{"id":959429,"date":"2026-05-07T02:47:18","date_gmt":"2026-05-07T06:47:18","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/catalyst-pharmaceuticals-announces-settlement-of-firdapse-amifampridine-patent-litigation-with-hetero-labs-ltd\/"},"modified":"2026-05-07T02:47:18","modified_gmt":"2026-05-07T06:47:18","slug":"catalyst-pharmaceuticals-announces-settlement-of-firdapse-amifampridine-patent-litigation-with-hetero-labs-ltd","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/catalyst-pharmaceuticals-announces-settlement-of-firdapse-amifampridine-patent-litigation-with-hetero-labs-ltd\/","title":{"rendered":"Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE\u00ae (amifampridine) Patent Litigation with Hetero Labs Ltd."},"content":{"rendered":"
\n

\n As Part of the Settlement, Hetero Labs Ltd. Receives a License to Market Generic FIRDAPSE Beginning in January 2035<\/em>\n <\/p>\n

\n Catalyst has No Other FIRDAPSE Patent Litigation Pending<\/em>\n <\/p>\n

CORAL GABLES, Fla., May 07, 2026 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (\u201cCatalyst\u201d or \u201cCompany\u201d) (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. (\u201cSERB\u201d) have entered into a Settlement Agreement (\u201cAgreement\u201d) with Hetero Labs Ltd., Hetero USA, Grace Consulting Services, Inc., and Annora Pharma Private Limited (collectively, Hetero). This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Hetero\u2019s Abbreviated New Drug Application (\u201cANDA\u201d) seeking approval to market a generic version of FIRDAPSE\u00ae (amifampridine) 10 mg tablets prior to expiration of the applicable patents.<\/p>\n

Pursuant to the terms of the Agreement, Hetero will not market its generic version of FIRDAPSE in the United States any earlier than a specified date in January 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 Hetero regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey prior to the scheduled trial commencement on May 18, 2026. Catalyst previously settled similar litigation regarding ANDA applications for FIRDAPSE with Lupin Pharmaceuticals, Teva Pharmaceuticals, and Inventia Healthcare Limited. This settlement resolves all pending patent litigation relating to FIRDAPSE.<\/p>\n

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.<\/p>\n

\n About\u00a0Catalyst Pharmaceuticals, Inc.<\/strong>
\n
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\u2122 list as one of North America\u2019s Fastest-Growing Companies.<\/p>\n

For more information, please visit Catalyst’s website at www.catalystpharma.com<\/a>.<\/p>\n

\n Forward-Looking Statements<\/strong>
\n
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 those factors described in Catalyst’s Annual Report on Form 10-K for the fiscal year 2025 and its other filings with the\u00a0U.S. Securities and Exchange Commission\u00a0(“SEC”), could adversely affect Catalyst. Copies of Catalyst’s filings with the\u00a0SEC\u00a0are available from the\u00a0SEC, 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.<\/p>\n

Source: Catalyst Pharmaceuticals, Inc.<\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

\n
Investor Contact\r\nMelissa Kendis, Catalyst Pharmaceuticals, Inc.\r\n(305) 420-3200\r\nIR@catalystpharma.com\r\n\r\nMedia Contact\r\nJed Repko \/ Mahmoud Siddig\r\nJoele Frank, Wilkinson Brimmer Katcher\r\n(212) 355-4449<\/pre>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"
As Part of the Settlement, Hetero Labs Ltd. Receives a License to Market Generic FIRDAPSE Beginning in January 2035 Catalyst has No Other FIRDAPSE Patent Litigation Pending CORAL GABLES, Fla., May 07, 2026 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (\u201cCatalyst\u201d or \u201cCompany\u201d) (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. (\u201cSERB\u201d) have entered into a Settlement Agreement (\u201cAgreement\u201d) with Hetero Labs Ltd., Hetero USA, Grace Consulting Services, Inc., and Annora Pharma Private Limited (collectively, Hetero). This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Hetero\u2019s Abbreviated New Drug Application (\u201cANDA\u201d) seeking … <\/p>\n
Continue reading “Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE\u00ae (amifampridine) Patent Litigation with Hetero Labs Ltd.”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-959429","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nCatalyst Pharmaceuticals Announces Settlement of FIRDAPSE\u00ae (amifampridine) Patent Litigation with Hetero Labs Ltd. - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/catalyst-pharmaceuticals-announces-settlement-of-firdapse-amifampridine-patent-litigation-with-hetero-labs-ltd\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE\u00ae (amifampridine) Patent Litigation with Hetero Labs Ltd. - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"As Part of the Settlement, Hetero Labs Ltd. 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