Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Teva Pharmaceuticals
Catalyst Pharmaceuticals (CPRX) and its licensor SERB S.A. have reached a settlement agreement with Teva Pharmaceuticals regarding patent litigation over FIRDAPSE® (amifampridine). The litigation was initiated after Teva filed an Abbreviated New Drug Application seeking to market a generic version of FIRDAPSE 10 mg tablets before patent expiration.
Under the agreement, Teva will not market its generic version of FIRDAPSE in the United States before February 25, 2035, pending FDA approval. The ongoing patent litigation between Catalyst/SERB and Teva in the U.S. District Court for the District of New Jersey will be terminated. However, patent litigation continues against other defendants, including Hetero and Lupin.
Catalyst Pharmaceuticals (CPRX) e il suo licenziante SERB S.A. hanno raggiunto un accordo di transazione con Teva Pharmaceuticals riguardo alle controversie sui brevetti relative a FIRDAPSE® (amifampridina). La causa legale è stata avviata dopo che Teva ha presentato una domanda per un Farmaco Generico Abbreviato per commercializzare una versione generica delle compresse FIRDAPSE da 10 mg prima della scadenza del brevetto.
Secondo l'accordo, Teva non commercializzerà la sua versione generica di FIRDAPSE negli Stati Uniti prima del 25 febbraio 2035, in attesa dell'approvazione della FDA. La controversia sui brevetti in corso tra Catalyst/SERB e Teva presso il Tribunale Distrettuale degli Stati Uniti per il Distretto del New Jersey sarà terminata. Tuttavia, le controversie sui brevetti continuano contro altri convenuti, tra cui Hetero e Lupin.
Catalyst Pharmaceuticals (CPRX) y su licenciante SERB S.A. han alcanzado un acuerdo de conciliación con Teva Pharmaceuticals en relación con la litigio de patentes sobre FIRDAPSE® (amifampridina). El litigio se inició después de que Teva presentara una Solicitud Abreviada de Nuevo Medicamento para comercializar una versión genérica de las tabletas de FIRDAPSE de 10 mg antes de la expiración de la patente.
De acuerdo con el acuerdo, Teva no comercializará su versión genérica de FIRDAPSE en los Estados Unidos antes del 25 de febrero de 2035, a la espera de la aprobación de la FDA. El litigio sobre patentes en curso entre Catalyst/SERB y Teva en el Tribunal de Distrito de los Estados Unidos para el Distrito de Nueva Jersey se cancelará. Sin embargo, la litigio sobre patentes continúa contra otros demandados, incluyendo a Hetero y Lupin.
Catalyst Pharmaceuticals (CPRX)와 그 라이센서 SERB S.A.는 Teva Pharmaceuticals와 FIRDAPSE® (아미팜프리딘)에 대한 특허 소송에 대해 합의했습니다. 소송은 Teva가 FIRDAPSE 10 mg 정제의 제네릭 버전을 특허 만료 전에 판매하려는 약식 신약 신청서를 제출한 후 시작되었습니다.
합의에 따라 Teva는 2035년 2월 25일 이전에 미국에서 FIRDAPSE의 제네릭 버전을 판매하지 않을 것입니다. 뉴저지 지방법원에서 Catalyst/SERB와 Teva 간의 지속 중인 특허 소송은 종료됩니다. 그러나 Hetero 및 Lupin을 포함한 다른 피고에 대한 특허 소송은 계속됩니다.
Catalyst Pharmaceuticals (CPRX) et son concédant SERB S.A. ont conclu un accord de règlement avec Teva Pharmaceuticals concernant les litiges de brevets sur FIRDAPSE® (amifampridine). Le litige a été engagé après que Teva a déposé une Demande de Médicament Abbreviée pour commercialiser une version générique des comprimés de FIRDAPSE 10 mg avant l'expiration du brevet.
