Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Lupin Pharmaceuticals

Rhea-AI Summary

Catalyst Pharmaceuticals (NASDAQ:CPRX) has announced a settlement agreement with Lupin Pharmaceuticals regarding patent litigation for FIRDAPSE® (amifampridine). Under the agreement, Lupin receives a license to market a generic version of FIRDAPSE starting February 25, 2035, pending FDA approval.

The settlement resolves the patent litigation initiated by Catalyst and SERB S.A. in response to Lupin's Abbreviated New Drug Application (ANDA). All ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey will be terminated. This follows similar settlements with Teva Pharmaceuticals and Inventia Life Science, while litigation against Hetero remains ongoing.

Positive

• Patent protection for FIRDAPSE secured until February 2035
• Resolution of patent litigation reduces legal uncertainty and costs
• Successfully settled with multiple generic challengers (Teva, Inventia, and now Lupin)

Negative

• Potential generic competition from Lupin after February 2035
• Ongoing patent litigation with Hetero still presents uncertainty

Insights

Pharmaceutical Patent Attorney

Catalyst secures FIRDAPSE patent protection until 2035, eliminating generic competition from Lupin for 10+ years.

Catalyst Pharmaceuticals has successfully settled patent litigation with Lupin Pharmaceuticals regarding its flagship product FIRDAPSE (amifampridine), used for treating rare diseases. This settlement is strategically significant as it prevents Lupin from launching a generic version of FIRDAPSE until February 25, 2035 - extending Catalyst's market exclusivity for nearly a decade.

This agreement represents the third successful patent settlement Catalyst has secured, following similar arrangements with Teva Pharmaceuticals and Inventia Life Science. Only one defendant (Hetero) remains in litigation over FIRDAPSE's Orange Book-listed patents.

From a patent protection standpoint, this settlement provides critical certainty for Catalyst's revenue stream. FIRDAPSE treats Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder, and represents Catalyst's primary commercial product. By preventing generic entry until 2035, Catalyst has effectively secured its market position and revenue generation capability for this specialized medication.

The settlement includes standard provisions allowing for earlier generic entry under certain limited circumstances, which is typical for pharmaceutical patent settlements. These likely include scenarios such as at-risk launches by other generics or invalidation of the patents through separate proceedings.

This resolution demonstrates Catalyst's effective patent strategy in defending its intellectual property while avoiding the unpredictability and expense of continued litigation. With three of four ANDA challengers now settled, Catalyst has substantially reduced patent risk for its core product.

As Part of the Settlement, Lupin Receives a License to Market Generic FIRDAPSE Beginning in February 2035

CORAL GABLES, Fla., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that the Company 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 Catalyst 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 Catalyst/SERB and Lupin regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey. Catalyst previously settled similar litigation regarding ANDA applications for FIRDAPSE with Teva Pharmaceuticals and Inventia Life Science Pty Ltd. The pending FIRDAPSE patent litigation against the remaining defendant, Hetero, regarding FIRDAPSE’s Orange Book-listed patents is ongoing.

As required by law, the companies will submit the confidential settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.

About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence, which remains the cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint. Catalyst, headquartered in Coral Gables, Fla., was recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America’s Fastest-Growing Companies.

For more information, please visit Catalyst's website at www.catalystpharma.com.

Forward-Looking Statements
This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether the ongoing litigation matters referenced above between Catalyst/SERB and Hetero with respect to FIRDAPSE^®’s Orange Book listed patents will allow a generic version of FIRDAPSE to be marketed in the U.S. prior to February 25, 2035, and (ii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2024, its Quarterly Report on Form 10-Q for the fiscal quarter ending June 30, 2025, and its other filings with the U.S. Securities and Exchange Commission ("SEC"), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

Source: Catalyst Pharmaceuticals, Inc.

Investor Contact
Mary Coleman, Catalyst Pharmaceuticals, Inc.
(305) 420-3200
IR@catalystpharma.com

Media Contact
David Schull, Russo Partners
(858) 717-2310
david.schull@russopartnersllc.com

FAQ

When will Lupin be allowed to market generic FIRDAPSE according to the Catalyst Pharmaceuticals settlement?

According to the settlement agreement, Lupin can begin marketing its generic version of FIRDAPSE in the United States on February 25, 2035, pending FDA approval.

What is the current status of CPRX's patent litigation for FIRDAPSE?

Catalyst has successfully settled with Lupin, Teva Pharmaceuticals, and Inventia Life Science. The only remaining patent litigation is against Hetero regarding FIRDAPSE's Orange Book-listed patents.

What is FIRDAPSE and why is it important for Catalyst Pharmaceuticals?

FIRDAPSE (amifampridine) is a novel medicine for patients with rare and difficult-to-treat diseases that represents a significant product in Catalyst's commercial portfolio.

How does the Lupin settlement affect Catalyst Pharmaceuticals' market position?

The settlement provides patent protection until February 2035, securing Catalyst's market exclusivity for FIRDAPSE against Lupin's generic competition until that date.

What regulatory review is required for the CPRX-Lupin settlement agreement?

The settlement agreement must be reviewed by the U.S. Federal Trade Commission and the U.S. Department of Justice, as required by law.