Dexcel had filed its new drug application (NDA) with a paragraph IV certification 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 commercialization of its product. The settlement between Dexcel and AstraZeneca resolves this litigation with AstraZeneca waiving forever its claims regarding the three Orange Book patents relating to Dexcel’s product.
The amicable settlement and dismissal with prejudice of the litigation will allow for commercialization of the product once Dexcel receives final regulatory approval from the FDA. Based upon Dexcel’s estimated FDA approval date, Dexcel’s partner Perrigo should be in a position to launch the product by the end of first quarter calendar year 2008.
Under terms of an agreement between Dexcel and healthcare supplier Perrigo, Perrigo will be the exclusive marketer and distributor for the store brand over-the-counter market in the US of the Dexcel-developed and manufactured product.