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22 August 2013Americas

Horizon Pharma settles Duexis case with Par Pharmaceuticals

US-based Horizon Pharma Inc agreed on August 22 to settle its patent dispute over arthritis drug Duexis with generic maker Par Pharmaceutical Companies.

Duexis is a tablet that treats the symptoms of rheumatoid arthritis and osteoarthritis. Its combination of ibuprofen and stomach acid inhibitor famotidine was formulated to cut the risk of the patient developing stomach ulcers through its use.

Horizon has six patents covering Duexis listed in the Orange Book, a list of approved drugs published by the US Food and Drug Administration (FDA).

It launched the case against Par, and its subsidiary Par Pharmaceutical Inc, at the US District Court for the District of Delaware in March 2012, claiming Par is infringing a patent related to the Duexis drug. Par said Horizon’s patent is invalid and unenforceable.

The patent covers stable compositions of famotidine and ibuprofen.

The lawsuit was filed in response to Par’s Abbreviated New Drug Application (ANDA), which requested FDA approval to market generic ibuprofen and famotidine tablets.

Under terms of the settlement, Horizon has granted Par a non-exclusive licence to market a generic version of Duexis from January 1, 2023, or earlier under certain circumstances. The parties’ lawsuit will also be dismissed.

The agreements are subject to submission to the Federal Trade Commission and the US Department of Justice.

“We believe this settlement validates the innovation and breadth of the Duexis patent portfolio,” Horizon’s chief executive Timothy Walbert said.