Cephalon, Inc. reported today that Sandoz, Inc. has notified Cephalon that it will no longer challenge Cephalon's U.S. particle-size modafinil patent. Instead, Sandoz said it intends to convert its abbreviated new drug application (ANDA) for approval of a generic equivalent of modafinil, the active ingredient contained in PROVIGIL(R) Tablets [C-IV], from a paragraph IV certification to a paragraph III certification. The effect of this conversion is that Sandoz will certify to the U.S. Food and Drug Administration (FDA) that it does not intend to market a generic form of modafinil until the applicable patent for modafinil listed in the Orange Book has expired in 2014. Therefore, it will no longer be necessary for Cephalon to continue to pursue its patent infringement litigation against Sandoz.

Posted by GEN-ERIC at 12:06:33 am into the following categories: In The News

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