Amneal Pharmaceuticals has received tentative approval from the U.S. Food and Drug Administration for its generic version of a widely-used asthma inhaler, marking the company's entry into the complex respiratory therapy market and targeting annual sales of approximately $329 million.
The FDA granted tentative approval for Amneal's Abbreviated New Drug Application for beclomethasone dipropionate HFA inhalation aerosol in two strengths (40 mcg/actuation and 80 mcg/actuation). The product serves as the generic equivalent of QVAR, an inhalation aerosol manufactured by IVAX LLC, a member of the Teva Group.
First Respiratory Product Milestone
This approval represents a significant milestone for Amneal as its first metered-dose inhaler (MDI) inhalation product. The achievement reflects years of development work at the company's specialized respiratory facility and establishes a foundation for future growth in complex respiratory therapies.
"Our first metered-dose inhalation product is a landmark achievement for Amneal," said Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer for Affordable Medicines. "This milestone reflects years of dedicated work at our state-of-the-art respiratory facility and marks the beginning of an important new therapeutic category for Amneal."
Clinical Indication and Safety Profile
The beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in patients five years of age and older. The medication is specifically not indicated for the relief of acute bronchospasm.
According to the prescribing information, the most common adverse reactions associated with the treatment include headache, pharyngitis, upper respiratory tract infection, rhinitis, increased asthma symptoms, and inhalation route sinusitis.
Market Opportunity and Growth Strategy
The generic inhaler targets a substantial market opportunity, with IQVIA data showing U.S. annual sales for beclomethasone dipropionate HFA inhalation aerosol reached approximately $329 million for the 12 months ended August 2025.
Dr. Kone emphasized the strategic importance of this development for the company's portfolio expansion: "With additional inhalation programs advancing, we are well positioned to drive a new growth vector within our Affordable Medicines segment."
The tentative approval establishes Amneal's presence in the respiratory therapy market and positions the company to compete in the complex generics space, where technical barriers to entry often provide more sustainable competitive advantages than traditional generic pharmaceuticals.
