Details for Patent: 11,918,655

Which drugs does patent 11,918,655 protect, and when does it expire?

Patent 11,918,655 protects NEFFY and is included in one NDA.

This patent has eighty-four patent family members in thirty-three countries.

Summary for Patent: 11,918,655

Title:	Intranasal epinephrine formulations and methods for the treatment of disease
Abstract:	Drug products adapted for nasal delivery comprising formulations with epinephrine and devices comprising such formulations are provided. Methods of treating anaphylaxis with epinephrine products are also provided.
Inventor(s):	Richard Lowenthal, Edward T. Maggio, Robert G. Bell, Pratik Shah
Assignee:	Aegis Therapeutics LLC
Application Number:	US18/206,881
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,918,655
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Device;

Executive summary: U.S. Patent 11,918,655 is a method-and-formulation estate centered on intranasal epinephrine delivered as a nasal spray for type-1 hypersensitivity (with heavy claim weight on anaphylaxis) using (i) epinephrine as the only active moiety (single-API constraint), (ii) tight concentration and dose-volume windows (notably ~0.5–20 mg/mL with ~25–250 µL/dose, including multiple dependent “spot” doses), (iii) acidic pH 3.0–5.0, and (iv) specific absorption enhancement / excipient packages (notably dodecyl maltoside plus benzalkonium chloride and EDTA/disodium EDTA). The claim architecture is broad at the method level but narrows progressively to practical, device- and PK-defined embodiments (including Tmax <45 minutes and single actuation into one nostril). This structure creates a layered infringement landscape: generics and entrants can design around by changing (a) nasal delivery route (non-nasal or combined routes), (b) active-ingredient purity (adding a second API), (c) excipient selection (swap absorption enhancers or eliminate benzalkonium chloride), (d) pH (move outside 3.0–5.0), or (e) dose presentation (avoid the claimed concentration-volume and device/actuation features).

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U.S. Patent 11,918,655 landscape: What patents protect intranasal epinephrine nasal spray for anaphylaxis and other type-1 hypersensitivity?

What is the core claim theme in US 11,918,655?

Claim 1 is the independent anchor and frames the estate around five infringement hooks:

1. Route: intranasal administration via nasal spray.
2. Active-ingredient constraint: epinephrine (or a salt) is the only pharmaceutically active ingredient.
3. Dose geometry:
   • Concentration: ~1–40 mg/mL (epinephrine or salt)
   • Per-dose volume: ~25–250 µL
4. Indications and symptom framing: type-1 hypersensitivity includes allergy asthma, allergic conjunctivitis, allergic rhinitis, anaphylaxis, angioedema, urticaria, eosinophilia, and combinations.
5. PK/clinical functional result: plasma epinephrine concentrations are “efficacious” for either
   • elimination of one or more symptoms, or
   • prevention of further progression of symptoms.

The dependent claims then lock down concentrations, salts, excipient packages, and anaphylaxis-specific symptom lists.

How are claim scope boundaries drawn (what is included vs. excluded)?

Included by claim language:

• Epinephrine free base or salts, with an explicit salt list in dependent claim 9.
• Wide concentration range in method claim 1 (1–40 mg/mL) but narrower “spot” ranges elsewhere (notably 10 and 20 mg/mL).
• Volume range and many discrete volumes (50, 75, 100, 125, 150, 175, 200, 250 µL).
• Acidic formulation pH 3.0 to 5.0 (dependent claim 7 and multiple later claim families).
• Specific excipient categories:
  • absorption enhancement agents (broad genus, then narrower options)
  • isotonicity agents (broad genus, then narrower options)
  • stabilizers (EDTA/disodium EDTA)
  • preservatives (benzalkonium chloride)
  • antioxidants (including optional sodium metabisulfite)
  • pH adjustment agents

Excluded by claim language:

• Any formulation where epinephrine is not the only pharmaceutically active ingredient (claims 1/21/31).
• Nasal administration variants that do not meet the stated dose concentration and volume windows (claims 1, 21, 31, 34, 36, etc.).
• Formulations outside pH 3.0–5.0 when relying on dependent “excipient/pH packages” for scope.
• Embodiments that do not meet device/actuation and Tmax <45 minutes features (claims 34/36/37/41).

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What claims in US 11,918,655 are broad enough to catch next-gen products?

Which independent claims are the infringement “broad gates”?

