Amphastar Pharmaceuticals received U.S. Food and Drug Administration approval on February 24, 2026 for its abbreviated new drug application (ANDA) for Ipratropium Bromide HFA Inhalation Aerosol 17 mcg/actuation, the same dosage and formulation as Boehringer Ingelheim’s Atrovent® HFA Inhalation Aerosol.
The approval confirms that Amphastar’s product is bioequivalent and therapeutically equivalent to Atrovent, and grants the company 180‑day generic drug exclusivity as the first ANDA applicant with a Paragraph IV certification. The FDA clearance removes a regulatory hurdle that had delayed the product’s launch by 18 months and positions Amphastar to capture a share of the U.S. COPD inhaler market, where Atrovent generated approximately $112 million in sales during the 12 months ended December 31, 2025.
Amphastar plans to launch the generic early in the second quarter of 2026. The 180‑day exclusivity period gives the company a competitive advantage in a market dominated by branded inhalers and a few other generics, potentially generating new revenue streams and supporting its strategy to expand both proprietary and generic portfolios.
Dr. Jack Zhang, Amphastar’s President and CEO, said, “We are excited to announce FDA approval of Ipratropium Bromide HFA Inhalation Aerosol, reinforcing the strength of our integrated R&D and manufacturing model and demonstrating our ability to deliver complex, high‑value generics.” He added, “We expect this launch to contribute meaningfully to our respiratory portfolio and to further strengthen our long‑term growth strategy, capabilities and commitment to delivering impactful therapies to patients as we increase our efforts on the development of proprietary pipeline candidates.”
The approval opens a significant opportunity: Atrovent’s U.S. sales of $112 million in 2025 suggest a sizable addressable market. With 180‑day exclusivity, Amphastar can capture a portion of that revenue before other generics enter the market, while also benefiting from the company’s experience in developing complex inhalation products.
The U.S. inhalation drug market was approximately $27 billion in 2024, and Amphastar’s generic development portfolio targets opportunities exceeding $1.3 billion within this market. The approval intensifies competition among major players such as GlaxoSmithKline, Merck, AstraZeneca, and Boehringer Ingelheim, offering a lower‑cost alternative to Atrovent.
Amphastar’s broader pipeline includes biosimilar insulin candidates and other generics, and the company previously received FDA approval for its generic Albuterol Sulfate Inhalation Aerosol in May 2024. The new inhaler launch aligns with Amphastar’s strategy to leverage its manufacturing and regulatory expertise to expand its respiratory portfolio and drive long‑term growth.
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