United States Patent 10,682,414: Scope, Claims, Exclusivity, and Intranasal Epinephrine Patent Landscape

U.S. Patent No. 10,682,414 protects methods of treating type-1 hypersensitivity reactions by administering an aqueous intranasal epinephrine formulation. Its commercial relevance is strongest for Neffy, ARS Pharmaceuticals’ intranasal epinephrine product. The patent is method-of-treatment coverage, not a pure composition or device patent. Its most commercially significant claim set combines a single intranasal dose of 0.4 mg to 2.4 mg epinephrine with absorption enhancers, EDTA, sodium chloride, controlled pH, and delivery of approximately 100 microliters per actuation.

The claims reach the core clinical and formulation architecture of an intranasal epinephrine product. They do not require every excipient in every claim, but the dependent claims narrow protection around formulations that substantially correspond to the marketed product.

What does U.S. Patent 10,682,414 protect?

Patent 10,682,414 protects a treatment method requiring five principal elements:

A mammal has a type-1 hypersensitivity reaction or requires treatment for anaphylaxis.
The product is administered intranasally.
The product is an aqueous nasal spray formulation.
The active ingredient is epinephrine or an epinephrine salt.
The single dose contains a specified quantity of epinephrine.

The independent claim does not require a particular absorption enhancer, device, pH, excipient, or volume. That gives claim 1 broad coverage across aqueous intranasal epinephrine products containing approximately 0.1 mg to 2.4 mg per dose.

Claim architecture

Claim group	Principal limitation	Commercial significance
Claim 1	Intranasal aqueous epinephrine, 0.1 mg to 2.4 mg per dose, for type-1 hypersensitivity	Broadest method claim
Claim 2	Specified allergic conditions and 0.4 mg to 2.4 mg per dose	Covers anaphylaxis and related allergic diseases
Claims 3-6	Plasma exposure efficacious for anaphylaxis; dose ranges from 0.5 mg to 1.5 mg; selected dose bands	Links the method to pharmacodynamic performance
Claim 4	Approximately 100 microliters delivered in one actuation	Targets commercial nasal-spray presentation
Claims 7-11	Absorption enhancers, including dodecyl maltoside, benzalkonium chloride, oleic acid, polysorbates, and sodium lauryl sulfate	Formulation-specific protection
Claims 12-17	Sodium chloride, EDTA, preservatives, and pH of approximately 2.0 to 6.0	Protects formulation design and stability parameters
Claims 18-20	Narrow combinations of epinephrine, dodecyl maltoside, benzalkonium chloride, EDTA, sodium chloride, water, and controlled pH	Closest claims to the marketed product

How broad is claim 1 of patent 10,682,414?

Claim 1 is materially broader than the dependent formulation claims. It covers any method satisfying the dose, route, dosage-form, and therapeutic-use limitations, even if the formulation uses a different absorption enhancer or no expressly claimed enhancer.

The claim has several potential boundaries:

It requires an aqueous formulation.
It requires intranasal administration.
It requires epinephrine or an epinephrine salt.
It requires approximately 0.1 mg to 2.4 mg in a single dose.
It requires treatment of a type-1 hypersensitivity reaction in a mammal.

A dry-powder nasal product, a nonaqueous formulation, or a product outside the stated dose range would have a stronger noninfringement position against claim 1. A product using the same route and dose but a different excipient system could still face claim 1 even if it avoided claims 7 through 20.

The phrase “consists of” in the active-ingredient limitation narrows the active ingredient to epinephrine or its salt within the specified amount. It does not necessarily exclude inactive ingredients, provided the formulation otherwise meets the claim.

What formulations are protected by the dependent claims?

Claims 7 through 20 create a layered formulation estate. The claims cover broad excipient classes first, then progressively narrower concentration ranges and ingredient combinations.

