By Donald Zuhn --
Valeant Pharmaceuticals International announced today (July 2, 2007) that it has settled its patent infringement suit with Kali Laboratories, Inc. (which was acquired by Par Pharmaceutical in June of 2004). Valeant's patent infringement action involved Diastat®, which Valeant markets as the only FDA-approved at-home acute treatment for break-through epileptic seizures.
Xcel Pharmaceuticals, Inc. (which Valeant acquired in March 2005) filed the patent infringement action in July 2004 in the U.S. District Court for the District of New Jersey in response to Kali's submission, in March 2004, of an Abbreviated New Drug Application (ANDA) seeking approval for a generic version of Diastat®.
Under the terms of the agreement, Kali will not introduce a generic version of Diastat® until September 2010. Other terms of the settlement were not disclosed. The companies now have 60 days within which to finalize the agreement.
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