Rigel Announces Settlement Agreement Resolving TAVALISSE® (fostamatinib disodium hexahydrate) Patent Litigation
Rigel Pharmaceuticals (Nasdaq: RIGL) has reached a settlement agreement with Annora Pharma and Hetero Labs regarding patent litigation for its drug TAVALISSE® (fostamatinib disodium hexahydrate). The litigation arose from Annora's submission of an Abbreviated New Drug Application to the FDA for a generic version of TAVALISSE.
Under the settlement terms, Annora will receive a license to sell its generic product in Q2 2032 or earlier under certain circumstances. All ongoing litigation between the parties regarding TAVALISSE patents pending in New Jersey has been terminated. TAVALISSE is indicated for treating thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatment.
Rigel Pharmaceuticals (Nasdaq: RIGL) ha raggiunto un accordo di transazione con Annora Pharma e Hetero Labs riguardo a contenziosi sui brevetti per il suo farmaco TAVALISSE® (fostamatinib disodico esaidrato). Il contenzioso è sorto a causa della presentazione da parte di Annora di una Richiesta Abbreviata di Nuovo Farmaco all'FDA per una versione generica di TAVALISSE.
Secondo i termini dell'accordo, Annora riceverà una licenza per vendere il suo prodotto generico nel Q2 2032 o prima, in determinate circostanze. Tutti i contenziosi in corso tra le parti riguardanti i brevetti di TAVALISSE pendenti nel New Jersey sono stati terminati. TAVALISSE è indicato per il trattamento della trombocitopenia in pazienti adulti con trombocitopenia immune cronica (ITP) che hanno avuto una risposta insufficiente al trattamento precedente.
Rigel Pharmaceuticals (Nasdaq: RIGL) ha llegado a un acuerdo de conciliación con Annora Pharma y Hetero Labs respecto a litigios por patentes de su medicamento TAVALISSE® (fostamatinib disódico hexahidratado). El litigio surgió a raíz de la presentación por parte de Annora de una Solicitud Abreviada de Nuevo Medicamento a la FDA para una versión genérica de TAVALISSE.
Bajo los términos del acuerdo, Annora recibirá una licencia para vender su producto genérico en el Q2 2032 o antes, bajo ciertas circunstancias. Todos los litigios en curso entre las partes respecto a las patentes de TAVALISSE pendientes en Nueva Jersey han sido terminados. TAVALISSE está indicado para el tratamiento de la trombocitopenia en pacientes adultos con trombocitopenia inmune crónica (ITP) que han tenido una respuesta insuficiente al tratamiento previo.
리겔 제약 (Nasdaq: RIGL)은 자사의 약물 TAVALISSE® (포스타마티닙 이산화물 헥사수화물)에 대한 특허 소송과 관련하여 Annora Pharma 및 Hetero Labs와 합의에 도달했습니다. 이 소송은 Annora가 TAVALISSE의 제네릭 버전으로 FDA에 약물 허가 신청서를 제출함에 따라 발생했습니다.
합의 조건에 따라 Annora는 특정 조건 하에 2032년 2분기 또는 그 이전에 자사의 제네릭 제품을 판매할 수 있는 라이센스를 받게 됩니다. 뉴저지에서 TAVALISSE 특허와 관련된 당사자 간의 모든 진행 중인 소송은 종료되었습니다. TAVALISSE는 이전 치료에 대한 반응이 불충분한 만성 면역성 혈소판 감소증 (ITP) 성인 환자의 혈소판 감소증 치료에 적합합니다.
Rigel Pharmaceuticals (Nasdaq: RIGL) a conclu un accord de règlement avec Annora Pharma et Hetero Labs concernant des litiges sur des brevets pour son médicament TAVALISSE® (fostamatinib disodique hexahydraté). Le litige a surgi suite à la soumission par Annora d'une Demande Abbrégée de Nouveau Médicament à la FDA pour une version générique de TAVALISSE.
Selon les termes de l'accord, Annora recevra une licence pour vendre son produit générique au Q2 2032 ou plus tôt dans certaines circonstances. Tous les litiges en cours entre les parties concernant les brevets de TAVALISSE en attente dans le New Jersey ont été résolus. TAVALISSE est indiqué pour le traitement de la thrombocytopénie chez les patients adultes atteints de thrombocytopénie immunitaire chronique (ITP) qui ont eu une réponse insuffisante à un traitement antérieur.
Rigel Pharmaceuticals (Nasdaq: RIGL) hat eine Vergleichsvereinbarung mit Annora Pharma und Hetero Labs bezüglich von Patentstreitigkeiten für sein Medikament TAVALISSE® (Fostamatinib-Dinatrium-Hexahydrat) erzielt. Der Streit entstand durch die Einreichung eines Abgekürzten Neuen Arzneimittelantrags bei der FDA durch Annora für eine generische Version von TAVALISSE.
