Intra-Cellular settles Caplyta patent litigation with Sandoz

Intra-Cellular Therapies (ITCI) announced that it has entered into a settlement agreement with Sandoz (SDZNY) resolving patent litigation related to Intra-Cellular Therapies’ product Caplyta. The litigation, which is pending in the U.S. District Court for the District of New Jersey, resulted from submission by Sandoz of an Abbreviated New Drug Application to the U.S. FDA seeking approval to market a generic equivalent of Caplyta in the United States. The settlement agreement permits Sandoz to begin selling generic versions of Caplyta on July 1, 2040, or earlier under certain circumstances. As required by law, Intra-Cellular Therapies will submit the agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice. Similar patent litigation brought by Intra-Cellular Therapies against other parties remains pending in the U.S. District Court for the District of New Jersey.