Lupin Gets U.S. FDA Approval for Ipratropium Bromide Nasal Spray

Lupin Ltd has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market Ipratropium Bromide Nasal Solution, 0.03% (21 mcg/spray). This drug is a generic equivalent of Atrovent Nasal Spray, 0.03%, originally developed by Boehringer Ingelheim Pharmaceuticals. The medication is prescribed for the symptomatic relief of rhinorrhea associated with allergic and non-allergic perennial rhinitis in individuals aged six years and older.

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Key Takeaways

• FDA Approval: Lupin gains U.S. FDA clearance for Ipratropium Bromide Nasal Solution, 0.03%.

• Market Potential: The generic equivalent of Atrovent Nasal Spray had estimated annual sales of $22 million in the U.S.

• Production Facility: The drug will be manufactured at Lupin’s Pithampur facility in India.

• Financial Performance: Lupin’s Q2 net profit surged 74.4% YoY to ₹852.6 crore, while revenue grew 12.6% to ₹5,672.7 crore.

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Lupin’s Financial Growth and Market Impact

Lupin posted robust Q2 financial results, with a net profit of ₹852.6 crore, exceeding market expectations. The revenue reached ₹5,672.7 crore, showing a 12.6% YoY increase. EBITDA surged 46% YoY to ₹1,340.4 crore, while EBITDA margins expanded to 23.6% from 18% in the prior year.

The company’s strong operational growth reflects its strategic focus on expanding its generics portfolio. However, Lupin share price closed at ₹2,169.85 on the BSE, down by ₹29.70 or 1.35%.

Market Overview of Ipratropium Bromide Nasal Solution

Lupin’s latest FDA approval strengthens its presence in the U.S. generics market. The company's financial resilience and new product launches indicate positive growth momentum. Investors are closely watching Lupin share price as it navigates market fluctuations.

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