Aytu BioPharma Announces Patent Term Extension for EXXUA(TM)
Aytu BioPharma (Nasdaq: AYTU) announced that the U.S. method‑of‑use patent (U.S. Patent No. 7,538,116) for EXXUA (gepirone) extended‑release tablets was extended under 35 U.S.C. 156 through September 2, 2030. The extension supplements the NCE exclusivity previously granted by the FDA for gepirone, described as the first‑in‑class selective serotonin 5HT1a receptor agonist approved for treatment of major depressive disorder (MDD) in adults.
Management said EXXUA is on track for commercial launch in 2025 and that the company is discussing additional intellectual property and life‑cycle management options with its partner that may extend exclusivity beyond 2030. The release also cites an estimated 21 million Americans affected by MDD as the target patient population.
Aytu BioPharma (Nasdaq: AYTU) ha annunciato che il brevetto statunitense sull'uso (U.S. Patent No. 7,538,116) per EXXUA (gepirone) compresse a rilascio esteso è stato prorogato ai sensi del 35 U.S.C. 156 fino al 2 settembre 2030. L'estensione integra la esclusività NCE precedentemente concessa dalla FDA per gepirone, descritta come il primo agonista selettivo del recettore serotoninergico 5HT1a approvato per il trattamento della disturbo depressivo maggiore (MDD) negli adulti.
La direzione ha dichiarato che EXXUA è in pista per il lancio commerciale nel 2025 e che l'azienda sta discutendo ulteriori opzioni di proprietà intellettuale e gestione del ciclo di vita con il suo partner che potrebbero prolungare l'esclusività oltre il 2030. Il comunicato cita anche una popolazione di pazienti stimata di 21 milioni di americani affetti da MDD.
Aytu BioPharma (Nasdaq: AYTU) anunció que la patente estadounidense de uso método de uso (U.S. Patent No. 7,538,116) para EXXUA (gepirona) tabletas de liberación extendida fue extendida conforme al 35 U.S.C. 156 hasta 2 de septiembre de 2030. La extensión complementa la exclusividad NCE concedida previamente por la FDA para la gepirona, descrita como la primera agonista selectivo del receptor de serotonina 5HT1a de clase en ser aprobada para el tratamiento del trastorno depresivo mayor (MDD) en adultos.
La dirección dijo que EXXUA está en camino para el lanzamiento comercial en 2025 y que la compañía está discutiendo opciones adicionales de propiedad intelectual y gestión del ciclo de vida con su socio que podrían ampliar la exclusividad más allá de 2030. El comunicado también cita una población de pacientes objetivo estimada de 21 millones de estadounidenses afectados por el MDD.
Aytu BioPharma (Nasdaq: AYTU) 미국의 사용방법 특허(미국 특허 번호 7,538,116)가 EXXUA(gepirone) 서방형 정제에 대해 35 U.S.C. 156에 따라 2030년 9월 2일까지 연장되었다고 발표했다. 이 연장은 gepirone에 대해 FDA가 이전에 부여한 NCE 독점권을 보완하며, 성인에서 주요 우울장애(MDD) 치료에 승인된 첫 번째 계열의 선택적 세로토닌 5HT1a 수용체 작용제라고 설명된다.
경영진은 EXXUA가 2025년 상업적 출시를 위한 궤도에 있다고 밝히며, 회사가 파트너와 함께 2030년 이후의 독점권을 연장할 수 있는 추가 지적 재산권 및 생애 주기 관리 옵션에 대해 논의하고 있다고 밝혔다. 또한 발표는 대상 환자군으로 추정되는 2100만 명의 미국인이 MDD에 영향을 받는다고 인용한다.
Aytu BioPharma (Nasdaq: AYTU) a annoncé que le brevet américain sur l’usage (U.S. Patent No. 7,538,116) pour EXXUA (gépirone) comprimés à libération prolongée a été prorogé en vertu du 35 U.S.C. 156 jusqu’au 2 septembre 2030. Cette prolongation vient compléter l'exclusivité NCE précédemment accordée par la FDA pour la gepirone, décrite comme le premier agoniste sélectif du récepteur sérotoninergique 5HT1a approuvé pour le traitement du trouble dépressif majeur (TDM) chez les adultes.
