The settlements permit the defendants to begin selling generic versions of Gralise on 1 January 2024, or earlier under certain circumstances. The patent litigation continues against Actavis, the other Gralise ANDA filer.
The settlements involve Incepta Pharmaceuticals and Zydus Pharmaceuticals (USA), as well as their affiliated co-defendants.
The agreements are subject to review by the US Department of Justice and the Federal Trade Commission, and entry of an order dismissing the litigation by the US District Court for the District of New Jersey.