Lupin Receives US FDA Approval for Generic Atrovent Nasal Spray

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for ipratropium bromide nasal solution (nasal spray), 0.06%, to market a generic equivalent of Atrovent nasal spray, 0.06%, of Boehringer Ingelheim Pharmaceuticals, Inc. The product will be manufactured at Lupin’s Pithampur facility in India.
 
Ipratropium bromide nasal solution (nasal spray), 0.06% is indicated for symptomatic relief of rhinorrhoea (runny nose) associated with the common cold or seasonal allergic rhinitis for adults and children aged 5 years and older.
 
Ipratropium bromide nasal solution (nasal spray), 0.06% (Atrovent) had estimated annual sales of USD 42 million in the US (IQVIA MAT November 2024).
 
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets.

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