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The court also announced that a trial date will be scheduled and is likelyto be in January of 2009. AstraZeneca remains focused on preparing for thistrial and is confident in the strength of the intellectual property protectingPULMICORT RESPULES.
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In October of 2005, AstraZeneca announced that it had filed a lawsuit inthe US District Court for the District of New Jersey against IVAXPharmaceuticals, Inc. (now known as Teva Pharmaceutical Industries Ltd.) forpatent infringement. The lawsuit is the result of an abbreviated New DrugApplication (ANDA) filed by Teva with the US Food and Drug Administration(FDA) concerning its intent to market a generic version of AstraZeneca'sPULMICORT RESPULES in the US prior to the expiration of AstraZeneca's patentsin 2018, with pediatric exclusivity extending to 2019.
The FDA has not approved a generic form of PULMICORT RESPULES, and has notyet responded to AstraZeneca's Citizen Petition, filed in 2006. The Petitionoutlined AstraZeneca's willingness to work with the FDA to ensure that anyfollow-on budesonide inhalation suspension product is as safe and effective asPULMICORT RESPULES.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged inresearch, development, manufacturing and marketing of prescriptionpharmaceuticals and supplier for healthcare services. AstraZeneca is one ofthe world's leading pharmaceutical companies with healthcare sales of US$29.55 billion and is a leader in gastrointestinal, cardiovascular,neuroscience, respiratory, oncology and infection product sales. AstraZenecais listed in the Dow Jones Sustainability Index (Global) as well as theFTSE4Good Index.
SOURCE AstraZeneca
