Lupin stock gains 4% on USFDA approval for Rivaroxaban oral suspension; more details

Shares of Lupin Ltd gained 4 per cent in Wednesday’s trade after the company announced it had secured US Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Rivaroxaban for oral suspension, 1 mg/mL.

On Wednesday, Lupin shares climbed as much as 3.9 per cent to touch a day’s high of Rs 1,984.90 on the BSE, up from Tuesday’s close of Rs 1,910.15. By 10:22 am, the stock was trading 3.84 per cent higher at Rs 1,983.50, giving the company a market capitalisation of Rs 90,543 crore. 

In a stock exchange filing dated September 30, Lupin said the approved drug is bioequivalent to Xarelto for Oral Suspension, 1 mg/mL, marketed by Janssen Pharmaceuticals, Inc. The therapy will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India.

The oral suspension is indicated for the treatment of venous thromboembolism (VTE) and for reducing the risk of recurrent VTE in pediatric patients from birth to under 18 years, following at least five days of initial parenteral anticoagulant therapy. It is also approved for thromboprophylaxis in pediatric patients aged two years and above with congenital heart disease following the Fontan procedure, the filing added.

According to IQVIA data for MAT July 2025, Rivaroxaban for Oral Suspension, 1 mg/mL, posted estimated annual sales of around USD 11 million in the U.S.

Commenting on the development, Lupin said, "This approval underscores our commitment to expanding access to critical therapies for pediatric patients."

Lupin, headquartered in Mumbai, operates in over 100 markets globally with 15 manufacturing facilities and seven R&D centres. It enjoys a strong presence in the U.S. and India across therapy areas such as cardiovascular, respiratory, anti-diabetic, gastrointestinal and women’s health.