Amneal Pharmaceuticals announced the U.S. launch of two generic metered‑dose inhalers on April 14 2026. The first, albuterol sulfate inhalation aerosol, delivers 90 mcg per actuation and is a generic equivalent of PROAIR® HFA. The second, beclomethasone dipropionate HFA inhalation aerosol, offers 40 mcg and 80 mcg per actuation and mirrors the original QVAR® Inhalation Aerosol.
Both inhalers use a hand‑breath actuator that patients depress before inhaling—a design that was discontinued for QVAR® and now provides a new option for patients seeking that delivery method. The launches mark Amneal’s first entry into the complex inhalation category and broaden its Affordable Medicines portfolio beyond oral generics into high‑margin respiratory products.
The company highlighted the market opportunity by noting that the U.S. sales of the branded equivalents were approximately $1.5 billion for PROAIR® HFA and $321 million for QVAR® in the 12 months ended February 2026. Amneal’s generic versions are positioned to capture a share of that demand, leveraging its dedicated inhalation facility in Ireland and FDA approvals received in 2025, including a December 1 2025 approval for albuterol sulfate inhalation aerosol.
Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer – Affordable Medicines, said, "The launch of these two important inhalation products marks a significant milestone for Amneal and underscores the continued expansion of our respiratory platform." He added that the company is "building a durable and differentiated presence in this attractive category" with additional inhalation products in development, underscoring Amneal’s commitment to scaling difficult‑to‑make formulations that address meaningful gaps in patient access.
The launch comes amid strong financial performance in 2025, when Amneal reported net revenue of $814 million for Q4 and $3.02 billion for the full year, and guidance for 2026 of $3.05–3.15 billion in revenue and $720–760 million in adjusted EBITDA. Specialty segment growth of 19% in 2025 and a 4% increase in the Affordable Medicines segment overall support the company’s strategy to shift toward higher‑margin products, while the new inhalers reinforce that trajectory.
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