Drugmaker Lupin on Tuesday said it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban for Oral Suspension, 1 mg/mL.
The product, bioequivalent to Janssen Pharmaceuticals’ Xarelto, will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India.
It is indicated for the treatment and risk reduction of venous thromboembolism (VTE) in paediatric patients from birth to under 18 years, following at least five days of initial parenteral anticoagulant therapy.
It is also approved for thromboprophylaxis in children aged two years and above with congenital heart disease after the Fontan procedure.
According to IQVIA MAT July 2025 data, the reference product had estimated annual US sales of USD 11 million.
The approval comes as Lupin reported a strong set of quarterly earnings. Net profit surged 52.1 per cent year-on-year to Rs 1,219 crore, beating expectations of Rs 1,000.3 crore.
Revenue rose nearly 12 per cent to Rs 6,268 crore, broadly in line with forecasts. EBITDA jumped 39.2 per cent to Rs 1,727 crore, with margins expanding to 27.6 per cent from 22.2 per cent a year earlier.
Despite the robust results and USFDA approval, shares of Lupin closed marginally lower at Rs 1,920.95, down 0.53 per cent on the BSE. |
