Intra-Cellular Therapies Settles CAPLYTA® (lumateperone) Patent Litigation with Sandoz 

Rhea-AI Summary

Intra-Cellular Therapies (ITCI) has reached a settlement agreement with Sandoz Inc. regarding patent litigation over CAPLYTA® (lumateperone), their CNS disorder therapeutic product. The litigation arose from Sandoz's submission of an Abbreviated New Drug Application seeking approval for a generic version of CAPLYTA in the United States.

Under the settlement terms, Sandoz will be permitted to begin selling generic versions of CAPLYTA on July 1, 2040, or earlier under certain circumstances. The agreement will be submitted to the U.S. Federal Trade Commission and Department of Justice for review. Similar patent litigation against other parties remains ongoing in the U.S. District Court for the District of New Jersey.

Positive

• Patent protection for CAPLYTA secured until July 2040, ensuring market exclusivity
• Settlement eliminates uncertainty and legal costs with one generic competitor

Negative

• Potential for generic competition earlier than July 2040 under certain circumstances
• Ongoing patent litigation with other parties continues to pose risks

BEDMINSTER, N.J., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Sandoz Inc. (Sandoz) resolving patent litigation related to Intra-Cellular Therapies’ product CAPLYTA® (lumateperone). 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. Food and Drug Administration 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. 

About Intra-Cellular Therapies

Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

Contact:

Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333

Burns McClellan, Inc.
Cameron Radinovic
cradinovic@burnsmc.com
646-930-4406

FAQ

When can Sandoz begin selling generic versions of CAPLYTA after the ITCI settlement?

According to the settlement agreement, Sandoz can begin selling generic versions of CAPLYTA on July 1, 2040, or earlier under certain circumstances.

What triggered the patent litigation between ITCI and Sandoz?

The litigation was triggered by Sandoz's submission of an Abbreviated New Drug Application to the FDA seeking approval to market a generic equivalent of CAPLYTA in the United States.

Does the ITCI-Sandoz settlement resolve all pending CAPLYTA patent litigation?

No, 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.

What regulatory review is required for the ITCI-Sandoz patent settlement?

The settlement agreement must be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review, as required by law.