Absorption-enhancer coverage

The principal absorption enhancers are:

Dodecyl maltoside
Benzalkonium chloride
Oleic acid or an oleate salt
Polysorbate 20
Polysorbate 80
Sodium lauryl sulfate

Claim 9 is narrower than claim 8 because it focuses on dodecyl maltoside, benzalkonium chloride, oleic acid, and combinations of those ingredients. Claim 10 adds concentration ranges, including:

Dodecyl maltoside: approximately 0.005% to 2.5% w/v
Benzalkonium chloride: approximately 0.001% to 1% w/v
Oleic acid or salt: approximately 0.001% to 1% w/v

Claim 11 is commercially important because it focuses on benzalkonium chloride concentrations between approximately 0.005% and 0.08% w/v, with narrower subranges of 0.01% to 0.06% and 0.01% to 0.04%. The claim allows benzalkonium chloride to be the sole absorption enhancer or to be used with other enhancers.

Stabilization and pH

Claims 13 and 14 cover EDTA, particularly disodium EDTA at approximately 0.001% to 1% w/v. Claims 16 and 17 cover formulations adjusted to a pH between approximately 2.0 and 6.0 using an acid, base, buffer, or combination.

The pH limitations may be important in formulation litigation because a competing product could attempt to avoid the narrower claims by using a pH outside the claimed range. That strategy would not necessarily avoid claim 1, which has no express pH limitation.

Narrowest commercial formulation claims

Claims 18 through 20 require combinations that are substantially aligned with a commercial intranasal epinephrine formulation:

Epinephrine
Dodecyl maltoside
Benzalkonium chloride
EDTA or an EDTA salt
Sodium chloride
Water
Optional pH-adjusting agents
pH between approximately 2.0 and 6.0, or 3.0 and 5.0
Approximately 100 microliters per actuation in claim 20

These claims provide a direct formulation-based infringement theory against a product that copies the same excipient system and delivery volume.

How does patent 10,682,414 relate to Neffy?

Neffy is an aqueous intranasal epinephrine spray developed by ARS Pharmaceuticals. The FDA approved Neffy 2 mg in August 2024 for emergency treatment of allergic reactions, including anaphylaxis, in adults and pediatric patients weighing at least 30 kilograms. FDA later expanded the product’s use to a 1 mg strength for pediatric patients weighing 15 to less than 30 kilograms. [1]

Neffy’s publicly described formulation includes epinephrine, dodecyl maltoside, benzalkonium chloride, disodium EDTA, sodium chloride, water, and pH-adjusting agents. The product is delivered as a single 100-microliter nasal spray. Those characteristics correspond closely to claims 18 through 20. [2]

Neffy characteristic	Relevant patent limitation
Intranasal administration	Claims 1-20
Aqueous formulation	Claims 1-20
Epinephrine active ingredient	Claims 1-20
1 mg or 2 mg dose presentations	Claims 1-6, 18-20
Approximately 100 microliters per spray	Claims 4 and 20
Dodecyl maltoside	Claims 8-11, 18-20
Benzalkonium chloride	Claims 8-11, 15, 18-20
EDTA	Claims 13, 14, 18-20
Sodium chloride	Claims 12, 18-20
Controlled acidic pH	Claims 16-20

The patent’s claim coverage is therefore strongest against an intranasal epinephrine product that uses the same formulation strategy and dosage presentation. A competitor that changes the enhancer system may reduce exposure to claims 8 through 20 but could remain exposed to the broad method claims.

When does patent 10,682,414 lose exclusivity?

The patent’s nominal term is governed by the earliest effective nonprovisional filing date of its patent family, subject to any patent-term adjustment, terminal disclaimer, patent-term extension, or other statutory adjustment. Public patent records identify the patent as part of ARS Pharmaceuticals’ intranasal epinephrine family. The expected unadjusted family term runs into the mid-2030s. [3]

The patent expiry date should be distinguished from FDA regulatory exclusivity:

Patent expiry is controlled by Title 35 patent-term rules.
New-drug exclusivity is controlled by the Federal Food, Drug, and Cosmetic Act.
Orange Book listing creates a Hatch-Waxman framework for an ANDA applicant that certifies against the listed patent.
Patent expiry does not automatically establish FDA approval timing for a generic product.

Neffy’s five-year new chemical entity exclusivity is separate from the patent term. Because Neffy contains epinephrine, the FDA’s regulatory-exclusivity analysis may depend on whether the approved product qualified for a new chemical entity period or another exclusivity category. The FDA Orange Book, approval letter, and product-specific exclusivity record control that question. [1, 4]

What is the Orange Book status of patent 10,682,414?

