Intra-Cellular Therapies Resolves Patent Litigation with Sandoz Regarding CAPLYTA®

On January 8, 2025, Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) announced that it has reached a settlement agreement with Sandoz Inc. regarding patent litigation concerning its product CAPLYTA® (lumateperone). CAPLYTA® is approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults and for depressive episodes associated with bipolar I or II disorder (bipolar depression). The agreement arises from litigation initiated by Intra-Cellular Therapies in response to Sandoz’s pursuit of approval to market generic versions of CAPLYTA prior to the expiration of the company’s Orange Book listed patents.

As part of the settlement, Intra-Cellular Therapies has granted Sandoz the right to sell generic versions of CAPLYTA in the U.S. starting from July 1, 2040, or earlier under specific conditions. The company is obligated by law to submit the agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. It is noteworthy that additional patent litigation initiated by Intra-Cellular Therapies against other entities is still pending in the U.S. District Court for the District of New Jersey.

This development is detailed in the company’s press release, included as Exhibit 99.1 in the Current Report on Form 8-K filed with the Securities and Exchange Commission. Notably, this settlement represents a strategic move in addressing legal disputes related to the patent protection of Intra-Cellular Therapies’ vital product CAPLYTA®.

Intra-Cellular Therapies, founded on groundbreaking research that delves into the impact of therapies on cellular processes, specializes in developing treatments for complex psychiatric and neurologic conditions. The company’s commitment to innovation in central nervous system disorders underscores its mission to enhance therapeutic options for those affected by such diseases.

For further information, please visit the company’s official website at www.intracellulartherapies.com.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Intra-Cellular Therapies’s 8K filing here.

About Intra-Cellular Therapies

Intra-Cellular Therapies, Inc, a biopharmaceutical company, focuses on the discovery, clinical development, and commercialization of small molecule drugs that address medical needs primarily in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms in the central nervous system (CNS) in the United States.