Gemäß den Bedingungen des Vergleichs erhält Annora eine Lizenz, um ihr generisches Produkt im Q2 2032 oder früher unter bestimmten Umständen zu verkaufen. Alle laufenden Rechtsstreitigkeiten zwischen den Parteien bezüglich der TAVALISSE-Patente, die im Bundesstaat New Jersey anhängig sind, wurden eingestellt. TAVALISSE ist zur Behandlung von Thrombozytopenie bei erwachsenen Patienten mit chronischer immunologischer Thrombozytopenie (ITP) angezeigt, die auf vorherige Behandlungen unzureichend reagiert haben.
- Patent protection for TAVALISSE secured until at least Q2 2032
- Settlement eliminates ongoing litigation costs and patent uncertainty
- Generic competition for TAVALISSE will begin by Q2 2032, potentially affecting future revenue
Insights
This patent settlement represents a significant victory for Rigel Pharmaceuticals' intellectual property strategy. By securing a Q2 2032 market entry date for Annora's generic version of TAVALISSE, Rigel has effectively extended its exclusivity period by approximately 7 years from now. This timeframe is particularly valuable as it allows Rigel to maximize the commercial potential of TAVALISSE without immediate generic pricing pressure.
The settlement's language regarding "earlier entry under certain circumstances" likely refers to standard pharmaceutical settlement provisions that could accelerate generic entry upon specific triggering events. These typically include situations like other successful patent challenges, regulatory changes, or specific market conditions. However, these conditions usually have high thresholds for activation.
Most importantly, this resolution immediately eliminates ongoing legal expenses and uncertainty that come with patent litigation. For a company with Rigel's market capitalization (
This agreement applies specifically to Annora and doesn't necessarily prevent other generic challengers, but successful defense against one challenger often discourages others from pursuing similar litigation paths, creating a protective halo effect around TAVALISSE's intellectual property position.
This settlement delivers substantial business value to Rigel by securing continued market exclusivity for TAVALISSE in treating chronic immune thrombocytopenia (ITP) until 2032. For specialty medications treating rare conditions like ITP, maintaining pricing power without generic competition directly preserves profit margins and market share.
The certainty of a defined generic entry date allows Rigel to precisely forecast TAVALISSE revenue streams for strategic planning purposes. This seven-year runway provides critical time to potentially develop line extensions, new indications, or next-generation therapies before facing price erosion from generics.
For context, ITP represents a specialized market with substantial unmet needs, as noted in the release that "not all patients respond to existing therapies." By maintaining exclusivity for TAVALISSE, which targets patients who had insufficient response to previous treatments, Rigel preserves its position in this important therapeutic niche.
From a financial perspective, this settlement eliminates litigation uncertainty that often weighs on biotechnology valuations. For a mid-sized company like Rigel, protecting established commercial products is particularly crucial as they typically represent significant revenue contributors and provide funding for pipeline advancement.
While the agreement includes provisions for potential earlier entry "under certain circumstances," the overall outcome secures Rigel's commercial position for TAVALISSE while allowing management to focus resources on expanding their portfolio of "novel therapies with the potential to improve the lives of patients with hematological disorders and cancer" as mentioned in their statement.
"The resolution of this patent litigation underscores the strength of Rigel's intellectual property protecting TAVALISSE, an innovative treatment for people with immune thrombocytopenia," said Raul Rodriguez, Rigel's president and CEO. "We remain committed to advancing our portfolio of novel therapies with the potential to improve the lives of patients with hematological disorders and cancer, and to continue to develop and enhance our intellectual property portfolio."
About ITP
In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.
About TAVALISSE®
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE.
To report side effects of prescription drugs to the FDA, www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).
TAVALISSE is a registered trademark of Rigel Pharmaceuticals, Inc.
About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in
Forward Looking Statements
This press release contains forward-looking statements relating to, among other things, expected generic product market entry, the strength of our intellectual property portfolio and our ability to develop and enhance it, TAVALISSE as a treatment for immune thrombocytopenia, and expectations to grow and advance our commercial portfolio. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "anticipates", "plan", "potential", "may", "look to", "expects", "will", "initial", "promising", and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of fostamatinib, olutasidenib and pralsetinib; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding fostamatinib, pralsetinib or olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that fostamatinib, pralsetinib or olutasidenib may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.
Contact for Investors & Media:
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Media:
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FAQ
When will generic TAVALISSE be available according to Rigel's settlement agreement?
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What medical condition does TAVALISSE treat?
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