Neurocrine Biosciences Announces Settlement of INGREZZA Abbreviated New Drug Application (ANDA) Litigation

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Nov 13, 2023, 07:00 ET

SAN DIEGO, Nov. 13, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced that is has resolved all patent litigation related to lawsuits resulting from Abbreviated New Drug Applications (ANDAs) brought by companies seeking approval to market a generic version of INGREZZA^® (valbenazine) prior to the expiration of applicable Neurocrine patents. As part of the resolution of these lawsuits, four companies have the right to sell generic versions of INGREZZA in the United States beginning March 1, 2038, or earlier under certain customary circumstances.

"These settlements reinforce our belief in the strength of the INGREZZA intellectual property estate and provide clarity regarding INGREZZA exclusivity. As an innovation-driven biopharmaceutical company, we will continue to develop treatments for under-addressed diseases and rely on a robust patent system to protect that investment in innovation," said Darin Lippoldt, Chief Legal Office of Neurocrine Biosciences.

About Neurocrine Biosciences
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, Parkinson's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (formerly Twitter) and Facebook. (*in collaboration with AbbVie)

NEUROCRINE BIOSCIENCES and NEUROCRINE are registered trademarks of Neurocrine Biosciences, Inc. The Neurocrine logo is a trademark of Neurocrine Biosciences, Inc.

Forward-Looking Statement
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential timing of generic entry. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements include: competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2023. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof.

SOURCE Neurocrine Biosciences, Inc.