Catalyst Pharmaceuticals and SERB Settle Patent Litigation with Teva Regarding FIRDAPSE®

Catalyst Pharmaceuticals announces a settlement with Teva regarding FIRDAPSE® patent litigation, delaying generic entry until 2035.

Quiver AI Summary

Catalyst Pharmaceuticals, Inc. has reached a Settlement Agreement with Teva Pharmaceuticals regarding patent litigation over the generic version of FIRDAPSE® (amifampridine) 10 mg tablets. Under this agreement, Teva is prevented from marketing its generic version in the U.S. before February 25, 2035, pending FDA approval, unless specific terms arise that are common in such settlements. This agreement also brings an end to ongoing patent litigation between Catalyst/SERB and Teva, although separate legal actions against other defendants, Hetero and Lupin, continue. Catalyst, committed to developing treatments for rare diseases, has garnered recognition for its growth and is headquartered in Coral Gables, FL. The settlement will be reviewed by the U.S. Federal Trade Commission and the U.S. Department of Justice.

Potential Positives

• The Settlement Agreement with Teva prevents the early marketing of a generic version of FIRDAPSE® until February 25, 2035, securing market exclusivity for an extended period.
• This agreement allows Catalyst to eliminate ongoing patent litigation with Teva, reducing legal costs and potential uncertainties.
• Catalyst Pharmaceuticals was recognized as one of North America’s Fastest-Growing Companies on the 2024 Deloitte Technology Fast 500™ List, indicating strong business growth and market position.

Potential Negatives

• The press release reveals ongoing patent litigation against Hetero and Lupin, indicating continued legal challenges that could impact Catalyst's market position for FIRDAPSE.
• The agreement allows Teva to potentially market its generic version of FIRDAPSE as early as 2035, which may significantly affect Catalyst's market share and revenue from this product in the long term.
• Forward-looking statements highlight significant risks and uncertainties that may adversely affect Catalyst's future performance, indicating vulnerability in their business outlook.

FAQ

What is the recent Settlement Agreement about?

The Settlement Agreement resolves patent litigation between Catalyst, SERB, and Teva regarding the generic version of FIRDAPSE®.

When can Teva market its generic FIRDAPSE®?

Teva will not market its generic version of FIRDAPSE in the U.S. until at least February 25, 2035, if approved by the FDA.

What will happen to the ongoing litigation with other defendants?

The litigation against Hetero and Lupin regarding FIRDAPSE patents is ongoing and will not be affected by the Settlement Agreement with Teva.

What is FIRDAPSE® used for?

FIRDAPSE® (amifampridine) is a medication aimed at treating patients with rare and difficult-to-treat diseases.

How is Catalyst Pharmaceuticals contributing to patient care?

Catalyst focuses on improving accessibility and providing comprehensive support services for patients with rare diseases.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$CPRX Insider Trading Activity

$CPRX insiders have traded $CPRX stock on the open market 21 times in the past 6 months. Of those trades, 0 have been purchases and 21 have been sales.

Here’s a breakdown of recent trading of $CPRX stock by insiders over the last 6 months:

• STEVE MILLER (Chief Op. & Scientific Officer) has traded it 4 times. They made 0 purchases and 4 sales, selling 200,000 shares.
• MOLLY HARPER sold 17,500 shares.
• GARY INGENITO (Chief Med. & Reg. Officer) has traded it 4 times. They made 0 purchases and 4 sales, selling 150,000 shares.
• BRIAN ELSBERND (Chief Compliance/Legal Officer) has traded it 2 times. They made 0 purchases and 2 sales, selling 13,256 shares.
• PATRICK J MCENANY has traded it 7 times. They made 0 purchases and 7 sales, selling 800,000 shares.
• DAVID S TIERNEY sold 15,000 shares.
• CARMEN JEFFREY DEL (Chief Commercial Officer) has traded it 2 times. They made 0 purchases and 2 sales, selling 36,058 shares.

To track insider transactions, check out Quiver Quantitative's insider trading dashboard.

$CPRX Hedge Fund Activity

We have seen 157 institutional investors add shares of $CPRX stock to their portfolio, and 124 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

• DEERFIELD MANAGEMENT COMPANY, L.P. (SERIES C) removed 2,897,671 shares (-31.7%) from their portfolio in Q3 2024
• JANUS HENDERSON GROUP PLC removed 1,815,450 shares (-83.4%) from their portfolio in Q3 2024
• MORGAN STANLEY added 810,595 shares (+80.0%) to their portfolio in Q3 2024
• POINT72 ASSET MANAGEMENT, L.P. removed 618,296 shares (-100.0%) from their portfolio in Q3 2024
• CITADEL ADVISORS LLC removed 557,683 shares (-95.7%) from their portfolio in Q3 2024
• QUBE RESEARCH & TECHNOLOGIES LTD added 538,506 shares (+418.3%) to their portfolio in Q3 2024
• OPALEYE MANAGEMENT INC. removed 527,500 shares (-82.4%) from their portfolio in Q3 2024

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Full Release

CORAL GABLES, Fla., Jan. 08, 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 Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively Teva). This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of FIRDAPSE

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(amifampridine) 10 mg tablets prior to expiration of the applicable patents.

Pursuant to the terms of the Agreement, Teva 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 (FDA), 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 Teva regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey. The pending FIRDAPSE patent litigation against the remaining defendants, Hetero (for all of FIRDAPSE’s Orange Book-listed patents) and Lupin (only for Catalyst’s FIRDAPSE patent expiring in 2037), is ongoing.

As required by law, the companies will submit the confidential license 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 while actively seeking to expand its global commercial footprint through strategic partnerships. Catalyst, headquartered in Coral Gables, FL., was recognized as one of North America’s Fastest-Growing Companies on the 2024 Deloitte Technology Fast 500™ List.

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 and Lupin with respect to FIRDAPSE

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’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 2023, its Quarterly Report on Form 10-Q for the fiscal quarter ending September 30, 2024, 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.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.