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

Synopsis:

Lupin secured U.S. FDA approval for its Ipratropium Bromide Nasal Solution, 0.03%, a generic version of Atrovent Nasal Spray. The drug, used for rhinorrhea relief, had U.S. sales of $22 million. Lupin share price closed at ₹2,169.85, down 1.35%.


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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Lupin Limited

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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.

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

Parameter

Details

Drug Name

Ipratropium Bromide Nasal Solution

Strength

0.03% (21 mcg/spray)

Equivalent to

Atrovent Nasal Spray, 0.03%

Indication

Rhinorrhea relief

Age Group

6 years and above

Manufacturing Facility

Pithampur, India

Annual U.S. Sales

$22 million

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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Published Date : 11 Feb 2025

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Investments in the securities market are subject to market risk, read all related documents carefully before investing. This content is for educational purposes only. Securities quoted are exemplary and not recommendatory.


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Content Partner - Dalal Street Investment Journal Wealth Advisory Private Limited



This article is for educational purposes only and should not be considered investment advice. Market investments are subject to risks. DSIJ Wealth Advisory Private Limited is a SEBI-registered Research Analyst (Reg. No: INH000006396) and Investment Adviser (Reg. No: INA000001142). Please consult your financial adviser before investing. 

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