La direction a déclaré que EXXUA est en bonne voie pour un lancement commercial en 2025 et que l’entreprise discute avec son partenaire d’options supplémentaires de propriété intellectuelle et de gestion du cycle de vie qui pourraient prolonger l’exclusivité au-delà de 2030. Le communiqué cite également une population de patients estimée à 21 millions d’Américains atteints de MDD.
Aytu BioPharma (Nasdaq: AYTU) gab bekannt, dass das US‑Patent für die Nutzungs‑Patente (U.S. Patent No. 7,538,116) für EXXUA (Geprion) Extended‑Release Tabletten gemäß 35 U.S.C. 156 bis zum 2. September 2030 verlängert wurde. Die Verlängerung ergänzt die NCE‑Exklusivität, die zuvor von der FDA für Gepiron gewährt wurde, beschrieben als der erste seiner Klasse selektiver Serotonin‑5HT1a‑Rezeptoragonist, der zur Behandlung von major depressive disorder (MDD) bei Erwachsenen zugelassen ist.
Das Management sagte, dass EXXUA auf dem Weg zum kommerziellen Markteintritt im Jahr 2025 sei und dass das Unternehmen mit seinem Partner über zusätzliche geistige Eigentumsrechte und Lebenszyklus‑Management‑Optionen spreche, die die Exklusivität über 2030 hinaus verlängern könnten. Die Mitteilung nennt außerdem eine geschätzte Zielpatientenpopulation von 21 Millionen Amerikanern, die von MDD betroffen sind.
Aytu BioPharma (Nasdaq: AYTU) أعلنت أن براءة الاستخدام الأمريكية لطرق الاستخدام (U.S. Patent No. 7,538,116) لـ EXXUA (gepirone) أقراص إطلاق مطول قد تم تمديدها بموجب 35 U.S.C. 156 حتى 2 سبتمبر 2030. ويُكمل هذا التمديد حصرية NCE التي منحتها FDA سابقًا لـ gepirone، والتي وُصِفت بأنها أول منبه مستقبلات السيروتونين 5HT1a انتقائية معتمد لعلاج الاضطراب الاكتئابي الشديد (MDD) لدى البالغين.
وقالت الإدارة إن EXXUA في المسار للإطلاق التجاري في 2025 وأن الشركة تناقش خيارات إضافية للملكية الفكرية وإدارة دورة الحياة مع شريكها التي قد تمدد الحصرية إلى ما بعد 2030. كما يشير البيان إلى تقدير بأن 21 مليون أميركي مصاب بـ MDD كفئة مستهدفة من المرض.
Aytu BioPharma (Nasdaq: AYTU) 宣布，美国的用途专利（美国专利号 7,538,116）适用于 EXXUA（地皮罗酮）缓释片，根据 35 U.S.C. 156 延长至 2030 年 9 月 2 日。此次延长期补充了 FDA 先前授予 geprion 的 NCE 独占权，该独占权被描述为第一批用于成年人治疗 重度抑郁障碍（MDD） 的5HT1a 受体选择性激动剂。
管理层表示 EXXUA 正 按计划于 2025 年实现商业上市，公司也在与其合作伙伴就额外的知识产权和生命周期管理选项进行讨论，这些选项可能将独占权延长至 2030 以后。公告还引用一个估计的 2100 万名受 MDD 影响的美国人 作为目标患者人群。
- Patent extended through September 2, 2030 under 35 U.S.C. 156
- NCE exclusivity in place for gepirone (EXXUA)
- FDA approval for EXXUA as first‑in‑class 5HT1a agonist for MDD
- Commercial launch on track for 2025
- Exclusivity currently expires on September 2, 2030
- Commercial revenue not yet realized—launch pending in 2025
- Further exclusivity depends on partner discussions and lifecycle actions
Insights
Patent extension to
The company secured an extension of U.S. Patent No. 7,538,116 under 35 U.S.C. 156 through
Key dependencies and risks mentioned are constrained to items in the release: continuation of partner discussions to expand intellectual property and successful execution of the planned commercial launch in
Watch the commercial launch timing in
DENVER, CO / ACCESS Newswire / October 28, 2025 / Aytu BioPharma, Inc. (the "Company" or "Aytu") (Nasdaq:AYTU), a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients, today announced that the method of use patent (U.S. Patent No. 7,538,116) for EXXUATM (gepirone) extended-release tablets ("EXXUA") has been extended through September 2, 2030 under 35 U.S.C. 156. The patent extension further expands upon the new chemical entity ("NCE") exclusivity period granted by the United States Food and Drug Administration ("FDA"). Gepirone is an NCE, and EXXUA is the first-in-class selective serotonin 5HT1a receptor agonist approved by the FDA for the treatment of major depressive disorder ("MDD") in adults.
