Aurobindo Pharma has obtained final approval from the U.S. FDA to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol in 40 mcg and 80 mcg strengths. This generic equivalent of Teva’s QVAR Inhalation Aerosol is used for maintenance treatment of asthma. This approval represents Aurobindo’s first metered-dose inhaler and marks its entry into complex inhalation therapies, enhancing its respiratory product portfolio in the U.S. market. The inhaler will be produced at Aurolife Pharma LLC’s manufacturing facility in Raleigh, North Carolina.
The company anticipates a commercial launch in the coming quarters. Aurobindo stated that this development aligns with its strategy to pursue differentiated growth through complex respiratory products. IQVIA data cited by Aurobindo estimates the U.S. market for the approved product and newer versions of the reference product at $301 million for the 12 months ending July 2026. This presents a significant commercial opportunity as the company expands its presence in the U.S. respiratory segment.
