Alembic Pharma Gets USFDA Nod For Generic Xarelto Tablets

Alembic Pharmaceuticals Ltd. on Thursday said it has received final approval from the US Food and Drug Administration for its abbreviated new drug application for Rivaroxaban tablets USP in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths.

The tablets are a generic version of Janssen Pharmaceuticals Inc.’s Xarelto, the company said in an exchange filing.

Rivaroxaban tablets are used to reduce the risk of major cardiovascular events in patients with coronary artery disease and to cut the risk of major thrombotic vascular events in patients with peripheral artery disease, including those recovering from lower extremity revascularisation.

Alembic said it will launch the 2.5 mg strength in the June quarter. The estimated market size for this strength was around $445 million for the 12 months ended March. The remaining strengths; 10 mg, 15 mg, and 20 mg; had a combined estimated market size of $8.05 billion for the same period, based on IQVIA data.