Lupin Secures FDA Approval For Generic Atrovent® Nasal Spray

Lupin Limited announced today that the United States Food and Drug Administration (U.S. FDA) has approved its Abbreviated New Drug Application (ANDA) for Ipratropium Bromide Nasal Solution (Nasal Spray) 0.06% to produce a generic equivalent of Boehringer Ingelheim Pharmaceuticals Inc.'s Atrovent® Nasal Spray 0.06%. Lupin will make this product using facilities located in Pithampur, India. 

The nasal spray formulation of Ipratropium Bromide Nasal Solution 0.06% offers symptom relief for rhinorrhea in typical cold patients and those with seasonal allergic rhinitis for patients older than 5 years. IQVIA MAT November 2024 data indicates total U.S. sales reached USD 42 million annually for Ipratropium Bromide Nasal Solution (Nasal Spray) 0.06% (RLD Atrovent®).