Amneal Pharmaceuticals has announced the launch of a generic beclomethasone MDI and a generic albuterol MDI in the US, noting that these are its first metered dose inhalers in the US market. The company had announced tentative FDA approval for the beclomethasone MDI in October 2025 and the approval of its ANDA for the albuterol inhaler in December 2025.
In July 2023, Amneal announced that it had submitted an ANDA for a generic version of Teva’s ProAir HFA albuterol MDI. The company received support from the US Federal Trade Commission (FTC) in fighting a Teva patent infringement lawsuit that followed the ANDA submission.
Amneal Senior VP and Chief Scientific Officer, Affordable Medicines, Srinivas Kone commented, “The launch of these two important inhalation products marks a significant milestone for Amneal and underscores the continued expansion of our respiratory platform. 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.”
Read the Amneal Pharmaceuticals press release
