Thursday, Cephalon Inc. (CEPH) said it has entered into an agreement in principle with Barr Pharmaceuticals to grant Barr a right to market a generic version of fentora as part of a lawsuit settlement, according to a filing with the Securities and Exchange Commission.
Cephalon said on November 6 the company and certain of its subsidiaries entered into a binding agreement-in-principle with Barr Pharmaceuticals LLC and Barr Laboratories, Inc. to settle its pending patent infringement lawsuit related to fentora.
The lawsuit claims infringement of the Cephalon's Patent regarding methods of use of fentora and do not expire until 2019, and methods of use of solid solution formulations of fentanyl and other compounds, and methods of use, and does not expire until 2019.
The deal does not affect the status of the separate fentora patent litigation between Cephalon and Watson Pharmaceuticals, Inc., Watson Laboratories, Inc. and Watson Pharma, Inc. pending in the District Court in Delaware.
In the filing Cephalon said it will grant Barr a non-exclusive, royalty-free right to market and sell a generic version of fentora in the U.S. effective October 2018.
If another generic version of fentora enters the U.S. market prior to October 2018, Barr may enter the U.S. market on the same date, subject to certain conditions.
Upon execution of the definitive written agreement the Parties will file dismissals with the United States District Court for the District of Delaware, which will conclude the pending litigation between Cephalon and Barr regarding fentora.
Cephalon plans to file the Agreement and the Definitive Agreement with both the U.S. Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice for approval.
Israel-based generic drug maker Teva Pharmaceutical Industries Ltd (TEVA) owns Barr.
CEPH declined $1.09 or 1.82% and closed Thursday's regular trading at $58.84.
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