Lupin Launches Rivaroxaban for Oral Suspension in the United States
Mumbai, Naples, October 1, 2025: Global pharma major Lupin Limited (Lupin) today announced the launch of Rivaroxaban for Oral Suspension, 1 mg/mL, in the United States. Rivaroxaban for Oral Suspension, 1 mg/mL is bioequivalent to Xarelto® for Oral Suspension, 1 mg/mL of Janssen Pharmaceuticals, Inc.
Rivaroxaban for Oral Suspension is indicated for:
- Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.
- Treatment of thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.
Rivaroxaban for Oral Suspension, 1 mg/mL (RLD Xarelto®) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT July 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 24,000 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
Latest Press Releases
Lupin Receives Tentative Approval from U.S. FDA for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets
Lupin Announces Closure of Inspection by U.S. FDA at its Somerset Facility with No Observations
Lupin Receives Approval from U.S. FDA for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06%
Close
Global Privacy Control Detected
We have detected your Global Privacy Control (GPC) signal. In accordance with applicable privacy laws, we have automatically honored your preference and disabled all non-essential cookies and tracking.
Only necessary cookies required for the website to function are enabled.
Opt-Out Request Honored
We have respected your privacy preference. Your opt-out request through cookie settings or Global Privacy Control signal has been honored.