May 20 2009
On May 20, 2009, the US District Court for the District of New Jersey granted the request of AstraZeneca for an injunction barring Apotex (Apotex, Inc. and Apotex Corp.) from launching a generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) in the US. No trial date for the patent litigation has been set.
On March 30, 2009, the US Food and Drug Administration granted approval for a generic version of AstraZeneca's Pulmicort Respules 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.
Pulmicort Respules is a preventive, maintenance asthma medicine indicated for use in children 12 months to 8 years of age in the United States. Full-year US sales for PULMICORT in 2008 totalled $982 million, about 90 percent of which is accounted for by Pulmicort Respules.