Latest news with #RivaroxabanTabletsUSP
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 $8,052 million for twelve months ending March 2025 according to IQVIA. The company has a cumulative total of 222 ANDA approvals (198 final approvals and 24 tentative approvals) from USFDA. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24.
Business Standard
15-05-2025
- Business
- Business Standard
Alembic Pharmaceuticals receives USFDA approval for Rivaroxaban Tablets
Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen). Rivaroxaban tablets, 2.5mg, are indicated: i) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD), ii) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD. Refer label for a detailed indication. According to IQVIA, Rivaroxaban Tablets USP, 2.5 mg, has an estimated market size of US$ 445 million for twelve months ending March 2025 and Alembic 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 US$ 8,052 million for twelve months ending March 2025 according to IQVIA.
Business Upturn
15-05-2025
- Business
- Business Upturn
Lupin secures FDA approval for Rivaroxaban 10 mg, 15 mg and 20 mg tablets
By Aman Shukla Published on May 15, 2025, 14:19 IST Lupin Limited has recently informed exchanges that the company received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP in 10 mg, 15 mg, and 20 mg strengths. These tablets are the generic equivalents of Xarelto®, a product developed by Janssen Pharmaceuticals, and have been found bioequivalent to the reference listed drug. The manufacturing of these tablets will take place at Lupin's Aurangabad facility in India. Rivaroxaban is an oral anticoagulant used across multiple indications related to blood clot prevention and treatment. In adults, it is prescribed to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is also used for the treatment and secondary prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as for the prophylaxis of DVT in individuals undergoing knee or hip replacement surgeries. Additionally, it is indicated for preventing venous thromboembolism (VTE) in hospitalized medical patients at risk for thromboembolic complications, provided they are not at high risk of bleeding. In pediatric populations, Rivaroxaban is indicated for the treatment and prevention of recurrent VTE in patients from birth to under 18 years of age. It is also used for thromboprophylaxis in children aged two years and older with congenital heart disease following the Fontan procedure. According to IQVIA MAT data from March 2025, the estimated annual sales of Rivaroxaban Tablets, referencing Xarelto®, in the United States reached approximately USD 8.05 billion. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Business Upturn
15-05-2025
- Business
- Business Upturn
Alembic Pharma gets USFDA nod for Rivaroxaban tablets across four strengths; to launch 2.5 mg in Q1 FY26
By Aditya Bhagchandani Published on May 15, 2025, 13:42 IST Alembic Pharmaceuticals Limited announced on May 15 that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths. These tablets are therapeutically equivalent to Xarelto, a product marketed by Janssen Pharmaceuticals, Inc., and are used to reduce the risk of major cardiovascular and thrombotic vascular events in patients with coronary artery disease (CAD) and peripheral artery disease (PAD). The company plans to launch the 2.5 mg strength in the first quarter of FY26. According to IQVIA, the estimated market size for the 2.5 mg dosage in the U.S. is $445 million for the 12 months ending March 2025, while the market size for the 10 mg, 15 mg, and 20 mg strengths collectively stands at $8,052 million. With this approval, Alembic now holds a cumulative total of 222 ANDA approvals, which includes 198 final approvals and 24 tentative approvals from the USFDA. Alembic Pharmaceuticals, headquartered in Vadodara, India, is a vertically integrated pharmaceutical company engaged in manufacturing and marketing of generic drugs globally. The company has over 5,200 field personnel and a well-established brand presence in the Indian generics market. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
