Pharma company receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg & tentative approval for other strengths of Rivaroxaban Tablets USP
Aurobindo Pharma Limited announced obtaining the last approval from the US Food & Drug Administration (USFDA) for Rivaroxaban Tablets USP, 2.5 mg.
Aurobindo Pharma Limited announced obtaining the last approval from the US Food & Drug Administration (USFDA) for Rivaroxaban Tablets USP, 2.5 mg. The USFDA granted approval to the product which is bioequivalent and therapeutically equivalent to the reference listed drug XARELTO by Janssen Pharmaceuticals Inc. The product is set to launch in the first quarter of FY26. The market research conducted by IQVIA reveals an approximate value of USD 447 million for Rivaroxaban Tablets USP, 2.5 mg in the US market during the twelve months ending February 2025. Aurobindo Pharma obtained tentative approval for Rivaroxaban Tablets USP in the 10 mg, 15 mg, and 20 mg strengths with an estimated market value of USD 8.5 billion. The USFDA granted 540 ANDA approvals to Aurobindo Pharma where 521 were final and 19 were tentative. Aurobindo Pharma keeps expanding its global presence through the development of generic pharmaceuticals and active pharmaceutical ingredients which it markets in more than 150 nations.
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Aurobindo Pharma functions as one of India’s leading pharmaceutical companies and operates as the second-largest listed pharmaceutical firm by revenue while maintaining its position as the largest generics company in the US market. The company operates across two main business segments: Formulations and Active Pharmaceutical Ingredients (API). Formulations made up 87 per cent of the business in Q3 FY25 while focusing on CNS and Anti-Retroviral CVS therapeutic areas as well as others. The API segment generated 13 per cent of revenue through its strong production of beta-lactams and non-beta-lactams. The company generates revenue mostly from its US operations which account for 53 per cent followed by European markets at 30 per cent and growth markets at 13 per cent.
The company delivers its products to more than 150 nations and maintains operations through 29 manufacturing sites across the world. The commercialization of the Penicillin-G manufacturing facility and boosted R&D expenses which consumed 5.6 per cent of total sales during Q3FY25 mark the company’s recent developments. The biosimilars division alongside niche product development represents Aurobindo Pharma's main focus areas where its 1500 scientists dedicate their efforts.
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