Horizon Pharma, Inc. 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 US 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 US District Court for the District of Delaware relating to the ANDA filed by Par with the US 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 US Department of Justice. The settlement and license agreements will become effective upon the entry by the US 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."
Duexis, a proprietary single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond six months.
Horizon Pharma, Inc. is a specialty pharmaceutical company that has developed and is commercializing Duexis and RAYOS/LODOTRA, both of which target unmet therapeutic needs in arthritis, pain and inflammatory diseases.