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

CPRX 01.08.2025

Full Press ReleaseSEC FilingsOur CPRX Tweets

About Gravity Analytica

Recent News

  • 01.21.2025 - Catalyst Pharmaceuticals Announces Sub-Licensee DyDo Pharma Launched FIRDAPSE® in Japan
  • 01.16.2025 - 43rd Annual J.P. Morgan Healthcare Conference Presentation Details
  • 01.08.2025 - Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Teva Pharmaceuticals

Recent Filings

  • 01.21.2025 - EX-99.1 EX-99.1
  • 01.21.2025 - 8-K Current report
  • 01.10.2025 - 4 Statement of changes in beneficial ownership of securities
As Part of the Settlement, Teva Receives a License to Market Generic FIRDAPSE Beginning in February 2035

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 licensorSERB S.A.(“SERB”) have entered into a Settlement Agreement (Agreement) withTeva Pharmaceuticals USA, Inc.andTeva 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®(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 inthe United Statesany earlier thanFebruary 25, 2035, if approved by theU.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 theU.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 theU.S. Federal Trade Commissionand theU.S. Department of Justicefor review.

About Catalyst PharmaceuticalsCatalyst 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-establishedU.S.presence while actively seeking to expand its global commercial footprint through strategic partnerships. Catalyst, headquartered inCoral Gables, FL., was recognized as one of North America’s Fastest-Growing Companies on the 2024 Deloitte Technology Fast 500TM List.

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

Forward-Looking StatementsThis 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®’s Orange Book listed patents will allow a generic version of FIRDAPSE to be marketed in theU.S.prior toFebruary 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 endingSeptember 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.

Investor ContactMary Coleman, Catalyst Pharmaceuticals, Inc.(305) 420-3200mcoleman@catalystpharma.comMedia ContactDavid Schull, Russo Partners(858) 717-2310david.schull@russopartnersllc.com

Primary Logo

Source: Catalyst Pharmaceuticals, Inc.

Please be aware that the following content has been generated by an AI system and may contain errors, inconsistencies, or outdated information. It is provided as-is without any warranties or guarantees of accuracy. We strongly recommend using this content as a starting point for further research and consultation with relevant experts or authorities. We disclaim any liability for damages or losses resulting from the use or reliance on this content.Please note that this is a beta version of the Gravity Analytica LLC’s AI Service which isstill undergoing final testing before its official release. Theplatform, its software and all content found on it are provided on an“as is” and “as available” basis. Gravity Analytica LLC does not give any warranties,whether express or implied, as to the suitability or usability of thisservice, webpage, or its software or any of its content.Should you encounter any bugs, glitches, lack of functionality orother problems on the website, please let us know immediately so wecan rectify these accordingly. Your help in this regard is greatlyappreciated! You can write to us at this addressteam@gravityanalytica.com