Lupin gains US FDA approval for pediatric use of Rivaroxaban oral suspension

Drug firm Lupin Limited on Tuesday (September 30) announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban for Oral Suspension, 1 mg/mL.

The product is bioequivalent to Xarelto for oral suspension, 1 mg/mL of Janssen Pharmaceuticals, Inc., and will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India.

Rivaroxaban for oral suspension is indicated for the 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 five days of initial parenteral anticoagulant treatment.

It is also indicated for thromboprophylaxis in pediatric patients two years and older with congenital heart disease after the Fontan procedure.

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According to IQVIA MAT July 2025 data, Rivaroxaban for Oral Suspension, 1 mg/mL (RLD Xarelto) had estimated annual sales of $11 million in the US.

First Quarter Results

Lupin reported a 52.1% year-on-year jump in net profit to ₹1,219 crore, surpassing CNBC-TV18’s estimate of ₹1,000.3 crore. Revenue for the quarter stood at ₹6,268 crore, up 11.9% from ₹5,600.3 crore a year ago, and largely in line with the street’s forecast of ₹6,288 crore.

The pharmaceutical major’s operating performance saw significant gains, with EBITDA rising 39.2% year-on-year to ₹1,727 crore, well above the estimated ₹1,597.6 crore. EBITDA margin improved to 27.6%, as against 22.2% in the same quarter last year and higher than the expected 25.4%.

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Shares of Lupin Ltd ended at ₹1,920.95, down by ₹10.20, or 0.53%, on the BSE.