Court Grants AstraZeneca Temporary Restraining Order Against Apotex in Pulmicort Respules Patent Litigation

Friday, 17 April 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.

17 April 2009


About Pulmicort Respules
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.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit:


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