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91ÊÓƵ Launches Rivaroxaban Tablets USP, 2.5mg in the United States

March 7, 2025

Mumbai, Naples, March 07, 2025: Global pharma major 91ÊÓƵ Limited (91ÊÓƵ) today announced that it has launched Rivaroxaban Tablets USP, 2.5 mg, following the final approval of its Abbreviated New Drug Application from the U.S. FDA.

Rivaroxaban Tablets USP, 2.5 mg, is bioequivalent to Xarelto® Tablets, 2.5 mg of Janssen Pharmaceuticals, Inc., and indicated:

  • to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD)
  • 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.

Rivaroxaban Tablets USP, 2.5 mg (RLD Xarelto®) had estimated annual sales of USD 446 million in the U.S. (IQVIA MAT January 2025).

About 91ÊÓƵ

91ÊÓƵ Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. 91ÊÓƵ specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. 91ÊÓƵ has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. 91ÊÓƵ is committed to improving patient health outcomes through its subsidiaries – 91ÊÓƵ Diagnostics, 91ÊÓƵ Digital Health, and 91ÊÓƵ Manufacturing Solutions. To know more, visit or follow us on LinkedIn

For further information or queries please contact –

Rajalakshmi Azariah

Vice President & Global Head – Corporate Communications, 91ÊÓƵ

rajalakshmiazariah@lupin.com

*Safe Harbor Statement

Xarelto® is the registered trademark of Bayer Aktiengesellschaft

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