"We are very pleased that the EXXUA patent has been granted this five year extension which adds to the exclusivity beyond that normally provided by the NCE approval," commented Josh Disbrow, Chief Executive Officer of Aytu. "Further, we continue to engage in discussions with our partner to expand upon the existing intellectual property through various potential life cycle management approaches, which may extend exclusivity beyond 2030."
"EXXUA is on track to be commercially launched in 2025. Its novel product profile is expected to be an important treatment option to help address the unmet needs of the estimated 21 million Americans affected by MDD."
"Although progress has been made in depression treatments, challenges like treatment-related sexual dysfunction and weight gain remain significant drawbacks for many MDD therapies," Disbrow continued. "We believe EXXUA will be a crucial option for doctors treating the millions of patients with MDD in the United States," Disbrow concluded.
About Aytu BioPharma
Aytu is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients. The Company's prescription products include EXXUA™ (gepirone) extended-release tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of major depressive disorder (MDD), Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD), and a line of legacy products, including Karbinal® ER (carbinoxamine maleate), Poly-Vi-Flor® and Tri-Vi-Flor®. To learn more, please visit aytubio.com.
About EXXUA
EXXUA is a novel oral selective serotonin 5HT1a receptor agonist indicated for the treatment of major depressive disorder (MDD) in adults. EXXUA is also being developed for other psychiatric disorders.
INDICATIONS and IMPORTANT SAFETY INFORMATION for EXXUA
INDICATIONS
EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults.
IMPORTANT SAFETY INFORMATION
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors.
EXXUA is not approved for use in pediatric patients.
Do not take EXXUA if you:
are allergic to EXXUA or any of the ingredients in EXXUA.
have a prolonged QTc interval greater than 450 msec or congenital long QT syndrome.
are taking medicines known as strong CYP3A4 inhibitors. Ask your healthcare provider if you are not sure if you are taking one of these medicines.
have severe liver problems.
are taking, or have stopped taking within the last 14 days, a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue.
Do not start taking an MAOI for at least 14 days after you have stopped treatment with EXXUA.
EXXUA may cause serious side effects, including:
Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and will also do blood tests to check your levels of body salts (electrolytes) before and during treatment with EXXUA. Your healthcare provider may check your electrolytes more often during treatment if you have heart failure, a slow heart rate, abnormal levels of electrolytes in your blood, or if you take other medications that can prolong the QT interval of your heartbeat.
A potentially life-threatening problem called serotonin syndrome can happen when EXXUA is taken with certain other medicines.
Manic episodes may happen in people with bipolar disorder who take EXXUA.
Please read FULL PRESCRIBING INFORMATION for EXXUA.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended ("Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended ("Exchange Act"). All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as "may," "will," "should," "forecast," "could," "expect," "suggest," "believe," "estimate," "continue," "anticipate," "intend," "plan," or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this press release, are forward-looking statements. These statements are predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others, risks associated with: the Company's overall financial and operational performance, potential adverse changes to the Company's financial position or our business, the results of operations, strategy and plans, changes in capital markets and the ability of the Company to finance operations in the manner expected, risks relating to gaining market acceptance of our products, our partners performing their required activities, our anticipated future cash position, regulatory and compliance challenges and future events under current and potential future collaborations. We also refer you to (i) the risks described in "Risk Factors" in Part I, Item 1A of our most recent Annual Report on Form 10‑K and in the other reports and documents we file with the United States Securities and Exchange Commission.
Contacts for Investors
Ryan Selhorn, Chief Financial Officer
Aytu BioPharma, Inc.
rselhorn@aytubio.com
Robert Blum
Lytham Partners
aytu@lythampartners.com
SOURCE: Aytu BioPharma, Inc.
View the original press release on ACCESS Newswire
FAQ
What patent change did Aytu announce for EXXUA (AYTU) on October 28, 2025?
How does the patent extension affect EXXUA's FDA exclusivity for AYTU?
When is EXXUA (gepirone) expected to launch commercially for AYTU?
What indication is EXXUA approved for and what class is it for AYTU?
Does Aytu expect exclusivity beyond 2030 for EXXUA (AYTU)?
How large is the U.S. patient population Aytu cited for EXXUA (AYTU)?
