Horizon Pharma, Inc. today announced that it has entered into settlement and license agreements with Par Pharmaceutical Companies, Inc. and its subsidiary Par Pharmaceutical, Inc., to resolve pending patent litigation involving DUEXIS® (ibuprofen and famotidine) tablets.
Under the license agreement, Horizon has granted Par the non-exclusive right to market a generic ibuprofen and famotidine product in the U.S. under Par’s Abbreviated New Drug Application (ANDA), beginning January 1, 2023, or earlier under certain circumstances. Currently, Horizon has listed six Orange Book patents covering DUEXIS.
The settlement agreement includes a stipulation by the parties requesting dismissal without prejudice of the lawsuit filed by Horizon in the U.S. District Court for the District of Delaware relating to the ANDA filed by Par with the U.S. Food and Drug Administration for a generic version of DUEXIS (ibuprofen and famotidine) tablets.
Details of the settlement are confidential, and the agreements are subject to submission to the Federal Trade Commission and the U.S. Department of Justice. The settlement and license agreements will become effective upon the entry by the U.S. District Court for the District of Delaware of an order dismissing without prejudice the litigation with respect to Par.
“We believe this settlement validates the innovation and breadth of the DUEXIS patent portfolio,” said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. “DUEXIS offers important potential advantages to patients suffering from osteoarthritis who are at risk of developing upper gastrointestinal ulcers and we look forward to many years of continued growth.”