Settlement Agreement - Intra-Cellular Therapies has entered into a settlement agreement with Sandoz Inc resolving patent litigation related to CAPLYTA® (lumateperone) [1] - The litigation arose from Sandoz's submission of an Abbreviated New Drug Application to the FDA seeking approval to market a generic equivalent of CAPLYTA [1] - The settlement permits Sandoz to begin selling generic versions of CAPLYTA on July 1, 2040, or earlier under certain circumstances [1] - Intra-Cellular Therapies will submit the agreement to the U S Federal Trade Commission and the U S Department of Justice as required by law [1] - 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 [1] Company Overview - Intra-Cellular Therapies is a biopharmaceutical company focused on developing therapeutics for central nervous system (CNS) disorders [1] - The company was founded on Nobel prize-winning research that allows understanding of how therapies affect the inner-workings of cells in the body [2] - Intra-Cellular Therapies leverages its intracellular approach to develop innovative treatments for complex psychiatric and neurologic diseases [2]
Intra-Cellular Therapies Settles CAPLYTA® (lumateperone) Patent Litigation with Sandoz