A patent covering an approved drug may be listed in the FDA Orange Book if it claims the drug substance, drug product, or an approved method of use and satisfies FDA listing requirements. Patent 10,682,414 is relevant to Orange Book analysis because its claims cover an approved method of using an intranasal epinephrine product and narrow formulation implementations associated with Neffy.

The commercial consequences of listing are significant:

An ANDA applicant may submit a Paragraph IV certification.
The patent holder may sue within 45 days.
A timely infringement action can trigger a 30-month stay of ANDA approval under Hatch-Waxman.
The stay may terminate earlier through court action, settlement, patent delisting, or other statutory events.
A generic applicant may seek approval after patent expiry or after prevailing in litigation.

Orange Book listing must be confirmed against the current FDA database because listing status, use codes, delisting, and patent-term dates can change. [4]

Which companies are likely to challenge the Neffy patent estate?

The principal competitive threat is from generic-drug companies with nasal-spray development and ANDA capabilities. A challenger could pursue one of four routes:

File an ANDA for the same or substantially similar product.
Submit a Paragraph IV certification against listed patents.
Design around the narrower formulation claims.
Develop a different intranasal epinephrine formulation and seek approval through a regulatory pathway that does not rely on the reference product in the same manner.

The most important design-around variables are:

Dose per actuation
Spray volume
Absorption enhancer
Preservative system
EDTA concentration
pH
Device architecture
Number of actuations
Pharmacokinetic profile

A product using a nonaqueous or dry-powder formulation could avoid several claims but would face separate technical and regulatory development requirements. A liquid aqueous spray using epinephrine at 1 mg or 2 mg remains closer to the commercial target and faces the highest claim-overlap risk.

Is there biosimilar risk for patent 10,682,414?

There is no biosimilar risk in the conventional statutory sense. Epinephrine is a small-molecule active ingredient, and competing products would generally be evaluated as generic drugs or new drug applications rather than biosimilars under the Public Health Service Act.

The relevant competitive pathway is an ANDA or, for a materially different formulation or device, a 505(b)(2) application. The patent estate can affect both pathways, although the procedural posture differs:

Pathway	Typical product	Patent relevance
ANDA	Generic equivalent intranasal epinephrine	Paragraph IV and Orange Book litigation
505(b)(2) NDA	Different formulation, device, or clinical presentation	Listed-patent certifications and possible litigation
Biologics license application	Not applicable to epinephrine	No conventional biosimilar route

How strong is the patent estate?

The estate is strongest in three areas.

Broad route-and-dose protection

Claims 1 through 6 cover the central concept of treating allergic reactions with aqueous intranasal epinephrine at clinically relevant doses. A challenger cannot avoid those claims merely by changing an excipient.

Product-specific formulation protection

Claims 18 through 20 map closely to the commercial formulation and 100-microliter delivery format. They provide a stronger product-identification theory than the broad method claims.

Pharmacokinetic limitation

Claim 3 requires a plasma epinephrine concentration efficacious for treating anaphylaxis. This limitation may create factual disputes concerning pharmacokinetic testing, clinical efficacy, dose proportionality, and the meaning of “efficacious.” It can strengthen validity arguments by tying the claim to therapeutic performance, but it may also create proof issues in an infringement action.

The principal weaknesses are claim breadth and potential prior-art exposure. Earlier patents and publications concerning intranasal sympathomimetics, epinephrine absorption, nasal permeation enhancers, preservatives, and aqueous spray formulations could be relevant to novelty and obviousness. The patent’s defensibility will depend on the prosecution history, cited references, expert interpretation of the pharmacokinetic limitation, and whether the specific combination produced an unexpected clinical or absorption result. [3]

What litigation and settlement issues matter?

A generic challenge would likely focus on:

Invalidity based on obviousness over intranasal epinephrine and nasal absorption-enhancer references
Written-description and enablement issues for the broad dose range
Construction of “efficacious for the treatment of anaphylaxis”
Construction of “about” for dose, concentration, pH, and volume
Whether the accused product practices the claimed method
Whether a generic label induces infringement
Whether formulation changes avoid claims 18 through 20

Any settlement could include a deferred generic launch date, a license, a covenant not to sue, or restrictions tied to particular formulations. A settlement’s commercial value would depend on the authorized-generic structure, launch date, scope of the license, and treatment of later-issued continuation patents.

