On December 20, 2024, the US Court of Appeals for the Federal Circuit released its opinion in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal ...
MDIs can recognized by the abbreviation HFA (which stands for the propellant hydrofluoroalkane). These include Ventolin HFA, Proventil HFA, Proair HFA, Atrovent HFA, Alvesco HFA, and Asmanex HFA.
The leak rates for the Proventil HFA test and control MDIs were similar ... dose per actuation for both MDIs is 108 µg of albuterol sulfate, which corresponds to 90 µg of albuterol base.
Teva alleged that the patents cover aspects of Teva’s ProAir ® HFA (albuterol sulfate) Inhalation Aerosol. Amneal filed an ANDA application, including a Paragraph IV certification, asserting ...
After exposure to extreme environmental temperatures, an increase in propellant-leak rate was observed with Proventil HFA and Ventolin HFA MDIs, but little to no change was found in particle size ...