Actavis to Re-launch Generic Pulmicort Respules Following Favorable Appeals Court Ruling

Actavis will immediately re-launch its generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) 0.25 and 0.5 mg vials following a decision from the US Court of Appeals for the Federal Circuit to uphold a lower court's ruling that US Patent No. 7,524,834 is invalid. The Appeals court also dissolved the injunction preventing Actavis from further distribution of its generic version of Pulmicort Respules that was granted on 12 March 2015.

"We are pleased to be able to supply the market immediately with this product, and we are pleased that the Court of Appeals was able to work so swiftly to address this important matter," said Brent Saunders, CEO and President of Actavis.

Actavis' Abbreviated New Drug Application (ANDA) for its generic version of Pulmicort Respules received final approval from the FDA 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 31 December 2014 total US brand and generic sales of Pulmicort Respules were approximately $1.2 billion.