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Atossa Advances Global Patent Strategy for Z-Endoxifen with New Protection in Israel and Ongoing Renewals

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Atossa Therapeutics (NASDAQ: ATOS) announced expansion of its global intellectual-property strategy for Z-endoxifen, including issuance of an Israeli patent (No. 304863) granted on July 2, 2025 and a Certificate of Patent Renewal confirming fee payment and active status.

The Israeli claims cover oral delayed-release enteric dosage forms with at least 90% Z-endoxifen, optional impurity limits (<2%), defined gastric/intestinal release characteristics, dose strengths (e.g., 1–4 mg and 8 mg), pharmacokinetic targets, and manufacturing methods that enrich the Z-isomer via crystallization and solvent control.

Atossa Therapeutics (NASDAQ: ATOS) ha annunciato l'espansione della sua strategia globale di proprietà intellettuale per Z-endoxifen, inclusa l'emissione di un brevetto israeliano (No. 304863) concesso il 2 luglio 2025 e un Certificato di Rinnovo del Brevetto che conferma il pagamento delle tasse e lo stato attivo.

Le rivendicazioni israeliane riguardano forme di dosaggio orali a rilascio ritardato enteriche con almeno 90% Z-endoxifen, limiti di impurità opzionali (<2%), caratteristiche di rilascio gastrico/intestinale definite, dosi (ad es. 1–4 mg e 8 mg), obiettivi farmacocinetici e metodi di produzione che arricchiscono l'isomero Z tramite cristallizzazione e controllo del solvente.

Atossa Therapeutics (NASDAQ: ATOS) anunció la expansión de su estrategia global de propiedad intelectual para Z-endoxifen, incluida la emisión de una patente israelí (No. 304863) concedida el 2 de julio de 2025 y un Certificado de Renovación de Patente que confirma el pago de las tasas y el estado activo.

Las reivindicaciones israelíes cubren formas de dosificación oral entérica de liberación retardada con al menos 90% de Z-endoxifen, límites de impurezas opcionales (<2%), características definidas de liberación gástrica/intestinale, dosis (p. ej., 1–4 mg y 8 mg), objetivos farmacocinéticos y métodos de fabricación que enriquecen el isómero Z mediante cristalización y control del disolvente.

Atossa Therapeutics (NASDAQ: ATOS)Z-endoxifen에 대한 글로벌 지적 재산 전략의 확장을 발표했습니다. 여기에는 2025년 7월 2일에 부여된 이스라엘 특허(번호 304863) 발행과 요금 납부 및 활성 상태를 확인하는 특허 갱신 증명이 포함됩니다.

이스라엘의 청구항은 최소 90% Z-endoxifen을 포함하는 경구 지연 방출 엔터릭 제형, 선택적 불순물 한도 (<2%), 정의된 위장/장 방출 특성, 용량 강도(예: 1–4 mg8 mg), 약동학적 목표 및 Z-이성질체를 결정화 및 용매 제어를 통해 풍부하게 하는 제조 방법을 다루고 있습니다.

Atossa Therapeutics (NASDAQ: ATOS) a annoncé l'expansion de sa stratégie mondiale de propriété intellectuelle pour Z-endoxifen, y compris l'octroi d'un brevet israélien (No. 304863) accordé le 2 juillet 2025 et un Certificat de renouvellement de brevet attestant du paiement des taxes et de l'état actif.

Les revendications israéliennes couvrent des formes posologiques orales à libération différée entérique avec au moins 90% de Z-endoxifen, des limites d'impureté facultatives (<2%), des caractéristiques de libération gastrique/intestinale définies, des seuils de dosage (par ex. 1–4 mg et 8 mg), des objectifs pharmacocinétiques et des méthodes de fabrication qui enrichissent l'isomère Z par cristallisation et contrôle du solvant.

Atossa Therapeutics (NASDAQ: ATOS) gab die Erweiterung ihrer globalen Strategie für geistiges Eigentum rund um Z-endoxifen bekannt, einschließlich der Erteilung eines israelischen Patents (Nr. 304863) am 2. Juli 2025 und eines Zertifikats zur Patent-Renewal, das die Zahlung der Gebühren und den aktiven Status bestätigt.

