ARS Pharmaceuticals Receives Favorable Decision from European Patent Office on Patent Related to neffy® (epinephrine nasal spray)
ARS Pharmaceuticals (NASDAQ: SPRY) announced the European Patent Office Opposition Division upheld all claims of EP 3678649, a patent covering nasal spray epinephrine formulations including alkyl-glycoside excipients such as Intravail®. The patent is validated in over 30 European countries and ARS states its global intellectual property for neffy provides coverage through at least 2039. Earlier in 2025 the USPTO also upheld key claims of U.S. Patent No. 10,682,414 after an IPR challenge and appeal, giving ARS two different patents with differing claim scope sustained in separate jurisdictions.
Company commentary framed the rulings as reinforcing the strength of its worldwide patent estate that covers intranasal epinephrine.
ARS Pharmaceuticals (NASDAQ: SPRY) ha annunciato che la Divisione di Opposizione dell'Ufficio Europeo dei Brevetti ha sostenuto tutte le rivendicazioni di EP 3678649, un brevetto che copre formulazioni di spray nasale di epinefrina inclusi eccipienti alkil-glucosi come Intravail®. Il brevetto è convalidato in oltre 30 paesi europei e ARS dichiara che la sua proprietà intellettuale globale per neffy offre copertura fino almeno al 2039. All'inizio del 2025 la USPTO ha anche sostenuto rivendicazioni chiave del Brevetto statunitense n. 10,682,414 dopo una sfida IPR e appello, fornendo ad ARS due brevetti differenti con ambiti di rivendicazione differenti sostenuti in giurisdizioni separate. La società ha commentato che le decisioni rafforzano la solidità del suo patrimonio mondiale di brevetti che copre l'epinefrina intranasale.
ARS Pharmaceuticals (NASDAQ: SPRY) anunció que la División de Opposición de la Oficina Europea de Patentes sostuvo todas las reivindicaciones de EP 3678649, una patente que cubre formulaciones de spray nasal de epinefrina que incluyen excipientes glucósidos alquílicos como Intravail®. La patente está validada en más de 30 países europeos y ARS afirma que su propiedad intelectual global para neffy cubre al menos hasta el 2039. A principios de 2025, la USPTO también sostuvo reivindicaciones clave de la Patente de EE. UU. No. 10,682,414 tras un desafío IPR y apelación, proporcionando a ARS dos patentes diferentes con alcance de reivindicación distinto sostenido en jurisdicciones separadas. La declaración de la empresa enmarca las decisiones como un refuerzo de la fortaleza de su cartera mundial de patentes que cubre la epinefrina intranasal.
ARS Pharmaceuticals (NASDAQ: SPRY)가 European Patent Office Opposition Division이 EP 3678649의 모든 청구항을 유지했다고 발표했고, 이 특허는 Intravail®와 같은 알킬 글라이코사이드 보조제를 포함하는 비충혈 완화제용 비강 스프레이 에피네프린 제형을 다룹니다. 이 특허는 30개가 넘는 유럽 국가에서 유효하며, neffy에 대한 ARS의 글로벌 지적 재산권은 2039년까지 최소 커버된다고 밝혔다. 2025년 초에는 USPTO가 미국 특허 No. 10,682,414의 핵심 청구항을 IPR 도전 및 항소 후에도 유지하여, ARS에게 서로 다른 청구범위를 가진 두 개의 특허를 서로 다른 법적 관할 구역에서 유지시켰다. 회사의 논평은 이러한 판단들이 비강 내 에피네프린을 다루는 전 세계 특허 포트폴리오의 강점을 강화한다고 말했다.
ARS Pharmaceuticals (NASDAQ: SPRY) a annoncé que la Division d'Opposition de l'Office européen des brevets a maintenu toutes les revendications de EP 3678649, un brevet couvrant les formulations de spray nasal d'épinéphrine comprenant des excipients glycosides alkyles tels que l'Intravail®. Le brevet est validé dans plus de 30 pays européens et ARS indique que sa propriété intellectuelle mondiale pour neffy couvre au moins jusqu'au 2039. Plus tôt en 2025, le USPTO a également maintenu des revendications clés du Brevet américain n° 10,682,414 après un défi IPR et un appel, offrant à ARS deux brevets différents avec des portées de revendication distinctes soutenues dans des juridictions distinctes. Les commentaires de l'entreprise ont encadré les décisions comme renforçant la solidité de son portefeuille mondial de brevets couvrant l'épinéphrine intranasale.
ARS Pharmaceuticals (NASDAQ: SPRY) gab bekannt, dass die Oppositionsabteilung des Europäischen Patentamts alle Ansprüche von EP 3678649 aufrechterhalten hat, ein Patent, das Nasenspray-Epinephrin-Formulierungen einschließlich Alkyl-Glucosid-Formulierungsadditiven wie Intravail® abdeckt. Das Patent ist in über 30 europäischen Ländern validiert und ARS erklärt, dass sein weltweites geistiges Eigentum für neffy einen Schutz bis mindestens 2039 bietet. Früh im Jahr 2025 bestätigte die USPTO auch wesentliche Ansprüche des US-Patents Nr. 10,682,414 nach einer IPR-Herausforderung und Berufung, wodurch ARS zwei verschiedene Patente mit unterschiedlichem Anspruchsumfang in getrennten Rechtsräumen bestehen. Die Unternehmenskommentare betonten, dass die Entscheidungen die Stärke des weltweiten Patentportfolios, das intranasale Epinephrin abdeckt, stärken.
