Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) has announced that the U.S. Food and Drug Administration (FDA) has approved its albuterol sulfate inhalation aerosol (90 mcg per actuation) — the generic equivalent of PROAIR® HFA from Teva Respiratory LLC.
This marks Amneal’s second complex respiratory product approval in Q4 2025, following the recent FDA approval of its beclomethasone dipropionate inhalation aerosol (QVAR® generic). The double milestone underscores Amneal’s momentum in developing high-value respiratory therapies supported by state-of-the-art manufacturing and formulation technologies.
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Strengthening Amneal’s Position in Complex Respiratory Medicines
According to Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer – Affordable Medicines, “Securing two significant inhalation approvals this quarter highlights the tremendous progress our teams have made in a highly complex category.”
This continued expansion into inhaled and respiratory drug delivery systems demonstrates Amneal’s long-term commitment to creating affordable, accessible respiratory medications for patients across the United States.
Source
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Amneal Pharma LinkedIn page.
Therapeutic Use and Market Insights
Indication
Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults and children 12 years of age and older with reversible obstructive airway disease.
Market Value
According to IQVIA® data for the 12 months ending September 2025, total U.S. sales for albuterol sulfate inhalation aerosol products reached approximately $1.5 billion. With this approval, Amneal enters a substantial market segment with significant growth opportunities in generic respiratory pharmaceuticals.
About Amneal Pharmaceuticals
Headquartered in Bridgewater, New Jersey, Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company focused on making healthcare more accessible.
Its operations span three key business segments:
- Affordable Medicines: Generic pharmaceuticals including injectables, inhalation products, and biosimilars.
- Specialty: Branded products targeting CNS and endocrine disorders.
- AvKARE: A distribution arm serving U.S. federal, retail, and institutional healthcare markets.
With a portfolio of over 290 pharmaceuticals, Amneal continues to strengthen its leadership in complex generics and specialty innovation.
More information is available at www.amneal.com.
Why This Approval Matters for the Generic Inhaler Market
- Expands access: Provides patients with a cost-effective generic alternative to PROAIR® HFA.
- Strengthens competition: Supports pricing balance in the $1.5 billion respiratory inhaler market.
- Enhances innovation: Validates Amneal’s capabilities in formulation chemistry, device integration, and FDA-compliant manufacturing.
These approvals reflect Amneal’s growing expertise in high-barrier, technology-driven respiratory and inhalation therapeutics — a segment historically dominated by a few established players.
Key Takeaway
Amneal’s back-to-back approvals of QVAR® and PROAIR® generics in Q4 2025 represent a major advancement in affordable respiratory care. The company’s investment in complex generics and manufacturing innovation positions it as a front-runner in delivering safe, effective, and accessible respiratory therapies to U.S. patients.