US 11,918,655 effectively uses three broad independent-type claim themes (even if only Claim 1 and later are shown in the prompt):

1. Broad method claim for type-1 hypersensitivity (Claim 1)
   • Intranasal, nasal spray, epinephrine-only active, 1–40 mg/mL, 25–250 µL/dose.
2. Broad method claim with narrower framing of epinephrine as only active moiety (Claim 21)
   • Similar but presented as “only active moiety,” with concentration 1–40 mg/mL and 25–250 µL.
3. Broad anaphylaxis method claims anchored on single-dose and aqueous formulation (Claims 31–34 family)
   • Epinephrine-only active, ~1–2 mg in 50–250 µL, single nasal spray actuation features appear in later claim steps.
4. Formulation composition claim (Claim 44)
   • Fixed composition: 2.0 mg/100 µL epinephrine plus a specified excipient set and pH adjusters.

What makes Claim 1 hard to design around?

Claim 1 is broad on:

• Indication basket (multiple type-1 hypersensitivity manifestations).
• Concentration range (1–40 mg/mL).
• Volume range (25–250 µL).
• Salt versatility (salts included).
• “Efficacious” functional language for symptom elimination or progression prevention.

The most practical design-around levers against Claim 1 are not the concentration and volume per se, but:

• break the “only active” constraint by adding a second active drug entity, or
• move pH/excipient package outside dependent claim limitations if the target suit relies on dependent excipient claims,
• or avoid the claimed PK target only if “efficacious for plasma concentrations” is litigated with testable thresholds (the prompt does not supply explicit numeric plasma concentration cutoffs, only “efficacious”).

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How do the dependent claims narrow dosage strength, volume, and epinephrine salts?

Which concentration and volume embodiments are explicitly claimed?

The claim set contains multiple “ladder” dependencies and spot embodiments:

Concentration ladder under Claim 1

Claim 3 lists epinephrine (salt) concentrations:

• ~3, 4, 5, 6, 7, 8, 9, 10, 11, …, 20 mg/mL.

Claim 4 adds a specific dependent range emphasis:

• 10–20 mg/mL in increments.

Claim 5-6 focus on:

• ~10 mg/mL in 50–200 µL
• ~20 mg/mL in 50–200 µL

Claim 10-13 embed fixed excipient sets with 10 mg/mL and/or 20 mg/mL at specific volume points:

• 10 mg/mL at 50–200 µL (Claim 10)
• 20 mg/mL at 50–250 µL with multiple volume options (Claim 11)
• 10 mg/mL at 100 µL (Claim 12)
• 20 mg/mL at 100 µL (Claim 13)

Discrete volume points repeatedly used

The prompt lists discrete volumes: 50, 75, 100, 125, 150, 175, 200, 250 µL in multiple dependent claims (Claims 10–13 and 17–20 and 11/12/13).

What salt forms are enumerated?

Claim 9 limits epinephrine salts to:

• epinephrine acetate
• epinephrine hydrochloride
• epinephrine tartrate
• epinephrine bitartrate
• epinephrine hydrogen tartrate
• epinephrine borate

This list matters for infringement of dependent claims that specify “salt thereof,” though Claim 1 already broadly includes “epinephrine or a salt thereof.”

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What formulations and excipient packages are protected by US 11,918,655?

Which excipient categories are claimed broadly (and which are locked)?

Broad excipient genus (Claim 7 and Claim 24)

Dependent claim 7 includes excipients categories and pH 3.0–5.0:

• absorption enhancement agents
• isotonicity agents
• stabilizing agents
• antioxidants
• preservatives
• pH adjustment agents
• water

Claim 24 repeats the excipient categories framing for the Claim 21 family.

Specific exemplar excipient menu in Claim 8

Claim 8 expands into explicit examples:

Absorption enhancement agents (examples):

• alkyl glycosides
• fatty acids
• bile salts
• cyclodextrins
• phospholipids
• alcohols

Isotonicity agents (examples):

• dextrose
• glycerin
• mannitol
• potassium chloride
• sodium chloride

Stabilizing agent:

• EDTA or disodium EDTA

Antioxidants (examples):

• alpha tocopherol
• D-α-tocopherol polyethylene glycol 1000 succinate
• ascorbic acid
• isoascorbic acid
• BHA
• citric acid monohydrate
• potassium metabisulfite
• sodium bisulfite
• sodium metabisulfite
• sodium sulfite

