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 estimated market size for remaining strengths of Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg, is $8,052 million for twelve months ending March 2025 according to IQVIA.
The company has a cumulative total of 222 ANDA approvals (198 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
The company’s consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24.