Amneal Expands Respiratory Portfolio With Launch Of Generic Albuterol and Beclomethasone Products

Amneal Pharmaceuticals has announced the U.S. launch of two respiratory therapies, albuterol sulfate inhalation aerosol and beclomethasone dipropionate HFA inhalation aerosol, marking its entry into the complex metered-dose inhaler (MDI) segment. Both products were approved by the U.S. Food and Drug Administration in 2025 and represent a significant expansion of Amneal’s generics portfolio.

The albuterol inhaler (90 mcg) is a generic version of PROAIR HFA and is indicated for the treatment and prevention of bronchospasm, including exercise-induced bronchospasm, in patients aged four years and older. Meanwhile, the beclomethasone inhalers (40 mcg and 80 mcg) are generics of QVAR and are used as maintenance therapy for asthma in patients aged 5 and above. Notably, both inhalers incorporate a hand-breath actuator, reintroducing an option previously discontinued for QVAR, potentially improving patient choice and usability.

“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.”

From a safety standpoint, commonly reported side effects for albuterol include headache, tachycardia, dizziness, and respiratory tract symptoms, while beclomethasone is associated with headache, upper respiratory infections, and increased asthma symptoms. These profiles are consistent with the known effects of their respective drug classes.

According to IQVIA data for the 12 months ending February 2026, the U.S. market for albuterol inhalation aerosol generated approximately $1.5 billion in annual sales, while beclomethasone inhalation aerosol accounted for around $321 million. These launches position Amneal to capture a share of a substantial and established respiratory therapeutics market.