Aurobindo Pharma gets USFDA nod for Rivaroxaban tablets

Aurobindo Pharma said that it has received final approval from US Food and Drug Administration (USFDA) to manufacture and market Rivaroxaban Tablets USP, 2.5 mg.

The said drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), XARELTO, 2.5 mg of Janssen Pharmaceuticals Inc. Rivaroxaban Tablet USP is used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and of PE, for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

Rivaroxaban Tablets USP, 2.5mg, has an estimated US market size of $447 million for the twelve months ending February 2025, according to IQVIA. The company now has a total of 540 ANDA approvals (521 Final approvals and 19 tentative approvals) from USFDA.

The company has also received tentative approval from USFDA for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP. The estimated market size of all the strengths of Rivaroxaban tablets USP, in the US, is $8.5 billion for the twelve months ending February 2025, according to IQVIA.

Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.

The companys consolidated net profit fell 9.7% to Rs 845.81 crore in Q3 FY25 as compared with Rs 936.26 crore in Q3 FY24. Net sales increased 8.6% YoY to Rs 7,893.15 crore during the quarter ended 31st December 2024.

The scrip added 2.47% to end at Rs 1,082.55 on Friday, 11 April 2025. The stock market will remain closed today on account of Dr. Babasaheb Ambedkar Jayanti.

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