UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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| Item 8.01 | Other Events |
On January 8, 2025, the Company issued a press release announcing that it and its licensor, SERB S.A. (“SERB”) have entered into a Settlement Agreement with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively “Teva”). This agreement resolves the patent litigation brought by the Company and SERB in response to Teva’s Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of FIRDAPSE® (amifampridine) 10 mg tablets prior to the expiration of the applicable patents.
Pursuant to the terms of the settlement agreement, Teva has agreed not to market its generic version of FIRDAPSE® in the United States any earlier than February 25, 2035, if approved by the U.S.. Food and Drug Administration, unless certain limited circumstances customarily included in these types of settlements occur. In accordance with the Agreement, Catalyst/SERB and Teva will terminate all ongoing patent litigation between them that is currently pending in the U.S. District Court for the District of New Jersey.
The Company further reported in the press release that the pending FIRDAPSE® patent litigation against the remaining defendants, Hetero (for all of FIRDAPSE®’s Orange Book-listed patents) and Lupin (only for Catalyst’s FIRDAPSE® patent expiring in 2037) is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of FIRDAPSE® to be marketed in the U.S. prior to February 25, 2035.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits | |
| 99.1 | Press release issued by the Company on January 8, 2025. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Catalyst Pharmaceuticals, Inc. | ||
| By: | /s/ Michael W. Kalb | |
| Michael W. Kalb | ||
| Executive Vice President and Chief Financial Officer | ||
Dated: January 8, 2025
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