SEC Form 8-K filed by Intra-Cellular Therapies Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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ITEM 8.01 Other Events.
On January 8, 2025, Intra-Cellular Therapies, Inc. (the “Company”) entered into an agreement with Sandoz Inc. (“Sandoz”) resolving patent litigation related to the Company’s product CAPLYTA® (lumateperone), which is approved by the U.S. Food and Drug Administration (the “FDA”) for the adult treatment of schizophrenia and for the adult treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. The pending patent litigation was filed by the Company in the U.S. District Court for the District of New Jersey in response to Sandoz notifying the Company that it had submitted an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to market generic versions of CAPLYTA prior to expiration of the Company’s Orange Book listed patents. As a result of this settlement agreement, the Company has granted Sandoz the right to sell generic versions of CAPLYTA in the United States beginning July 1, 2040, or earlier under certain circumstances. As required by law, the Company will submit the agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice. Similar patent litigation brought by the Company against other parties remains pending in the U.S. District Court for the District of New Jersey.
The Company’s press release announcing the settlement agreement with Sandoz is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
ITEM 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number |
Description | |
| 99.1 | Press release dated January 10, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
The press release may contain hypertext links to information on the Company’s website. The information on the Company’s website is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INTRA-CELLULAR THERAPIES, INC. | ||
| By: | /s/ Sanjeev Narula | |
| Sanjeev Narula | ||
| Executive Vice President, Chief Financial Officer and Treasurer | ||
| Date: | January 10, 2025 | |