Taro Pharmaceuticals and Lupin have received U.S. FDA approvals for generic versions of Bayer’s Xarelto (rivaroxaban) 2.5 mg tablets — the first generic competitors to the blockbuster cardiovascular drug marketed by Johnson & Johnson in the U.S.
The 2.5 mg generic rivaroxaban tablets were approved to reduce the risk of major cardiovascular events in adult patients with coronary artery disease (CAD) and to reduce the risk of major thrombotic vascular events in adult patients with peripheral artery disease (PAD), including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.
India-based Lupin reported that has launched its tablets, which are bioequivalent to Xarelto, onto the U.S. market. Taro, a subsidiary of Indian generics major Sun Pharma, has not reported a launch date for its tablets.
Xarelto, first approved in the U.S. in 2011, is a factor Xa inhibitor used to lower the risk of blood clots, strokes and deep vein thrombosis. The drug, which has a list price of over $600 for a 30-day supply, was one of the first ten drugs chosen by the Centers for Medicare & Medicaid Services for Medicare price negotiations in accordance with the Inflation Reduction Act (IRA).