.S. are USD 446 million (IQVIA MAT January 2025).