Latest news with #RivaroxabanTablets
The Hindu
15-05-2025
- Business
- The Hindu
U.S. FDA nod for Lupin's generic of Janssen Pharma's blood thinner tablets
Drugmaker Lupin has received U.S. Food and Drug Administration (U.S. FDA) approval for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg, its generic version of Janssen Pharmaceuticals' blood thinner tablet Xarelto. The product will be manufactured at its Aurangabad facility. The approved product had an estimated annual sales of $8,052 million in the U.S., Lupin said citing IQVIA MAT March 2025 numbers. Rivaroxaban Tablets USP are indicated to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation and for treatment of deep vein thrombosis as well as pulmonary embolism, it said. Rivaroxaban Tablets are bioequivalent to Xarelto, which Jannsen said is a blood thinner to treat and help prevent blood clots related to certain conditions involving the heart and blood vessels.
Business Standard
15-05-2025
- Business
- Business Standard
Alembic Pharma rises on USFDA approval for Rivaroxaban Tablets
Alembic Pharmaceuticals advanced 1.10% to Rs 918.15 after the company received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Rivaroxaban Tablets. 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 companys 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.
Business Standard
15-05-2025
- Business
- Business Standard
Lupin receives USFDA approval for Rivaroxaban Tablets
Lupin announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg. Rivaroxaban Tablets are bioequivalent to Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals. This product will be manufactured at Lupin's Aurangabad facility in India.