Die israelischen Ansprüche decken orale, verzögerte Freisetzungs-Enterik-Darreichungen mit mindestens 90% Z-endoxifen, optionale Verunreinigungsgrenzen (<2%), definierte Magen-Darm-Freisetzungsmerkmale, Dosierungsstärken (z. B. 1–4 mg und 8 mg), pharmakokinetische Ziele und Herstellungsverfahren ab, die das Z-Isomer durch Kristallisation und Lösungsmittelkontrolle angereichert.

Atossa Therapeutics (NASDAQ: ATOS) أعلنت عن توسيع استراتيجيتها العالمية للملكية الفكرية لـ Z-endoxifen، بما في ذلك إصدار براءة اختراع إسرائيلية (رقم 304863) مُنحت في 2 يوليو 2025 وشهادة تجديد البراءة تؤكد سداد الرسوم وحالة النشط.

نطاق المطالبات الإسرائيلية يغطي أشكال جرعات فموية بإطلاق مؤجل مع غشاء Enteric مع ما لا يقل عن 90% Z-endoxifen، حدود الشوائب الاختيارية (<2%)، ميزات إطلاق محددة للمعدي/الأمعاء، قوى الجرعات (مثلاً 1–4 mg و 8 mg)، أهداف الدوائية الحركية وطرق التصنيع التي تثري النظير Z من خلال التبلور والتحكم بالمذيب.

Atossa Therapeutics (NASDAQ: ATOS) 宣布扩大其全球知识产权策略,涉及 Z-endoxifen,包括授予的以色列专利(编号304863)2025年7月2日,以及确认已缴费并处于有效状态的专利续期证书。

以色列的权利要求涵盖至少 90% 的 Z-endoxifen 的口服缓释肠溶制剂、可选的不纯物限值(<2%)、定义的胃/肠释放特征、剂量强度(例如 1–4 mg8 mg)、药代动力学目标,以及通过晶析和溶剂控制来富集 Z 异构体的制造方法。

Positive
  • Israeli patent granted (No. 304863) on July 2, 2025
  • Claims include enteric oral forms ≥90% Z-endoxifen
  • Claims specify impurity limits <2%, dose strengths 1–4 mg and 8 mg
  • Received Certificate of Patent Renewal confirming paid fees and active status
Negative
  • None.

Insights

Issuance and renewal of an Israeli patent strengthens Atossa's Z-endoxifen IP coverage relevant to clinical and commercial plans.

The patent (No. 304863) granted in Israel on July 2, 2025 claims high-purity oral, delayed-release formulations (≥90% Z-endoxifen), impurity limits (2%), defined in-vitro release and pharmacokinetic performance targets, dose ranges (e.g., 1–4 mg and 8 mg), and manufacturing methods to enrich the Z-isomer. These elements create technical barriers around product composition, defined performance criteria, and specific manufacturing steps, which support product quality control and life-cycle management in that jurisdiction.

Dependencies and risks include maintaining timely renewals and successful prosecution in other jurisdictions where the company seeks protection; the release notes an Israeli Certificate of Patent Renewal for the same patent. Watch ongoing renewals, the status of parallel filings in other major jurisdictions, and any claim scope changes during prosecution. The relevant near- to mid-term horizon is the period of active prosecution and renewal filings as the program advances through clinical development (2025 onward as stated).

Claims tying formulation, performance, and manufacturing methods create practical exclusivity levers for commercialization and quality control.

By claiming enteric delayed-release dosage forms with explicit purity, release profiles, and pharmacokinetic targets, the patent links product identity to measurable attributes. Coverage of stepwise crystallization and solvent control methods targets the supply-chain and process steps needed to produce the claimed high-purity Z-isomer, which can support enforcement against products that reproduce the same technical route or performance.

Key items to monitor are the exact claim language as allowed during prosecution in each jurisdiction, renewal fee status across the portfolio, and any oppositions or third‑party challenges if they arise. These procedural events will determine practical exclusivity windows and the timing of when patent strength materially affects commercial or partnering discussions over the coming years (2025 and thereafter as filings progress).

Portfolio covers high-purity Z-endoxifen enteric formulations, performance characteristics, and manufacturing methods, part of Atossa's multi-jurisdiction IP strategy to support clinical and commercial plans

SEATTLE, Oct. 13, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, announces key progress in its global intellectual-property strategy for Z-endoxifen, including the issuance of an Israeli patent and continued renewals that reinforce protection for the Company's lead program across major jurisdictions. The Israeli patent (No. 304863), titled, "Methods for Making and Using Endoxifen," was granted on July 2, 2025, with priority to multiple U.S. provisional applications filed in 2017–2018.

