Highlights:
- ARS Pharmaceuticals launched neffy in November 2025, the first FDA-approved needle-free nasal epinephrine for anaphylaxis, offering injectable-level effectiveness with faster, easier use and a longer shelf life.
- ARS Pharmaceuticals became a commercial-stage business in 2025, backed by major healthcare investors and up to $250 million in financing to accelerate neffy’s global rollout.
- ARS Pharma’s patents protect its intranasal delivery technology, covering optimized formulations and methods that differentiate neffy in emergency allergy care.
ARS Pharmaceuticals launched neffy in November 2025, introducing the first nasal treatment for anaphylaxis approved by the FDA. The product delivers a single dose of epinephrine through one nostril and represents a significant shift in how patients can respond to severe allergic reactions.
Neffy serves as ARS Pharma’s flagship product and is indicated for emergency anaphylaxis treatments in adults and children aged four and older who weigh at least 33 lbs. It provides epinephrine levels comparable to injectables products while offering rapid administration, portability, and long shelf life (2.5 years for 2 mg dose and 2 years for the 1 mg dose). In Europe, where it is marketed as EURneffy, it is the first and only needle-free emergency epinephrine product.
Backed by sector-focused healthcare investors such as RA Capital Management and OMERS Life Sciences, ARS Pharma advanced from a development-stage startup to a commercial-stage company by 2025. On September 29, 2025, the company obtained a senior secured term loan facility of up to $250 million from RA Capital Management and an affiliate of OMERS Life Sciences, including an initial $100 million investment. The financing is being deployed to accelerate Neffy’s commercial rollout.
A new approach to anaphylaxis
Severe allergies and anaphylaxis cases are rising globally, driving demand for emergency solutions that are faster, easier to use, and more reliably accessible. Use of epinephrine auto-injectors has long faced practical problems, including high cost, complicated devices, fear of needles, people not carrying or using them correctly, and delays during real emergencies, leaving many patients at risk even though guidelines recommend giving epinephrine immediately.
In this context, neffy is more than just a new epinephrine product. It addresses long-standing problems with ease of use and access, helping patients get fast, effective treatment when anaphylaxis strikes.
Needle-free innovation
ARS Pharma, founded in 2015, is focused on developing ARS-1 (now neffy), a needle-free intranasal epinephrine option for the emergency treatment of Type I allergic reactions and anaphylaxis. The company was established by Richard Lowenthal with Sarina Tanimoto, Robert Bell and other clinical collaborators.
ARS Pharma competes in the epinephrine market alongside entrenched auto-injector brands such as EpiPen, Auvi-Q, and generics. The company maintains its edge by offering the only needle-free epinephrine option, securing broad payor access, driving adoption through direct-to-consumer campaigns, and expanding internationally. Strong prescriber uptake and global regulatory wins continue to differentiate neffy in a historically stagnant market.
In the next sections, we examine ARS Pharma’s patent strategy and portfolio, highlighting how intellectual property supports Neffy’s market leadership and innovation.
ARS Pharma: Patenting Activity
The patent portfolio of ARS Pharma is significantly most active in 2018. That year, they were able to raise $20 million in Series C financing with the help of Deerfield Management. Additionally in June 2018, they secured exclusive global rights from Aegis Therapeutics to use proprietary technology, patents, and know-how for developing and commercializing epinephrine products.
ARS Pharma: Top Technology
ARS Pharma’s patent fillings are highly concentrated in two technology areas: medical preparation purposes (A61K) at 44.1% and therapeutic activity of chemical compounds or medicinal preparations (A61P) at 40.7%. This dominance reflects ARS Pharma’s positioning as a leader in the intranasal epinephrine treatment with neffy.
The rest of the portfolio spans to other technologies, with peptides (C07K), acyclic, carbocyclic or heterocyclic compounds (C07F), and heterocyclic compounds (C07D) driving their other healthcare focus in liver and cancer treatments. These assets were largely acquired through a merger with Silverback Therapeutics in November 2022.
ARS Pharma: Top Law Firms
Globally, ARS Pharma was primarily represented by attorneys Jin-Hoe Kim and Terry Taehong Kim from Lee International, particularly for Korean patent filings. Other primary representatives are from Mewburn Ellis handling filings in the European region. Patent filings in Australia were handled by attorneys from FB Rice.
In the U.S., they are closely working with Wilson Sonsini Goodrich & Rosati for their IP activities. This includes a senior secured loan from RA Capital Management and an affiliate of OMERS Life Sciences. Valentin Zunic together with Mike Hostetler and Kaia Parenti are the main correspondents of ARS Pharma from the firm.
Patents activating neffy
With neffy now commercially available, we take a look at some of the patents that protect ARS Pharma’s intellectual property. Together, these innovations form the backbone of the company’s technological advantage, positioning ARS Pharma as the clear leader in intranasal epinephrine development and delivery.
Optimized intranasal therapeutic formulations
Many therapeutic agents, including peptides and proteins, suffer from poor stability and low absorption. These limitations make safe, efficient, and noninvasive drug delivery extremely difficult.
U.S. Patent No. 10,576,156 overcomes these challenges by engineering a formulation that preserves sensitive molecules and enhances their transport across mucosal tissues. It combines optimized pH, protective excipients, and absorption-enhancing agents to maintain drug integrity while enabling rapid, reliable uptake. This coordinated design allows effective delivery without injections, reducing complexity and improving patient accessibility. The patent identifies and integrates a specific set of formulation parameters and delivery conditions.
The patent, titled “Compositions for drug administration,” was filed on February 6, 2018, and was published on March 3, 2020. The patent lists Edward T. Maggio as its inventor. Legal representation was provided by DLA Piper LLP.
Anaphylaxis treatment through intranasal epinephrine
Administering epinephrine during allergic emergencies requires immediate action, but current delivery methods are often complicated and difficult to use correctly. Patients must act under stress, yet existing devices demand precise handling and proper positioning, which can easily lead to mistakes.
U.S. Patent No. 10,682,414 patent addresses limitations of existing epinephrine delivery by providing an intranasal formulation that achieves rapid, reproducible systemic absorption without needle administration. By optimizing dose, pH, and inclusion of absorption enhancers, the invention ensures plasma concentrations comparable to intramuscular injections while maintaining stability and tolerability.
The patent provides a precise combination of formulation parameters and delivery method, enabling effective, user-friendly, and needle-free emergency treatment of anaphylaxis. This system overcomes the challenges of auto-injector variability and patient compliance.
The patent, titled “Intranasal epinephrine formulations and methods for the treatment of disease,” was filed on May 22, 2019, and published on June 16, 2020. Inventors listed in the patent include Richard Lowenthal, Edward T. Maggio, Robert G. Bell, and Pratik Shah. Legal representation was provided by DLA Piper LLP.
Enhanced formulation for epinephrine nasal spray
The U.S. Pat. App. Pub. No. 2025/0262173 is highly similar to the ‘414 patent. However, the patent application explores optimized pharmacokinetics, chemical stability, and absorption enhancers formulation. This patent also aims to enable rapid, reliable, and patient-friendly systemic epinephrine delivery during type-1 hypersensitivity reactions.
The patent application, titled “Intranasal epinephrine formulations and methods of use,” was filed on February 18, 2025, and was published on August 21, 2025. The application lists Richard Lowenthal as the inventor. The legal team from Wilson Sonsini Goodrich & Rosati represented ARS Pharma in the filing of this patent application.
Collectively, the patents reveal the scientific backbone behind neffy and signal how ARS Pharma aims to hold its ground as the fight for market share in emergency allergy care intensifies.
