Intra-Cellular Therapies Announces Settlement with Sandoz
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a prominent biopharmaceutical company dedicated to developing treatments for central nervous system (CNS) disorders, has reached a significant settlement agreement with Sandoz Inc. This agreement effectively resolves ongoing patent litigation concerning CAPLYTA® (lumateperone). The legal dispute had been filed in the U.S. District Court for the District of New Jersey, originating from Sandoz's submission of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) for the approval of a generic version of CAPLYTA.
Details of the Settlement
The recently finalized settlement permits Sandoz to commence marketing generic alternatives to CAPLYTA as early as July 1, 2040, or potentially sooner, depending on specific criteria being met. In compliance with legal standards, Intra-Cellular Therapies will formally submit this agreement to both the U.S. Federal Trade Commission and the U.S. Department of Justice for review. This development is a crucial milestone for the company as it maintains its focus on innovative treatment options for patients with CNS disorders.
Ongoing Legal Matters
It is noteworthy that while this patent litigation with Sandoz has been amicably resolved, Intra-Cellular Therapies continues to pursue similar patent claims against other entities in the same U.S. District Court. This proactive approach underscores the company's commitment to protecting its intellectual property and the innovations resulting from rigorous research.
About Intra-Cellular Therapies
Founded on groundbreaking research recognized by a Nobel prize, Intra-Cellular Therapies represents a pioneering force in biopharmaceuticals. The company focuses on delineating how various therapies influence cellular mechanisms within the body. By harnessing this intracellular insight, Intra-Cellular Therapies aims to provide innovative, efficacious treatments for individuals living with complex psychiatric and neurological conditions, emphasizing their dedication to scientific breakthroughs that enhance patient care.
Contact Information
For further inquiries about Intra-Cellular Therapies, you can reach out to Juan Sanchez, M.D., Vice President of Corporate Communications and Investor Relations at 646-440-9333. Additionally, Cameron Radinovic of Burns McClellan, Inc. is available at 646-930-4406 for any specific media-related questions.
Frequently Asked Questions
What is the recent settlement concerning?
The settlement resolves patent litigation regarding the drug CAPLYTA® between Intra-Cellular Therapies and Sandoz.
When can Sandoz begin selling generic CAPLYTA®?
Sandoz is permitted to start selling the generic version of CAPLYTA on July 1, 2040, subject to certain conditions.
Why is this settlement significant?
This settlement is crucial for Intra-Cellular Therapies as it allows the company to protect its innovations while facilitating market access to generics for patients.
What does Intra-Cellular Therapies focus on?
Intra-Cellular Therapies specializes in developing treatments for central nervous system disorders through an innovative, research-backed approach.
Who can I contact for more information?
For inquiries, you can contact Juan Sanchez at Intra-Cellular Therapies or Cameron Radinovic at Burns McClellan, Inc.
