Cephalon settles patent litigation with Mylan over Provigil generic

By E. Janene Geiss

Philadelphia, Jan. 10 - Cephalon, Inc. said Tuesday that it has entered into an agreement with Mylan Pharmaceuticals Inc. to settle its pending patent infringement dispute in the United States related to Provigil (modafinil) tablets.

In connection with the settlement, Cephalon said it will grant Mylan a non-exclusive royalty-bearing right to market and sell a generic version of Provigil in the United States, according to a company news release.

Mylan's license will become effective in October 2011 unless Cephalon obtains a pediatric extension for Provigil, which would permit entry by Mylan in April 2012, officials said.

An earlier entry by Mylan may occur based upon the entry of another generic version of Provigil.

The terms of the agreement are confidential and are subject to review by the U.S. Federal Trade Commission. Financial terms were not disclosed.

The parties will promptly file a dismissal with prejudice with the U.S. District Court for the District of New Jersey that will conclude all pending litigation between the parties regarding Provigil, officials said.

This settlement and the previously announced settlements with Teva Pharmaceutical Industries Ltd. and its affiliate and Ranbaxy Laboratories Ltd. do not affect the status of the ongoing Provigil patent litigations between Cephalon and certain other generic companies that are pending in the U.S. District Court in New Jersey, officials said.

These lawsuits claim infringement of Cephalon's U.S. Patent No. RE37,516, which covers pharmaceutical compositions and methods of treatment with the form of modafinil contained in Provigil.

The 516 patent expires Oct. 6, 2014 and may be extended to April 6, 2015 upon submission of pediatric study data that is acceptable to the Food and Drug Administration, officials said.

Mylan is a Canonsburg, Pa., generic pharmaceutical company.

Cephalon is a Frazer, Pa., biopharmaceutical company dedicated to development and marketing of products to treat sleep and neurological disorders, cancer and pain.

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