Lupin Limited has secured approval from the U.S. Food and Drug Administration (FDA) 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 equivalent of Atrovent® Nasal Spray, 0.03%, originally developed by Boehringer Ingelheim Pharmaceuticals, Inc.
Manufactured at Lupin’s Pithampur facility in India, this nasal spray is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with allergic and nonallergic perennial rhinitis in adults and children aged six years and older.
The reference drug, Atrovent® Nasal Spray, 0.03%, had an estimated annual sales of USD 22 million in the U.S. (IQVIA MAT December 2024). Lupin’s FDA approval strengthens its position in the U.S. pharmaceutical market, offering an affordable and effective alternative to patients suffering from chronic nasal conditions.
Recently, Lupin Limited (Lupin) and its partner Natco Pharma Limited (Natco) have secured U.S. FDA approval for Natco’s Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension, 32 mg. This approval allows them to market a generic version of Tracleer® Tablets for Oral Suspension by Actelion Pharmaceuticals US, Inc. As the exclusive first-to-file applicant, Natco holds a 180-day market exclusivity, offering a strategic advantage in the U.S. pharmaceutical industry.
