Actavis Confirms Appeals Court Grants Injunction Pending Appeal Related to Generic Pulmicort Respules

Actavis has 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 16 February 2015. The Appeals Court ruling followed the 13 February 2015 launch of Actavis' product after the United States District Court for the District of New Jersey (i) found US Patent No. 7,524,834 invalid, and (ii) 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 30 June 2014, total US brand and generic sales of Pulmicort Respules were approximately $1.1 billion.