Teva Pharma announced (Pressrelease) that United States District Court for the District of New Jersey has granted AstraZeneca's request for a temporary order restraining further “at risk” sales of Teva's generic version of AstraZeneca's Pulmicort (Budesonide) Respules® 0.25mg/2mL and 0.5mg/2mL pending the Court's decision on AstraZeneca's motion for a preliminary injunction. As part of the same ruling, AstraZeneca and its partner Par Pharmaceuticals are to suspend distribution of AstraZeneca's own authorized generic.
A preliminary injunction hearing in this matter is scheduled to begin in November 25, 2008 and a trial has been scheduled for January 12, 2009.
Teva's launch was pursuant to USFDA approval (Here) of its generic version of AstraZeneca's Pulmicort (Budesonide) Respules® and the denial of AstraZeneca's Citizen Petition on this product.
As reported earlier by IPPharmadoc in Septemeber (Here), US District Court of New Jersey has denied Teva’s Motion for Summary Judgment
Innovator is in litigation with Ivax (Teva) on following Orange book listed patents:
US4787536 (Expired on: Aug 27, 2006, now not listed in Orange Book): Which covers a dosage package for storing and discharging a liquid, semi-liquid or pasty product, comprising a squeezing thermoplastic container portion and a discharge portion
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.
Innovator is also in litigation with Breath pharma on ‘099 and ‘603 patents.
A preliminary injunction hearing in this matter is scheduled to begin in November 25, 2008 and a trial has been scheduled for January 12, 2009.
Teva's launch was pursuant to USFDA approval (Here) of its generic version of AstraZeneca's Pulmicort (Budesonide) Respules® and the denial of AstraZeneca's Citizen Petition on this product.
As reported earlier by IPPharmadoc in Septemeber (Here), US District Court of New Jersey has denied Teva’s Motion for Summary Judgment
Innovator is in litigation with Ivax (Teva) on following Orange book listed patents:
US4787536 (Expired on: Aug 27, 2006, now not listed in Orange Book): Which covers a dosage package for storing and discharging a liquid, semi-liquid or pasty product, comprising a squeezing thermoplastic container portion and a discharge portion
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.
Innovator is also in litigation with Breath pharma on ‘099 and ‘603 patents.
No comments:
Post a Comment