U.S. District Court for the District of New Jersey has granted Preliminary injunction decision in favor of innovator AstraZeneca, till decision on pending patent infringement trial (as confirmed by innovator in the press release Here ).
The said decision will block generic launch of Budesonide Respules (Pulmicort) inhalation suspension (0.25mg/2ml, 0.5mg /2ml) by Apotex. Earlier, the same court issued the temporary restraining order against generic launch.
The trial date for this case is yet to be confirmed, which is scheduled in the same court
Background of this case
Innovator AstraZeneca filed a patent infringement lawsuit in April, 2009 against Canadian Pharma giant Apotex to block a generic version of AstraZeneca 's lucrative Budesonide Respules (Pulmicort) inhalation suspension (0.25mg/2ml, 0.5mg /2ml) anti-asthma formulation.
Innovator has listed the following patents 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.
US7524834 (Expiry: May 11, 2019): Which covers a pharmaceutically acceptable, micronized powder composition at least 98.5% by weight of which is pure budesonide or an ester, acetal or salt thereof, wherein the composition meets the criteria of sterility according to the US Pharmacopoeia 23/NF18, 1995, pages 1686-1690 and 1963-1975.
Innovator sued Apotex for the infringement of Orange Book listed patents in U.S. District Court for the District of New Jersey. Also, innovator requested court for preliminary injunction against generic version by Apotex.
Earlier, innovator sued Ivax (Teva) in 2005 and Breath pharma in 2008 for filing ANDA with Para IV against orange book listed patents.
Also, in November 2008 innovator settled with first para IV filer Ivax (Teva) after later launched its product ‘at risk’ in US market in Novemeber, 2008. Subsequently, Teva agreed to settle with innovator and delayed generic launch till December, 2009, however, Teva would pay royalty based on sale of this product to innovator.
As per USFDA records, two generic players Ivax (approved on November 18, 2008) and Apotex (approved on March 30, 2009) have approved ANDA for this product.
Although, Ivax (Teva) is first Para IV filer for this product, however, due to failure to market drug product with in stipulated time of final approval from USFDA (as per Medicare Modernization act provisions on generic exclusivity), Teva has forfeited its 180 days generic exclusivity.
Apotex was ready to launch this product “at risk” to became the first generic player to capture lucrative generic market on this product.
Budesonide inhalation suspension (0.25mg/2ml, 0.5mg /2ml, 1mg /2ml) was approved by USFDA on Aug 8, 2000.
IP Pharma doc’s detailed analysis on this product Here
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