Lupin has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, to market a generic equivalent of Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India.
Rivaroxaban Tablets USP (RLD Xarelto) had estimated annual sales of $8,249 million in the U.S. (IQVIA MAT November 2023).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
