Lupin generic FIRDAPSE delayed to 2035 in Catalyst (NASDAQ: CPRX) deal

Rhea-AI Filing Summary

Catalyst Pharmaceuticals, Inc. has entered into a settlement agreement with Lupin Ltd. and Lupin Pharmaceuticals, Inc. over patent litigation related to a proposed generic version of FIRDAPSE (amifampridine) 10 mg tablets. Under the agreement, Lupin will not market its generic FIRDAPSE in the United States any earlier than February 25, 2035, if it receives U.S. Food and Drug Administration approval, except in certain limited customary circumstances. All ongoing FIRDAPSE patent litigation between Catalyst, its licensor SERB S.A., and Lupin in the U.S. District Court for the District of New Jersey will be terminated. Catalyst notes that separate FIRDAPSE patent litigation against Hetero covering all Orange Book-listed patents remains ongoing, and there is no assurance that a generic version will be kept off the U.S. market until February 25, 2035.

Positive

• Settlement delays Lupin’s generic FIRDAPSE entry: Lupin agrees not to market its generic FIRDAPSE in the U.S. before February 25, 2035, if approved, removing one major generic challenger for an extended period.

Negative

• Key FIRDAPSE patent case with Hetero remains unresolved: Litigation against Hetero covering all Orange Book-listed FIRDAPSE patents is ongoing, and the company states there is no assurance a generic will be blocked until February 25, 2035.

Insights

Pharmaceutical IP and exclusivity analyst

Settlement delays one FIRDAPSE generic until 2035 but another challenge remains.

Catalyst Pharmaceuticals and its licensor SERB S.A. have resolved patent litigation with Lupin over a proposed generic FIRDAPSE. The settlement states Lupin will not market its generic FIRDAPSE in the U.S. before February 25, 2035, if approved by the FDA, except in limited customary circumstances. This effectively preserves exclusivity from this particular challenger for roughly a decade from the agreement date.

The parties will terminate all ongoing patent litigation between Catalyst/SERB and Lupin in the U.S. District Court for the District of New Jersey, removing legal uncertainty and associated costs from that dispute. However, Catalyst reports that FIRDAPSE patent litigation against Hetero for all Orange Book-listed patents is still ongoing, and explicitly cautions that there can be no assurance a generic will be prevented from entering the U.S. market before February 25, 2035.

From an investor perspective, the settlement with Lupin clarifies that this specific ANDA filer cannot launch a generic before 2035, subject to the agreement’s limited exceptions. The ultimate durability of FIRDAPSE’s market position will also depend on the outcome of the separate Hetero case and any future challenges, which are not resolved here and will be reflected in subsequent disclosures.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

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

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

NASDAQ false 0001369568 0001369568 2025-08-25 2025-08-25

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): August 25, 2025

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 August 25, 2025, the Company issued a press release announcing that it and its licensor, SERB S.A. (“SERB”) have entered into a settlement agreement (“Agreement”) with Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”). This Agreement resolves the patent litigation brought by the Company and SERB in response to Lupin’s Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of FIRDAPSE^® (amifampridine) 10 mg tablets prior to expiration of the applicable patents.

Pursuant to the terms of the Agreement, Lupin will not 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 agreements occur. In accordance with the Agreement, the parties will terminate all ongoing patent litigation between the Company/SERB and Lupin regarding FIRDAPSE^® patents pending in the U.S. District Court for the District of New Jersey. The Company previously settled similar litigation regarding ANDA applications for FIRDAPSE^® with Teva Pharmaceuticals and Inventia Life Science Pty Ltd.

The Company further reported in the press release that the pending FIRDAPSE^® patent litigation against the remaining defendant, Hetero (for all of FIRDAPSE^®’s Orange Book-listed patents) 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 August 25, 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: August 25, 2025

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FAQ

What did Catalyst Pharmaceuticals (CPRX) announce regarding FIRDAPSE patent litigation?

Catalyst Pharmaceuticals reported that it and its licensor SERB S.A. entered into a settlement agreement with Lupin Ltd. and Lupin Pharmaceuticals, Inc. resolving patent litigation over Lupin’s ANDA for a generic version of FIRDAPSE (amifampridine) 10 mg tablets.

When can Lupin launch a generic version of FIRDAPSE in the U.S. under the settlement?

Under the agreement, Lupin will not market its generic version of FIRDAPSE in the United States any earlier than February 25, 2035, if it is approved by the U.S. Food and Drug Administration, except in certain limited customary circumstances.

What happens to the existing FIRDAPSE patent litigation between Catalyst and Lupin?

The agreement provides that all ongoing FIRDAPSE patent litigation between Catalyst Pharmaceuticals and SERB S.A. on one side and Lupin on the other in the U.S. District Court for the District of New Jersey will be terminated.

Does Catalyst Pharmaceuticals (CPRX) still face other FIRDAPSE patent challenges?

Yes. Catalyst states that FIRDAPSE patent litigation against the remaining defendant, Hetero, covering all Orange Book-listed FIRDAPSE patents is ongoing, and there is no assurance this will prevent a generic from entering the U.S. market before February 25, 2035.

Which product is at the center of this settlement for Catalyst Pharmaceuticals?

The settlement relates to FIRDAPSE, an amifampridine 10 mg tablet product, and Lupin’s Abbreviated New Drug Application seeking approval to market a generic version before the expiration of applicable patents.

Have other FIRDAPSE ANDA disputes been resolved previously by Catalyst?

Catalyst notes that it previously settled similar FIRDAPSE-related ANDA patent litigation with Teva Pharmaceuticals and Inventia Life Science Pty Ltd.