Court grants AstraZeneca prelim injunction against Apotex over Pulmicort

20 May 2009

On May 20, the US District Court for the District of New Jersey granted Anglo-Swedish drug major AstraZeneca's request for an injunction barring  Canadian firm Apotex from launching a generic version of AstraZeneca's  Pulmicort Respules (budesonide inhalation suspension) in the USA. No  trial date for the patent litigation has been set.

On 30 March, the US Food and Drug Administration granted approval for a  generic version of Pulmicort Respules to Apotex. AstraZeneca then filed  suit following Apotex' indication of intent to market a generic version  of the drug in the USA prior to the expiration of AstraZeneca's patents.   The UK-based firm says it has full confidence in the strength of its  intellectual property rights protecting the asthma medication and will  continue to vigorously defend and enforce its IP. Patents covering  Pulmicort Respules expire in 2018 with pediatric exclusivity extending  to 2019, the firm notes.

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