By: IPP Bureau
Last updated : March 07, 2025 9:12 pm
Rivaroxaban Tablets USP, 2.5 mg, is bioequivalent to Xarelto® Tablets, 2.5 mg of Janssen Pharmaceuticals
Global pharma major Lupin Limited (Lupin) today announced that it has launched Rivaroxaban Tablets USP, 2.5 mg, following the final approval of its Abbreviated New Drug Application from the USFDA.
Rivaroxaban Tablets USP, 2.5 mg, is bioequivalent to Xarelto® Tablets, 2.5 mg of Janssen Pharmaceuticals and indicated:
- to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD)
- to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD.
Rivaroxaban Tablets USP, 2.5 mg (RLD Xarelto®) had estimated annual sales of USD 446 million in the U.S. (IQVIA MAT January 2025).