Item 8.01. Other Events.
On March 28, 2023, Neurocrine Biosciences, Inc. (the "Company") entered into an
agreement with Teva Pharmaceuticals, Inc., and Teva Pharmaceuticals USA, Inc.
(collectively, "Teva") resolving patent litigation related to INGREZZA®, the
Company's medication for the treatment of tardive dyskinesia. The pending patent
litigation was filed by the Company in the United States District Court for the
District of Delaware in response to Teva notifying the Company that it had
submitted an Abbreviated New Drug Application (ANDA) to the United States Food
and Drug Administration seeking approval to market generic versions of INGREZZA
prior to expiration of the Company's Orange Book listed patents. As a result of
this settlement agreement, the Company has granted Teva the right to sell
generic versions of INGREZZA in the United States beginning February 1, 2040 or
earlier under certain circumstances. As required by law, the Company and Teva
will submit the agreement to the United States Federal Trade Commission and the
United States Department of Justice. Similar patent litigation brought by the
Company against three other companies that filed ANDAs seeking approval to
market generic INGREZZA remains pending with a trial date set for January 2,
2024.
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