Core Insights - Amphastar Pharmaceuticals has received FDA approval for Ipratropium Bromide HFA Inhalation Aerosol, confirming its bioequivalence and therapeutic equivalence to Boehringer Ingelheim's Atrovent® HFA Inhalation Aerosol [1] - The product is eligible for 180 days of generic drug exclusivity, starting from its commercial launch date [1] - The launch is expected to significantly contribute to Amphastar's respiratory portfolio and long-term growth strategy [1] Product Information - Ipratropium is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) [1] - U.S. sales for Atrovent® HFA were approximately $112 million for the 12 months ending December 31, 2025 [1] - Amphastar plans to launch its Ipratropium Bromide HFA Inhalation Aerosol, previously known as AMP-007, in early Q2 2026 [1] Pipeline and Market Potential - The company has one ANDA and one biosimilar insulin filed with the FDA, targeting products with a combined market size exceeding $1.7 billion [1] - Additionally, there are two biosimilar products in development targeting a market size over $3.7 billion, and two generic products targeting a market size exceeding $1 billion [1] - Amphastar is also developing multiple proprietary products, including four recently in-licensed products targeting oncology and ophthalmology indications [1]