Dexcel Pharma and its partner Perrigo settled patent litigation covering three patents [the US6150380, US4853230 and US4786505] with AstraZeneca over the 20 mg delayed-release formulation of Omeprazole Magnesium [Prilosec OTC (R)]. The settlement and dismissal with prejudice of the litigation will allow the generic to be marketed once Dexcel receives final regulatory approval from the Food & Drug Administration.
Based upon Dexcel's estimated FDA approval date, Perrigo expects to be able to launch the product by the end of March 2008. It already has tentative approval for the same. Dexcel had filed its New drug application bearing # 22-032 [505(b)(2); Not an ANDA] stating that AstraZeneca's patents are invalid, unenforceable, or will not be infringed under the NDA. In May 2006, AstraZeneca filed a patent infringement suit to prevent Dexcel from marketing its product. AstraZeneca then filed an amended complaint in Jan. 2007 against Dexcel for these patents.
Friday, November 02, 2007
Another Settlement: Astra Zeneca and Perrigo/ Dexcel
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