Aurobindo Pharma has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, a generic equivalent of Teva’s QVAR RediHaler. The inhaler is approved for long-term preventive maintenance treatment of asthma in patients aged five years and above.
$301 Million Market Opportunity
As per ETPharma, the US market for the approved product and newer versions of QVAR RediHaler was estimated at $301 million for the 12 months ended July 2026, according to IQVIA estimates.
The company expects to launch the product in the upcoming quarters. It will manufacture the inhaler at its Raleigh facility in North Carolina, owned by its wholly owned step-down subsidiary Aurolife Pharma LLC.
Expanding Respiratory Portfolio
Importantly, this approval marks Aurobindo Pharma’s first metered-dose inhaler (MDI) product. The company is expanding into complex respiratory therapies and recently launched another asthma treatment, Advair, in the US.
With the latest approval, Aurobindo Pharma’s cumulative US FDA ANDA approvals have reached 596, including 571 final and 25 tentative approvals.