Lupin receives U.S. FDA approval for generic Ipratropium Bromide nasal spray
Approval allows marketing of generic equivalent of Atrovent Nasal Spray in the U.S.
Lupin Limited has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03 per cent (21 mcg/spray). This approval allows Lupin to market a generic equivalent of Atrovent Nasal Spray, 0.03 per cent, 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 per cent is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children aged six years and older.
According to IQVIA MAT data from December 2024, Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03 per cent (RLD Atrovent) had estimated annual sales of USD 22 million in the U.S.