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

Rhea-AI Summary

Catalyst Pharmaceuticals (NASDAQ:CPRX) has reached a settlement agreement with Lupin Pharmaceuticals regarding patent litigation for FIRDAPSE® (amifampridine). Under the agreement, Lupin will not market its generic version of FIRDAPSE until February 25, 2035, pending FDA approval.

The settlement resolves the 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 Healthcare Limited, while litigation against Hetero remains ongoing.

Positive

• Extended market exclusivity for FIRDAPSE secured until February 2035
• Resolution of patent litigation reduces legal uncertainty and costs
• Maintains control over FIRDAPSE market for next decade

Negative

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

Insights

Pharmaceutical Patent Attorney

Catalyst secures FIRDAPSE exclusivity until 2035 through patent settlement with Lupin, protecting a key revenue stream against generic competition.

Catalyst Pharmaceuticals has successfully defended its FIRDAPSE® (amifampridine) patent rights in a settlement with Lupin Pharmaceuticals. This is the third successful patent defense for FIRDAPSE, following earlier settlements with Teva and Inventia Healthcare Limited.

The settlement grants Lupin a license to market a generic version of FIRDAPSE, but critically, not until February 25, 2035 - approximately 10 years from now. This effectively extends Catalyst's market exclusivity for this rare disease treatment for a significant period, protecting this revenue stream from generic competition.

FIRDAPSE is Catalyst's treatment for Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder. By securing this settlement, Catalyst has eliminated the uncertainty and costs associated with continued litigation while maintaining extended market protection for its flagship product.

The settlement includes standard provisions allowing earlier generic entry under certain limited circumstances, which is typical in pharmaceutical patent settlements. However, the baseline protection until 2035 represents a substantial commercial victory for Catalyst.

The company still faces one remaining patent challenge from Hetero, which remains ongoing. The settlement requires regulatory review by the FTC and DOJ, as is standard practice to ensure compliance with antitrust laws.

For rare disease drug manufacturers, these patent settlements are crucial as they protect the substantial investment made in developing and commercializing treatments for small patient populations. The extended exclusivity period allows Catalyst to continue recouping its investment while maintaining its commercial operations without immediate generic pressure.

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

CORAL GABLES, Fla., Aug. 26, 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 Healthcare Limited. 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's generic version of FIRDAPSE be available under the Catalyst Pharmaceuticals settlement?

Under the settlement agreement, Lupin cannot market its generic version of FIRDAPSE before February 25, 2035, subject to FDA approval and certain limited circumstances.

What is the current status of Catalyst Pharmaceuticals' FIRDAPSE patent litigation?

Catalyst has settled with Lupin, Teva Pharmaceuticals, and Inventia Healthcare, but litigation against Hetero regarding FIRDAPSE's Orange Book-listed patents is still ongoing.

What are the terms of the CPRX settlement with Lupin Pharmaceuticals?

The settlement allows Lupin to market a generic version of FIRDAPSE starting February 2035, pending FDA approval, and terminates all ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey.

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

The settlement secures FIRDAPSE's market exclusivity until February 2035, protecting Catalyst's commercial position for this rare disease treatment for over a decade.