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news.AstraZeneca has filed a lawsuit in the US District Court for the District of New Jersey against Apotex, a Canadian generic drug company, seeking a declaration of patent infringement.
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On March 30, 2009, the FDA granted approval for a generic version of AstraZeneca’s Pulmicort Respules (budesonide inhalation suspension) to Apotex. The lawsuit follows 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.
Additionally, AstraZeneca has filed a motion for interim relief seeking to prohibit sales of Apotex’s generic product until the patent infringement case has concluded. The court has indicated that it will hear oral arguments regarding the motion on April 16, 2009.
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 eight years of age in the US.