- Launch of albuterol sulfate inhalation aerosol and beclomethasone dipropionate HFA inhalation aerosol
BRIDGEWATER, N.J., April 14, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. launch of albuterol sulfate inhalation aerosol and beclomethasone dipropionate HFA inhalation aerosol, two widely prescribed respiratory products that were approved by the Food and Drug Administration (FDA) in 2025. These are the Company’s first two metered-dose inhalation (MDI) product launches in the U.S., marking Amneal’s entry into the complex inhalation category.
Albuterol sulfate inhalation aerosol (90 mcg per actuation) is a generic equivalent of PROAIR® HFA. Beclomethasone dipropionate HFA inhalation aerosol (40 mcg and 80 mcg per actuation) is a generic equivalent of the original QVAR® Inhalation Aerosol, 40 mcg and 80 mcg. Both products utilize the hand-breath actuator device in which the cannister is depressed by the patient before inhaling. This option was previously discontinued for QVAR®, creating a potential gap in patient choice.
“The launch of these two important inhalation products marks a significant milestone for Amneal and underscores the continued expansion of our respiratory platform,” said Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer – Affordable Medicines. “Manufactured at our dedicated inhalation facility in Ireland, these complex products reflect our ability to develop and scale difficult-to-make formulations that address meaningful gaps in patient access. With multiple additional inhalation products in active development, we are building a durable and differentiated presence in this attractive category.”
Product Information
Albuterol Sulfate Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
The most common adverse reactions reported with the use of albuterol sulfate inhalation aerosol (≥3.0% and greater than placebo) include headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. For full prescribing information, see package insert here.
Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. It is not indicated for the relief of acute bronchospasm.
The most common adverse reactions reported with the use of beclomethasone dipropionate HFA inhalation aerosol include headache, pharyngitis, upper respiratory tract infection, rhinitis, increased asthma symptoms, and sinusitis. For full prescribing information, please refer to the package insert here.
According to IQVIA® U.S. annual sales data, for the 12 months ended February 2026, albuterol sulfate inhalation aerosol had sales of approximately $1.5 billion, and beclomethasone dipropionate HFA inhalation aerosol had sales of approximately $321 million.
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About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, New Jersey, is a diversified, global biopharmaceutical leader focused on expanding access to affordable and innovative medicines. Founded in 2002 by brothers and co-CEOs Chirag and Chintu Patel, Amneal was built on the belief that innovation only matters if it’s accessible. Today, Amneal has a diverse and growing portfolio of approximately 300 complex generic, specialty and biosimilar medicines, delivering over 160 million prescriptions each year, primarily in the United States. Our Affordable Medicines segment spans retail generics, injectables, and biosimilars. Our Specialty segment provides branded treatments in neurology, including Parkinson’s disease and migraine, and endocrinology. Our AvKARE segment distributes pharmaceuticals and medical products to U.S. federal, retail, and institutional customers. For more, please visit www.amneal.com and follow us on LinkedIn.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com
Source: Amneal Pharmaceuticals LLC