FDA approves first generic of Xarelto

The US Food and Drug Administration (FDA) has approved the first generics of Xarelto (rivaroxaban), a cardio vascular drug developed by Germany’s Bayer (BAYN: DE) and marketed in the USA by Johnson & Johnson (NYSE: JNJ).

Awarded to Taro Pharmaceuticals Industries, a subsidiary of Indian generics major Sun Pharma (BSE: 524715), this generic approval is targeted to reduce the risk of major cardiovascular events in adult patients with coronary artery disease (CAD) and 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.

Bayer recorded 2024 global sales for Xarelto of 3.48 billion euros ($3.78 billion).