Intra-Cellular Therapies settles patent litigation with Sandoz, allowing generic CAPLYTA sales starting July 1, 2040.
Quiver AI Summary
Intra-Cellular Therapies, Inc. announced a settlement with Sandoz Inc. regarding patent litigation involving their product CAPLYTA® (lumateperone). This litigation arose from Sandoz's attempt to market a generic version of CAPLYTA through an Abbreviated New Drug Application to the FDA. The agreement allows Sandoz to sell generic CAPLYTA starting July 1, 2040, or earlier under certain conditions. As mandated, Intra-Cellular will submit the settlement to the U.S. Federal Trade Commission and the Department of Justice. Additional patent litigation by Intra-Cellular against other parties is still ongoing in the same court. The company focuses on developing treatments for CNS disorders based on advanced cellular research.
Potential Positives
- The settlement agreement with Sandoz allows Intra-Cellular Therapies to maintain exclusive marketing rights for CAPLYTA® (lumateperone) until July 1, 2040, securing future revenue from the product.
- The resolution of the patent litigation may reduce legal expenses and uncertainties, enabling the company to allocate resources more effectively towards other strategic initiatives.
- By controlling the entry of generic competitors into the market, Intra-Cellular Therapies can enhance its market position and strengthen its product portfolio.
Potential Negatives
- The settlement allows Sandoz to market a generic version of CAPLYTA as early as July 1, 2040, potentially increasing competition and decreasing revenue for Intra-Cellular Therapies once generics are available.
- The ongoing patent litigation with other parties highlights continued vulnerabilities in Intra-Cellular's intellectual property protections, which could lead to further challenges in maintaining market exclusivity.
FAQ
What is the settlement agreement between Intra-Cellular Therapies and Sandoz?
Intra-Cellular Therapies has settled patent litigation with Sandoz regarding the generic version of CAPLYTA, allowing Sandoz to sell it by July 1, 2040.
When will Sandoz be able to sell generic CAPLYTA?
Sandoz can start selling generic versions of CAPLYTA on July 1, 2040, or earlier under specific conditions outlined in the settlement.
Where was the patent litigation filed?
The patent litigation was pending in the U.S. District Court for the District of New Jersey.
What is CAPLYTA used for?
CAPLYTA is a therapeutic product developed by Intra-Cellular Therapies for the treatment of certain central nervous system disorders.
What is Intra-Cellular Therapies' focus?
Intra-Cellular Therapies focuses on developing and commercializing therapeutics for CNS disorders based on innovative intracellular research.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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
This article was originally published on Quiver News, read the full story.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
