Apr 16 2009
On 16 April 2009, the US District Court for the District of New Jersey granted AstraZeneca's request for a temporary restraining order, barring Apotex (Apotex, Inc. and Apotex Corp.) from launching a generic version of AstraZeneca's PULMICORT RESPULES until further order of the court.
On 27 April 2009, the court will commence a hearing to determine whether the injunction should be continued.
On 30 March 2009, the US FDA granted approval for a generic version of AstraZeneca's PULMICORT RESPULES (budesonide inhalation suspension) to Apotex. AstraZeneca then filed suit following Apotex's indication of intent to market a generic version of AstraZeneca's PULMICORT RESPULES in the US prior to the expiration of AstraZeneca's patents.
AstraZeneca has full confidence in the strength of its intellectual property rights protecting PULMICORT RESPULES and will continue to vigorously defend and enforce its intellectual property.
Patents covering PULMICORT RESPULES expire in 2018 with pediatric exclusivity extending to 2019.