Amneal Pharmaceuticals announced that the FDA has approved the company’s ANDA for a generic version of Teva’s ProAir HFA albuterol MDI for the treatment of asthma. Amneal submitted the ANDA in 2023 and was sued by Teva for infringement of patents related to the ProAir’s dose counters in a case that led courts to order delisting of Teva’s device patents for ProAir HFA.
The Amneal MDI is the 4th generic equivalent to ProAir HFA listed as approved by the FDA. Previous approvals include two that were approved in 2020, from Lupin and from Padigis (Perrigo), and one from Armstrong (Amphastar) approved in 2024.
In addition to the albuterol MDI approval, Amneal recently announced tentative FDA approval for a generic version of Teva’s QVAR beclomethasone MDI. The announcement cites the two approvals as evidence of the company’s “momentum in building a differentiated, high-value respiratory portfolio supported by its state-of-the-art manufacturing platform.”
Amneal Senior VP and Chief Scientific Officer, Affordable Medicines, Srinivas Kone commented, “Securing two significant inhalation approvals this quarter, first beclomethasone dipropionate and now albuterol, highlights the tremendous progress our teams have made in a highly complex respiratory category. These achievements are the result of years of hard work, engineering excellence, and investment in our respiratory platform, and they position Amneal to deliver meaningful growth and patient impact.”
Read the Amneal Pharmaceuticals press release