The allowed claims in Israel include oral, delayed-release (enteric) dosage forms comprising at least 90% by weight Z-endoxifen, with optional impurity limits (<2%), defined release characteristics in gastric and intestinal media, dose strengths (e.g., 1–4 mg and 8 mg), and pharmacokinetic performance targets (e.g., plasma exposures and steady-state levels). The claims also cover manufacturing methods that enrich the Z-isomer via stepwise crystallization and solvent control. These protections align with Atossa's quality-by-design approach to deliver a consistent, high-purity Z-endoxifen product.

In parallel, Atossa received a Certificate of Patent Renewal from the Israel Patent Office confirming fee payment and renewal status for Patent No. 304863, further supporting the life-cycle management of Z-endoxifen IP in this jurisdiction.

"Strong, durable patents are foundational to our Z-endoxifen strategy," said Steven Quay, M.D., Ph.D., Atossa Therapeutics Chairman and CEO. "This new protection in Israel, together with our broader global filings, covers what we believe are the critical elements of product quality, performance, and manufacturing needed to bring Z-endoxifen to patients and to create long-term value for shareholders."

About the Patent Scope in Israel
The granted patent includes: (i) enteric oral formulations with ≥90% Z-endoxifen; (ii) optional impurity and residual-solvent limits; (iii) stability and delayed-release attributes (acid resistance and intestinal release); (iv) dose ranges including 1–4 mg and 8 mg; (v) PK targets such as steady-state plasma levels and exposure ranges; and (vi) a multi-step crystallization process to enrich the Z-isomer. Collectively, these claims support Atossa's global protection for Z-endoxifen composition, performance, and process.

About Atossa Therapeutics
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative therapies for significant unmet needs in breast cancer. Atossa's strategy emphasizes disciplined capital allocation, focusing resources on programs and data packages that can enable future regulatory submissions and potential commercialization. For more information, visit www.atossatherapeutics.com and refer to Atossa's filings with the U.S. Securities and Exchange Commission (SEC).

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding Atossa's commercial readiness, financing strategy, operational plans, and the development and potential commercialization of (Z)-endoxifen. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including market conditions, regulatory outcomes, clinical results, manufacturing and supply, intellectual-property challenges, and the Company's ability to secure sufficient funding on acceptable terms. For a discussion of risks and uncertainties, please refer to Atossa's filings with the U.S. Securities and Exchange Commission. Atossa undertakes no obligation to update forward-looking statements, except as required by law.

Source Documents (Israel)

  • Certificate of Patent—No. 304863; Title: Methods for Making and Using Endoxifen; Filing 2018-09-10; Grant 2025-07-02; Priority to U.S. provisionals.
  • Certificate of Patent Renewal—No. 304863 (Israel Patent Office).
  • Allowed claims, including high-purity Z-endoxifen enteric formulations, release/PK attributes, and manufacturing steps.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/atossa-advances-global-patent-strategy-for-z-endoxifen-with-new-protection-in-israel-and-ongoing-renewals-302581338.html

SOURCE Atossa Therapeutics Inc

FAQ

What did Atossa (NASDAQ: ATOS) announce about Z-endoxifen patents on October 13, 2025?

Atossa announced an Israeli patent (No. 304863) granted July 2, 2025, plus a Certificate of Patent Renewal confirming active status.

What specific product attributes does the Israel patent No. 304863 claim for Z-endoxifen?

The patent claims enteric delayed-release oral dosage forms with ≥90% Z-endoxifen, optional impurity limits <2%, defined release profiles, and specified dose strengths.

How do the Israeli patent claims affect Atossa's Z-endoxifen manufacturing rights?

Claims include manufacturing methods to enrich the Z-isomer via stepwise crystallization and solvent control, supporting production quality protection.

When was the Israeli patent for Z-endoxifen granted and what is its priority timeline?

The patent was granted on July 2, 2025 with priority to multiple U.S. provisional applications filed in 2017–2018.

Does the announcement indicate ongoing global IP strategy for Atossa Z-endoxifen?

Yes; Atossa described this Israeli grant as part of broader multi-jurisdiction filings and renewals to support clinical and commercial plans.
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