A complete litigation assessment requires the current PACER docket, FDA Orange Book entries, patent-family records, and any Paragraph IV notices. Those materials are not contained in the claim text supplied here.

How does the patent compare with injectable epinephrine products?

Patent 10,682,414 covers a delivery platform rather than the traditional injectable epinephrine market.

Product category	Main delivery route	Principal competitive issue
EpiPen and authorized generics	Intramuscular injection	Device price, substitution, training
Auvi-Q	Intramuscular injection	Device design and user guidance
Symjepi	Prefilled syringe injection	Cost and device simplicity
Neffy	Intranasal spray	Needle-free administration and rapid access
Future intranasal generics	Intranasal spray	Formulation equivalence and patent clearance

The patent does not prevent injectable epinephrine competition. Its value depends on preserving exclusivity around the nasal route, formulation, and dose.

Key Takeaways

Patent 10,682,414 is a method-of-treatment patent for aqueous intranasal epinephrine.
Claim 1 is broad and does not require a particular absorption enhancer or excipient.
Claims 18 through 20 are the closest match to Neffy’s disclosed formulation and 100-microliter spray presentation.
The estate covers dose, route, formulation, absorption enhancement, EDTA stabilization, sodium chloride, pH, and delivery volume.
Epinephrine has no conventional biosimilar pathway; generic and 505(b)(2) challenges are the relevant risks.
A competitor may reduce exposure to narrow formulation claims by changing the enhancer, pH, device, volume, or dosage form, but may remain exposed to broad route-and-dose claims.
Patent expiry is expected in the mid-2030s based on the underlying family term, subject to patent-term adjustment and other statutory modifications.
Orange Book listings, Paragraph IV certifications, litigation, and settlement terms must be assessed from current FDA and court records rather than the claims alone.

FAQs

Does patent 10,682,414 cover all epinephrine nasal sprays?

No. It covers aqueous intranasal epinephrine methods within the claimed dose ranges and therapeutic uses. Nonaqueous, dry-powder, or out-of-range products may avoid some or all claims, depending on their full design.

Can a generic avoid the patent by removing dodecyl maltoside?

Possibly, but removing dodecyl maltoside would primarily affect the narrower formulation claims. The generic could still face claim 1 and other claims if it uses an aqueous intranasal epinephrine formulation within the claimed dose range.

Does the patent cover a second nasal spray dose?

The claims focus on a single dose, but a treatment regimen involving repeat administration could still raise infringement issues if each administered dose satisfies the claimed method. The product label and actual use instructions would be important.

Does patent 10,682,414 cover epinephrine auto-injectors?

No. The claims require intranasal administration of an aqueous nasal spray. Injectable products do not satisfy that route limitation.

What is the main invalidity risk for this patent?

The principal risk is an obviousness challenge based on prior art combining intranasal epinephrine with known nasal absorption enhancers and conventional formulation excipients. The strength of the patent would turn on the prior-art combinations, prosecution history, and evidence supporting the claimed therapeutic plasma exposure.

References

U.S. Food and Drug Administration. (2024). FDA approves first nasal spray for emergency treatment of allergic reactions, including anaphylaxis.
U.S. Food and Drug Administration. (2024). Neffy epinephrine nasal spray prescribing information.
United States Patent and Trademark Office. (2020). U.S. Patent No. 10,682,414, intranasal epinephrine formulations.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ars Pharms Operation	NEFFY	epinephrine	SPRAY;NASAL	214697-002	Mar 5, 2025		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				NASAL ADMINISTRATION OF EPINEPHRINE FOR THE TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS	⤷ Start Trial
Ars Pharms Operation	NEFFY	epinephrine	SPRAY;NASAL	214697-001	Aug 9, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				NASAL ADMINISTRATION OF EPINEPHRINE FOR THE TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3678649	⤷ Start Trial	301317	Netherlands	⤷ Start Trial
European Patent Office	3678649	⤷ Start Trial	CA 2025 00007	Denmark	⤷ Start Trial
European Patent Office	3678649	⤷ Start Trial	PA2025507	Lithuania	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,682,414

Which drugs does patent 10,682,414 protect, and when does it expire?

Summary for Patent: 10,682,414