Feb 13 2015
Actavis plc (NYSE: ACT) today announced that it has launched its 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 (i) United States Patent No. 7,524,834 is invalid, and (ii) 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 U.S. 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 U.S. brand and generic sales of Pulmicort RESPULES® were approximately $1.1 billion.