Amneal Pharmaceuticals received U.S. Food and Drug Administration approval for its generic albuterol sulfate inhalation aerosol, a 90 µg per actuation product that mirrors the branded PROAIR HFA. The approval marks the company’s second complex inhalation clearance in the past year, following the beclomethasone dipropionate inhalation aerosol, and positions Amneal in a high‑volume, high‑margin segment of the respiratory market.
The U.S. market for albuterol inhalation aerosol is estimated at roughly $1.5 billion in annual sales for the 12 months ending September 2025. By entering this market, Amneal gains access to a sizable revenue stream and strengthens its specialty‑segment mix, which has been a key focus of the company’s strategic transformation away from traditional generics toward higher‑growth, complex dosage forms.
Amneal’s Q3 2025 results reflected the momentum behind its respiratory expansion. Revenue rose to $784.51 million, up 4.5% from $753.00 million in Q3 2024, while adjusted earnings per share reached $0.17, beating the consensus estimate of $0.13 by $0.04 or 30%. The beat was driven by disciplined cost management and a favorable product mix that included the newly approved inhalation aerosol, which helped offset modest price pressure in other generic segments.
Management highlighted the approval as a milestone that demonstrates the company’s ability to navigate the regulatory and manufacturing challenges of complex inhalation products. Senior Vice President and Chief Scientific Officer Dr. Srinivas Kone said the approvals “highlight the tremendous progress our teams have made in a highly complex respiratory category” and signal Amneal’s readiness to capture a share of the high‑volume albuterol market.
The approval is expected to accelerate Amneal’s sales growth and reinforce its trajectory toward a more diversified biopharmaceutical model, with the company positioning the inhalation portfolio as a cornerstone of its specialty‑segment strategy.
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