Actavis confirmed that the United States Court of Appeals for the Federal Circuit has granted AstraZeneca's request for an injunction pending appeal preventing Actavis from further distribution of its generic version of Pulmicort Respules (budesonide inhalation suspension) 0.25, 0.5 mg.
Under the ruling, Actavis' sales of generic Pulmicort have been enjoined pending the resolution of AstraZeneca's appeal before the Court. The Court has set an expedited briefing schedule for the appeal, with expedited briefing to be concluded within 33 days. The injunction does not address product shipped prior to its issuance.
Actavis' sales of generic Pulmicort had previously been enjoined under a temporary injunction granted by the Appeals Court on February 16, 2015. The Appeals Court ruling followed the Feb. 13, 2015 launch of Actavis' product after the United States District Court for the District of New Jersey found United States Patent No. 7,524,834 invalid, and denied AstraZeneca's request for a permanent injunction.
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.