ARS Pharmaceuticals (المدرجة في ناسداك: SPRY) أعلنت أن قسم المعارضة في المكتب الأوروبي للبراءات قد حافظ على جميع المطالبات لـ EP 3678649، وهي براءة تغطي تركيبات بخاخ الأنف للإيبينيفرين بما في ذلك معززات الإكسابتي alkyl-glycoside مثل Intravail®. تم اعتماد البراءة في أكثر من 30 دولة أوروبية وتذكر ARS أن ملكيتها الفكرية العالمية لـ neffy توفر حماية حتى 2039 على الأقل. في وقت مبكر من عام 2025، حافظت USPTO أيضًا على المطالبات الرئيسية للبراءة الأمريكية رقم 10,682,414 بعد تحدٍ من IPR واستئناف، مما منح ARS براءتين مختلفتين بنطاق مطالب مختلف مدعوم في ولايات قضائية منفصلة. ووردت تعليقات الشركة كإعادة تأكيد على قوة محفظتها العالمية من براءات الاختراع التي تغطي الإيبينيفرين الأنفي.
ARS Pharmaceuticals（纳斯达克股票代码：SPRY）宣布，欧洲专利局异议部维持了 EP 3678649 的全部权利要求，该专利涵盖包括 Intravail® 这样的烷基糖苷赋形剂在内的鼻腔喷雾肾上腺素制剂。该专利已在超过 30 个欧洲国家获得授权，ARS 表示其针对 neffy 的全球知识产权覆盖至少持续到 2039 年。2025 年初，USPTO 也在一次 IPR 及上诉后维持了美国专利号 10,682,414 的关键权利要求，使 ARS 在不同法域内获得了两项覆盖范围各异的专利。公司评论将这些裁决视为对其覆盖鼻内肾上腺素的全球专利资产力量的进一步强化。
- EPO upheld all claims of EP 3678649
- Patent validated in > 30 European countries
- Global IP coverage for neffy extends until at least 2039
- U.S. Patent No. 10,682,414 previously upheld after IPR and appeal
- None.
Insights
EPO upheld ARS Pharma's European patent claims for intranasal epinephrine, reinforcing its global IP estate through
EP 3678649 was unanimously upheld by the European Patent Office Opposition Division on
The business mechanism is clearer: upheld patents maintain exclusive claim scope in Europe and add overlap with a U.S. methods patent, which can limit rival entry and support commercialization leverage for the product described. The ruling directly preserves legal exclusion rights in over 30 European countries and complements the earlier U.S. outcome, increasing the number of independently defended patents across jurisdictions.
Dependencies and risks remain factual: future challenges could still occur, and commercial or regulatory developments could affect product value, but those events are not stated here. Watch for any announced licensing, litigation filings, or regulatory milestones tied to the patent estate, and monitor the listed patent coverage date (
SAN DIEGO, Oct. 08, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a commercial-stage biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, today announced the Opposition Division of the European Patent Office (the “EPO”) upheld the validity of all claims in EP 3678649, which is a patent validated in over 30 European countries directed to nasal spray epinephrine formulations including alkyl-glycoside, such as Intravail®, and uses thereof.
ARS Pharma’s issued global intellectual property portfolio related to neffy provides coverage until at least 2039.
Earlier this year, following successful defense of an Inter Partes Review (IPR) challenge and subsequent appeal proceedings, the United States Patent and Trademark Office formally upheld key claims for U.S. Patent No. 10,682,414, which is directed to methods of treating a type-1 hypersensitivity reaction, including anaphylaxis, using an epinephrine aqueous nasal spray.
Thus, two different ARS Pharma patents, with differing claim scope, have now been successfully upheld following two independent patent challenges in two different jurisdictions.
“The decisive and unanimous opinion of the EPO committee in rejecting all of the opposition arguments and upholding the novel claims in our European patent supports the strength and validity of our extensive patent portfolio,” said Richard Lowenthal Co-Founder, President and CEO of ARS Pharma. “These positive outcomes with our EP patent on top of the earlier IPR and Appeals court decisions on one of our U.S. methods of use patents, provide confidence in our ability to overcome future patent challenges to our worldwide patent estate that covers intranasal epinephrine.”
About neffy®
neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)
INDICATION
neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 33 lbs. or greater.
IMPORTANT SAFETY INFORMATION
neffy contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.
Always carry two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back.
Each neffy contains a single dose of epinephrine. neffy is for use in the nose only.
Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy.
Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed.
Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works.
neffy may cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you use neffy.
Common side effects of neffy include: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting.
Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy.
These are not all of the possible side effects of neffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information and Patient Information for neffy.
About Type I Allergic Reactions Including Anaphylaxis
Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency.
About ARS Pharmaceuticals, Inc.
ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy® (trade name EURneffy® in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients 4 years of age and older who weigh 15 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com.
Forward-Looking Statements
Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: beliefs about ARS Pharma’s patent portfolio; ARS Pharma’s belief in its ability to protect its patent portfolio; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “expects,” “if,” “intend,” “may,” “potential,” “plans,” “suggest,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications from neffy; the ability to maintain regulatory approval for neffy in its currently approved indications the scope, progress and expansion of developing and commercializing neffy; the potential for governments and payors to delay, limit or deny coverage for neffy; the size and growth of the market for neffy and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharma’s ability to protect its intellectual property position; and the impact of government laws, regulations and policies.
Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharma’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission on August 13, 2025. These documents can also be accessed on ARS Pharma’s website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.
The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visit www.ars-pharma.com, and follow us on LinkedIn and X.
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FAQ
What did ARS Pharmaceuticals (SPRY) announce on October 8, 2025 about EP 3678649?
How long does ARS say its neffy intellectual property will provide protection for SPRY shareholders?
How does the EPO decision relate to ARS's U.S. patent position for SPRY?
Does the EPO decision affect neffy market exclusivity for SPRY in Europe?
Will the EPO ruling stop future patent challenges against SPRY?
Which formulations does EP 3678649 cover according to ARS (SPRY)?
