Amneal Launches First U.S. MDIs Targeting $1.5B Albuterol and $321M Beclomethasone Markets
Amneal Pharmaceuticals launched its first two metered-dose inhalation aerosols in the U.S.: a generic albuterol sulfate aerosol (90 mcg) and a beclomethasone dipropionate HFA aerosol (40 mcg and 80 mcg). These launches target markets with annual U.S. sales of approximately $1.5 billion for albuterol and $321 million for beclomethasone, filling a device choice gap.
1. Product Launch Details
Amneal Pharmaceuticals introduced albuterol sulfate inhalation aerosol (90 mcg per actuation) and beclomethasone dipropionate HFA inhalation aerosol (40 mcg and 80 mcg) as generic equivalents to PROAIR® HFA and QVAR® Inhalation Aerosol. Both products use a hand-breath actuator device, restoring an option previously discontinued for QVAR® users.
2. Market Opportunity
The U.S. albuterol aerosol market generated approximately $1.5 billion in annual sales, while beclomethasone dipropionate HFA sales reached about $321 million. By addressing this unmet device format, Amneal aims to capture a meaningful share of these high-demand respiratory segments.
3. Manufacturing and Pipeline
These complex MDIs are manufactured at Amneal’s dedicated inhalation facility in Ireland, showcasing the company’s ability to develop and scale intricate formulations. Multiple additional inhalation products are in active development, positioning Amneal for continued growth in the respiratory category.