AstraZeneca today announced that the US District Court for the District of New Jersey has denied Teva's Motion for Summary Judgment of no infringement in the PULMICORT RESPULES (budesonide inhalation suspension) patent litigation. The court also announced that a trial date will be scheduled and is likely to be in January 2009. AstraZeneca remains focused on preparing for this trial and is confident in the strength of the intellectual property protecting PULMICORT RESPULES.
In October of 2005, AstraZeneca announced that it had filed a lawsuit in the US District Court for the District of New Jersey against IVAX Pharmaceuticals, Inc. (now known as Teva Pharmaceutical Industries Ltd.) for patent infringement. The lawsuit is the result of an abbreviated New Drug Application (ANDA) filed by Teva with the US Food and Drug Administration (FDA) concerning its intent to market a generic version of AstraZeneca's PULMICORT RESPULES in the US prior to the expiration of AstraZenecaâs patents in 2018, with paediatric exclusivity extending to 2019.
The FDA has not approved a generic form of PULMICORT RESPULES, and has not yet responded to AstraZeneca's Citizen Petition, filed in 2006. The Petition outlined AstraZeneca's willingness to work with the FDA to ensure that any follow-on budesonide inhalation suspension product is as safe and effective as 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 2007 totalled $964 million, about 90 percent of which is accounted for by PULMICORT RESPULES.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the 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. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.