Lupin gains US FDA approval for Rivaroxaban oral suspension, used to treat venous thromboembolism in children. The drug, bioequivalent to Xarelto, generated $11 million in US sales. Q1 net profit rose 52.1% to ₹1,219 crore.
Source: Lupin Press Release (NSE Exchange Fillings) | Published on Oct 01, 2025
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As quoted in the press release of Lupin (NSE Exchange Filings), the pharmaceutical company has received approval for its Abbreviated New Drug Application (ANDA) for Rivaroxaban for oral suspension (1 mg/mL) from the United States Food and Drug Administration (US FDA). The drug is bioequivalent to Xarelto for oral suspension developed by Janssen Pharmaceuticals, Inc., and will be manufactured at Lupin's Chhatrapati Sambhajinagar facility located in India.
The approval is an exciting addition to Lupin's growing portfolio of paediatric medicines, which enables you to have treatment options for complex conditions such as venous thromboembolism (VTE) in younger patients. This comes as the company is further establishing itself in regulated markets.
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Lupin secures US FDA approval for Rivaroxaban oral suspension, 1 mg/mL.
The product is bioequivalent to Xarelto and will be manufactured in India.
It treats VTE and reduces recurrence risk in paediatric patients.
Estimated annual US sales of the reference product stand at $11 million.
Strong Q1 performance with net profit up 52.1% year-on-year.
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Rivaroxaban oral suspension is a treatment for childhood venous thromboembolism (VTE) and prevention of recurrence in children from birth to less than 18 years of age, after at least 5 days of initial treatment on parenteral anticoagulation. It can also be used for the prophylaxis of VTE in children older than 2 years of age with congenital heart disease who have undergone a Fontan procedure.
The oral suspension is bioequivalent to Xarelto, which helps support similar therapeutic outcomes and provides you with a reliable treatment option. The reference product sales were approximately $ 11 million in the US annually at IQVIA MAT July 2025, indicating stable market demand.
Lupin's financial results for the recent quarter point to a good start for the year. The company reported net profit grew by 52.1% year-on-year to ₹1,219 crore and above consensus estimates. Revenue was up by 11.9% to ₹6,268 crore, which was almost entirely in line with forecasts.
The operating performance was particularly strong, with EBITDA rising by 39.2% to ₹1,727 crore, and margins expanding to 27.6%. The performance reflects both a steady growth strategy and effective cost management, both of which may give you comfort in their financial stability.
Metric | Q1 FY25 | Q1 FY24 | Change |
Net Profit | ₹1,219 crore | ₹801.6 crore | +52.1% |
Revenue | ₹6,268 crore | ₹5,600.3 crore | +11.9% |
EBITDA | ₹1,727 crore | ₹1,240.9 crore | +39.2% |
EBITDA Margin | 27.6% | 22.2% | +5.4% |
Keep an eye on the Lupin share price as it is another metric to watch. As of September 30, 2025, at 15:30 PM IST, the Lupin share price is ₹1,920.95 per share on the BSE, down by ₹10.20 or 0.53%. While the share price is in decline, the company's strong fundamentals and many regulatory approvals bode well for the company's long-term outlook.
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