Mumbai, May 15 -- The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen).

Rivaroxaban tablets, 2.5mg, are indicated to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) and 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.

According to IQVIA, Rivaroxaban Tablets USP, 2.5 mg, has an estimated market size of $445 million for twelve months ending March 2025 and the company will be launching this strength in Q1FY26. The estimat...