Actavis confirmed that the United States Court of Appeals for the Federal Circuit has issued a temporary injunction to prevent Actavis from further distribution of its generic version of Pulmicort Respules (budesonide inhalation suspension) 0.25, 0.5 mg pending its consideration of AstraZeneca's request for an injunction pending appeal.
Actavis' sales of generic Pulmicort have been enjoined pending a hearing on the temporary injunction. A response for the hearing is due to the Court from Actavis by February 20, 2015. The temporary injunction does not address product shipped prior to its issuance.
The Appeals Court ruling followed the February 13, 2015 launch of Actavis' product after the United States District Court for the District of New Jersey found that United States Patent No. 7,524,834 is invalid, and AstraZeneca's request for a permanent injunction is denied.
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.