Selon l'accord, Teva ne commercialisera pas sa version générique de FIRDAPSE aux États-Unis avant le 25 février 2035, en attendant l'approbation de la FDA. Le litige en cours sur les brevets entre Catalyst/SERB et Teva devant le tribunal de district des États-Unis pour le district du New Jersey sera terminé. Cependant, les litiges sur les brevets se poursuivent contre d'autres défendeurs, y compris Hetero et Lupin.
Catalyst Pharmaceuticals (CPRX) und sein Lizenzgeber SERB S.A. haben eine Vergleichsvereinbarung mit Teva Pharmaceuticals bezüglich der Patentstreitigkeiten über FIRDAPSE® (Amifampridin) erzielt. Die Klage wurde eingereicht, nachdem Teva einen Antrags auf ein Abgekürztes Neues Arzneimittel zur Vermarktung einer generischen Version von FIRDAPSE 10 mg Tabletten vor Ablauf des Patents eingereicht hatte.
Gemäß der Vereinbarung wird Teva seine generische Version von FIRDAPSE in den Vereinigten Staaten vor dem 25. Februar 2035 nicht vermarkten, bis die Genehmigung der FDA vorliegt. Der laufende Patentstreit zwischen Catalyst/SERB und Teva vor dem US-Bezirksgericht für den Bezirk New Jersey wird beendet. Die Patentstreitigkeiten gegen andere Beklagte, einschließlich Hetero und Lupin, dauern jedoch an.
- Secured patent protection for FIRDAPSE against Teva's generic competition until February 2035
- Settlement eliminates patent litigation uncertainty with a major pharmaceutical competitor
- Potential generic competition from Teva starting February 2035
- Ongoing patent litigation with Hetero and Lupin remains unresolved
Insights
This patent settlement with Teva represents a significant legal victory for Catalyst Pharmaceuticals. The agreement effectively protects FIRDAPSE's market exclusivity until February 2035, preventing Teva from launching a generic version before that date. This type of settlement, known as a "pay-for-delay" or "reverse payment" agreement, is common in pharmaceutical patent litigation.
The settlement's structure appears carefully crafted to comply with antitrust scrutiny, particularly given the explicit mention of FTC and DOJ review. Worth noting is that litigation continues against Hetero and Lupin, but securing this agreement with Teva, a major generic manufacturer, substantially strengthens Catalyst's market position. The inclusion of "customary circumstances" language suggests standard acceleration clauses that could allow earlier generic entry if certain market conditions change.
The settlement provides Catalyst with important revenue visibility through 2035 for FIRDAPSE, its flagship product generating approximately
For investors, this agreement essentially establishes a 12-year protected revenue runway for FIRDAPSE. The settlement's timing is particularly strategic as it removes significant market uncertainty and potential generic competition threats. Patent settlements like this typically boost investor confidence as they provide clear timelines for market exclusivity and help in more accurate long-term revenue projections. In simpler terms, Catalyst has secured its main revenue source for over a decade, making it a more stable investment proposition.
This settlement strengthens Catalyst's position in the rare disease market, particularly in Lambert-Eaton Myasthenic Syndrome (LEMS) treatment where FIRDAPSE is the standard of care. The extended exclusivity period allows Catalyst to maintain its pricing power and market dominance in this niche therapeutic area. The remaining patent challenges from Hetero and Lupin pose less immediate threat given Teva's significant market presence and capabilities in generic drug manufacturing.
From a market perspective, this agreement follows a common pattern in the pharmaceutical industry where innovator companies protect their key assets through strategic patent settlements. The extended exclusivity will likely support Catalyst's ongoing expansion efforts and potential development of additional rare disease treatments. For the average investor, think of this as Catalyst securing a 'protective moat' around its primary business for the next decade.
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 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® (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®’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.
FAQ
When will Teva be allowed to market generic FIRDAPSE according to the settlement with CPRX?
What other companies are still in patent litigation with CPRX over FIRDAPSE?
What was the reason for the patent litigation between CPRX and Teva?
How does the Teva settlement affect CPRX's FIRDAPSE patent protection?
