Actavis has launched generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) 0.25 and 0.5 mg vials following a ruling from the United States District Court for the District of New Jersey that United States Patent No. 7,524,834 is invalid, and AstraZeneca's request for a permanent injunction is denied.
Actavis' Abbreviated New Drug Application ("ANDA") for its generic version of Pulmicort Respules received final approval from the US Food and Drug Administration in August 2012.
Pulmicort Respules is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. For the 12 months ended June 30, 2014 total US brand and generic sales of Pulmicort Respules were approximately $1.1 billion.