Lupin Limited has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for rivaroxaban tablets USP in strengths of 10 mg, 15 mg, and 20 mg. The product is a generic version of Xarelto by Janssen Pharmaceuticals and will be manufactured at Lupin’s Chhatrapati Sambhajinagar (Aurangabad) facility in India.

Key highlights

Indications and therapeutic use

• Rivaroxaban is indicated for:

  1. Reducing risk of stroke and systemic embolism in nonvalvular atrial fibrillation

  2. Treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE)

  3. Thromboprophylaxis post knee or hip replacement

  4. VTE prevention in acutely ill medical patients

  5. Use in paediatric patients with congenital heart disease post Fontan procedure

Market opportunity and sales

• Rivaroxaban (Xarelto) tablets had estimated annual sales of USD 8.05 billion in the US (IQVIA MAT March 2025).

• The approval strengthens Lupin’s position in the high-value cardiovascular and anticoagulant segment.

Manufacturing and global footprint

• Approved tablets will be manufactured in Chhatrapati Sambhajinagar (Aurangabad), Maharashtra.

• Lupin operates in over 100 global markets, with a diversified portfolio across generics, complex generics, biosimilars, and APIs.

Lupin’s FDA approval for rivaroxaban tablets marks another significant milestone in its U.S. generics expansion strategy. With strong market potential and broad clinical use, the launch will further enhance access to affordable anticoagulant therapy for patients across age groups.