AstraZeneca had announced that the US District Court of New Jersey has denied Teva’s Motion for Summary Judgment for no willful infringement in the Budesonide inhalation suspension (0.25mg/2ml, 0.5mg /2ml, 1mg /2ml) 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.
Earlier in October of 2005, innovator AstraZeneca announced that it had filed a lawsuit in the US District Court of New Jersey against IVAX Pharma (a unit of Teva) for patent infringement of the following patents which are listed in Orange Book for this product
US6598603 (Expiry: Jun 23, 2019): which covers a method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day.
US6899099 (Expiry: Jun 23, 2019): which covers a method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day, wherein the administration is in the evening.
Budesonide inhalation suspension (0.25mg/2ml, 0.5mg /2ml, 1mg /2ml) was approved by USFDA on Aug 8, 2000. Also, innovator has filed citizen ptetion with USFDA to oppose any generic approval on this product.
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.
Earlier in October of 2005, innovator AstraZeneca announced that it had filed a lawsuit in the US District Court of New Jersey against IVAX Pharma (a unit of Teva) for patent infringement of the following patents which are listed in Orange Book for this product
US6598603 (Expiry: Jun 23, 2019): which covers a method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day.
US6899099 (Expiry: Jun 23, 2019): which covers a method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day, wherein the administration is in the evening.
Budesonide inhalation suspension (0.25mg/2ml, 0.5mg /2ml, 1mg /2ml) was approved by USFDA on Aug 8, 2000. Also, innovator has filed citizen ptetion with USFDA to oppose any generic approval on this product.
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