Mumbai, Naples, March 07, 2025: Global pharma major Lupin Limited (Lupin) 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 Lupin Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin 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. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

For further information or queries please contact –

Rajalakshmi Azariah Vice President & Global Head – Corporate Communications, Lupin rajalakshmiazariah@lupin.com

*Safe Harbor Statement Xarelto® is the registered trademark of Bayer Aktiengesellschaft