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Catalyst Pharmaceuticals (NASDAQ: CPRX) FIRDAPSE patent trial pushed to May 2026

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

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.

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NASDAQ false 0001369568 0001369568 2026-03-18 2026-03-18
 
 

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

FAQ

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.

Filing Exhibits & Attachments

3 documents
Catalyst Pharmaceuticals Inc

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