Lupin receives approval from USFDA for Ipratropium Bromide Nasal Solution

Global pharma major Lupin Limited (Lupin) has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03% (21 mcg/spray), to market a generic equivalent of Atrovent Nasal Spray, 0.03%, of 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 allergic and nonallergic perennial rhinitis in adults and children aged 6 years and older.

Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03% (RLD Atrovent) had estimated annual sales of US $22 million in the U.S. (IQVIA MAT December 2024).