Amphastar got FDA approval for a generic version of Atrovent HFA, a COPD drug, with a Q2 2026 launch and 180-day exclusivity.

Amphastar Pharmaceuticals received FDA approval for its generic Ipratropium Bromide HFA Inhalation Aerosol 17mcg/actuation, deemed bioequivalent to Boehringer Ingelheim’s Atrovent HFA. The drug, used for COPD maintenance treatment, will launch in Q2 2026 with 180 days of exclusivity. Atrovent HFA generated about $112 million in U.S. sales over the past year. Amphastar plans to expand its respiratory and specialty generic pipeline, including injectable and inhalation therapies for oncology, ophthalmology, and inflammatory conditions.