Depomed enters into settlement agreement with two Gralise's ANDA filers

Depomed announced it has entered into settlement agreements with two of the three defendants involved in Depomed's ongoing patent infringement litigation against filers of Abbreviated New Drug Applications, or ANDAs, seeking approval to market generic versions of Depomed's Gralise 300 mg and 600 mg tablets. The settlements permit the defendants to begin selling generic versions of Gralise on January 1, 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, as well as their affiliated co-defendants. The agreements are subject to review by the U.S. Department of Justice and the Federal Trade Commission, and entry of an order dismissing the litigation by the U.S. District Court for the District of New Jersey.