UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 21, 2023
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Item 1.01 Entry into a Material Definitive Agreement.
On June 21, 2023, Supernus Pharmaceuticals, Inc. ("Supernus" or the "Company") entered into Settlement and License Agreements (the "Agreements) with Apotex Inc. and Apotex Corp. (collectively, "Apotex"), to settle ongoing patent litigation regarding Apotex's filing of an Abbreviated New Drug Application ("ANDA") seeking approval to market a generic version of the Company's Oxtellar XR® (oxcarbazepine) extended-release tablets. The ANDA included a paragraph IV certification seeking approval to engage in the manufacture, use and sale of the Apotex product prior to the expiration of United States Patent Nos. 7,722,898 (“the ’898 patent”), 7,910,131 (“the ’131 patent”), 8,617,600 (“the ’600 patent”), 8,821,930 (“the ’930 patent”), 9,119,791 (“the ’791 patent”), 9,351,975 (“the ’975 patent”), 9,370,525 (“the ’525 patent”), 9,855,278 (“the ’278 patent”), 10,220,042 (“the ’042 patent”), and 11,166,960 (“the ’960 patent”) (collectively, the "Patents-in-Suit"). Under the terms of the Agreements, the Company and Apotex agreed to dismiss all claims, counter-claims, and defenses asserted by Supernus and Apotex in the ongoing patent litigation. Under the Agreements, the Company grants to Apotex a license to the Patents-in-Suit to Market a generic version of Oxtellar XR® in the United States beginning on September 1, 2024, or earlier under certain circumstances. The Company retained the right itself or through an Affiliate or through any Third Party to Market an authorized generic product. Capitalized terms used but not otherwise defined in this Current Report on Form 8-K have the meanings ascribed to them in the Agreements.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit 104 – The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.
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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.
| SUPERNUS PHARMACEUTICALS, INC. | ||||||||
| DATED: June 23, 2023 | By: | /s/ Timothy C. Dec | ||||||
| Timothy C. Dec | ||||||||
| Senior Vice President and Chief Financial Officer | ||||||||
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