Lupin announced that it has received approval from the US FDA for its Abbreviated New Drug Application for Ipratropium Bromide Nasal Spray, a generic equivalent of Atrovent Nasal Spray, with estimated annual sales of USD 22 million.
Lupin Limited, a global pharmaceutical leader, announced today that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03% (21 mcg/spray).
This approval allows Lupin to market a generic version of Atrovent Nasal Spray, 0.03%, developed by Boehringer Ingelheim Pharmaceuticals, Inc.
The product will be manufactured at Lupin’s Pithampur facility in India. Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03%, is indicated for the symptomatic relief of rhinorrhea associated with both allergic and nonallergic perennial rhinitis in adults and children aged 6 years and older.
According to IQVIA MAT December 2024, the reference listed drug (RLD), Atrovent, had estimated annual sales of USD 22 million in the US.
Lupin Limited is headquartered in Mumbai, India, and distributes products in over 100 markets worldwide. The company focuses on generic formulations, biotechnology products, active pharmaceutical ingredients, and complex generics.
Lupin has established a strong presence in the US and India, particularly in therapeutic areas like respiratory, cardiovascular, anti-diabetic, and anti-infective, among others. It has 15 manufacturing sites and 7 research centers globally, along with a workforce of over 22,000 professionals.
Lupin’s share price is trading at ₹2,094.70 at 10:35 AM on the NSE, marking a decline of ₹74.70 or 3.44% from its previous close of ₹2,169.40. The stock opened at ₹2,178.60 and reached a high of ₹2,178.60, before dropping to a low of ₹2,094.50.
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Published on: Feb 11, 2025, 10:38 AM IST
Neha Dubey
Neha Dubey is a Content Analyst with 3 years of experience in financial journalism, having written for a leading newswire agency and multiple newspapers. At Angel One, she creates daily content on finance and the economy. Neha holds a degree in Economics and a Master’s in Journalism.
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