Innovator AstraZeneca has filed a patent infringement lawsuit against Canadian generic player Apotex to block a generic version of Astra'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.
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 (as reported by IPPharmadoc Here ) 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) has approved ANDA for this product.
Further, innovator Astra has not disclosed whether it was seeking a preliminary injunction or restraining order against Apotex.
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 gneneric exclusivity), Teva has forfeited its 180 days generic exclusivity.
Furthermore, if Apotex agreed to launch this product in US market, the said launch would be "at risk" launch, wherein, generic company can face triple damages, in case of adverse court ruling against generic company.
In the past, some generic players have succesfully launched their generic product 'at risk' in US market. The launch of Fexofenadine and Pentoprazole was 'at risk' launch by Teva. From patent damages perspective, the pharma sector is a quite safe sector and there are hardly any triple damages award against any generic player, thetherefore, many generic players are opting for this lucarative but risky route. Also, innovator companies tries to settle with generic players to stop early generic erosion.
Budesonide inhalation suspension (0.25mg/2ml, 0.5mg /2ml, 1mg /2ml) was approved by USFDA on Aug 8, 2000.
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