Global pharmaceutical company Lupin Limited today confirmed the launch of Rivaroxaban Tablets USP, 2.5 mg, in the U.S., post the final FDA approval of its abbreviated new drug application.
This generic alternative to Xarelto® 2.5 mg by Janssen is approved for:
- Lowering the likelihood of major cardiovascular episodes in patients with coronary artery disease (CAD)
- Helping prevent severe vascular thrombotic events in those with peripheral artery disease (PAD), especially following lower limb revascularization procedures.
Sales of the reference drug in the U.S. reached $446 million annually according to IQVIA MAT, January 2025.
Company Profile: Lupin
Based in Mumbai, Lupin Limited is a globally recognized pharmaceutical company with a footprint in over 100 countries. The company specializes in branded and generic medicines, biosimilars, APIs, and advanced generics. With strong presences in India and the U.S., Lupin covers a wide range of therapeutic areas such as cardiology, respiratory care, infectious diseases, gastrointestinal, neurology, diabetes, and women’s health. It operates 15 manufacturing plants, 7 R&D centers, and employs 23,000+ people. Subsidiaries like Lupin Diagnostics and Lupin Digital Health support its commitment to innovation and patient health. Visit www.lupin.com or find us on LinkedIn.
Note: Xarelto® is a registered trademark of Bayer Aktiengesellschaft
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