Catalyst Pharma trial over FIRDAPSE patents delayed

Catalyst Pharmaceuticals, Inc. reports that a federal court has postponed the start of its pending patent bench trial against Hetero USA, Inc. The District Court for the District of New Jersey rescheduled the trial from March 23, 2026 to May 18, 2026.

Accepted by SEC EDGAR 03/18/2026 - 05:14 PM EDT Learn about SEC filing dates

Rhea-AI Filing Summary

Catalyst Pharmaceuticals, Inc. reports that a federal court has postponed the start of its pending patent bench trial against Hetero USA, Inc. The District Court for the District of New Jersey rescheduled the trial from March 23, 2026 to May 18, 2026.

The case concerns the validity of Catalyst’s Orange Book-listed patents covering FIRDAPSE, which currently expire in 2032, 2034, and 2037. The filing does not change the claims themselves, but indicates the timetable for resolving this patent dispute has been extended by nearly two months.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Catalyst Pharmaceuticals (CPRX) disclose about its patent trial schedule?

Catalyst Pharmaceuticals disclosed that the District Court for the District of New Jersey postponed the start of its bench trial against Hetero USA, Inc. The trial was moved from March 23, 2026 to May 18, 2026, extending the litigation timetable.

Which product’s patents are involved in Catalyst Pharmaceuticals’ (CPRX) bench trial?

The bench trial involves the validity of Catalyst Pharmaceuticals’ Orange Book-listed patents related to FIRDAPSE. These patents protect the product and are central to the dispute with Hetero USA, Inc. in the District Court for the District of New Jersey.

When do Catalyst Pharmaceuticals’ (CPRX) FIRDAPSE patents expire?

Catalyst Pharmaceuticals stated that its Orange Book-listed patents related to FIRDAPSE expire in 2032, 2034, and 2037. These staggered expiration dates define the potential duration of patent protection that is being challenged in the pending bench trial.

Who is Catalyst Pharmaceuticals’ (CPRX) litigation counterparty in the delayed bench trial?

The litigation counterparty is Hetero USA, Inc. Catalyst Pharmaceuticals reported that the District Court for the District of New Jersey is overseeing a bench trial between the company and Hetero focused on the validity of FIRDAPSE-related patents.

Which court is handling Catalyst Pharmaceuticals’ (CPRX) FIRDAPSE patent dispute?

The patent dispute is being handled by the District Court for the District of New Jersey. Catalyst Pharmaceuticals reported that this court issued the order postponing the bench trial related to FIRDAPSE patents from March 23, 2026 to May 18, 2026.

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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): March 18, 2026

CATALYST PHARMACEUTICALS, INC.

(Exact Name Of Registrant As Specified In Its Charter)

Delaware		001-33057		76-0837053
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

355 Alhambra Circle
Suite 801
Coral Gables, Florida		33134
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (305) 420-3200

Not Applicable

Former Name or Former address, if changed since last report

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class		Name of Exchange on Which Registered		Ticker Symbol
Common Stock, par value $0.001 per share		NASDAQ Capital Market		CPRX

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this Chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events

On March 18, 2026, the District Court for the District of New Jersey filed an order delaying the start of the bench trial between the Company and Hetero USA, Inc. from March 23, 2026 until May 18, 2026. The bench trial relates to the validity of the Company’s Orange Book-listed patents related to FIRDAPSE^® that expire in 2032, 2034, and 2037.

2

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: May 18, 2026

3

Filing Exhibits & Attachments

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• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 2.8 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 17.6 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.0 KB