Preservative:

• benzalkonium chloride

pH adjustment agents:

• adipic acid, ammonium chloride, citric acid
• acetic acid, hydrochloric acid
• lactic acid, phosphoric acid
• propionic acid, sulfuric acid
• tartaric acid
• sodium hydroxide, sodium citrate
• sodium bicarbonate, sodium carbonate

Tighter composition in Claim 14 and Claim 10-13

Claim 14 locks a specific excipient selection:

• absorption enhancement agent: dodecyl maltoside
• isotonicity agent: sodium chloride
• stabilizer: EDTA/disodium EDTA
• preservative: benzalkonium chloride
• optional antioxidant: sodium metabisulfite
• pH adjusted with HCl and/or NaOH
• water
• pH 3.0–5.0

Claims 10–13 also use a fixed excipient set with dodecyl maltoside, sodium chloride, sodium metabisulfite, EDTA/disodium EDTA, and benzalkonium chloride, and pH adjustment with HCl/NaOH to pH 3.0–5.0.

Which absorption enhancers are explicitly enumerated later (design-around target)?

Claim 40 lists specific absorption enhancer alternatives:

• dodecyl maltoside
• polysorbate 20
• polysorbate 80
• oleic acid
• sodium lauryl sulfate
• sodium glycocholate
• sodium taurocholate
• sodium taurodihydrofusidate

Claim 39 lists the broader genus again (alkyl glycosides, fatty acids, bile salts, cyclodextrins, phospholipids, alcohols).

Practical implication: a competitor can attempt to design around by choosing an absorption enhancer not in these sets, but the presence of earlier broad genus language (Claim 7/8) can still capture variants if “selected from the group” is treated broadly in claim interpretation. The safest carve-outs are those that avoid the claim’s explicitly enumerated or functionally equivalent excipient sets, and also avoid the specific excipient combinations paired with pH.

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When does US 11,918,655 lose exclusivity? What is the expiration timeline?

What expiration date applies to US 11,918,655?

No filing date, priority date, or terminal disclaimer details were provided in the prompt, so a complete and accurate expiration timeline cannot be produced from the supplied information.

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What anaphylaxis-specific limitations increase enforcement leverage?

What “anaphylaxis” claim family elements are most actionable?

The anaphylaxis-heavy claims add operational constraints:

Single-dose with fixed strength range

• Claim 31: 1.0–2.0 mg epinephrine in 50–250 µL, epinephrine-only active, intranasal.
• Claim 33: 2.0 mg epinephrine in 100 µL, one actuation, one nostril.
• Claim 34: same as claim 33 with PK feature: Tmax <45 minutes.

Tmax constraint is a key narrowing feature

• Claim 35: tightens to Tmax <35 minutes.
• Claim 36–38 and Claim 37–38 repeat the “Tmax <45 minutes” and “Tmax <35 minutes” constraints.

Emergency-use definition + specific excipient set

• Claim 41: emergency treatment with a fixed excipient set (dodecyl maltoside + benzalkonium chloride + sodium chloride + disodium EDTA + sodium metabisulfite + pH adjusters), with one actuation into one nostril and Tmax <45 minutes.

These features can be powerful in litigation if plaintiffs can show measured Tmax under relevant study designs.

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What generic entry risks exist for intranasal epinephrine nasal spray?

Which design-around strategies are most aligned to the claim language?

Given the claim structure, the largest risk points for entrants are:

1. Route and device: intranasal nasal spray, and for some claims, one-actuation into one nostril.
2. Single active constraint: epinephrine-only.
3. Dose geometry: concentration/volume inside the claimed windows.
4. pH range: 3.0–5.0.
5. Excipients: dodecyl maltoside, benzalkonium chloride, EDTA/disodium EDTA, sodium chloride and optional sodium metabisulfite, plus device/PK features.

High-confidence design-around levers (based strictly on the supplied claims):

• Use an alternative active moiety (break “only active ingredient/moiety”).
• Change pH outside 3.0–5.0 while keeping efficacy.
• Eliminate the claimed preservative (benzalkonium chloride) or change the excipient package such that it no longer matches dependent claims that specify exact sets.
• Use different dose strengths and volumes that fall outside the enumerated windows for the strongest dependent claims (10/20 mg/mL at 50–250 µL, and 1–2 mg in 50–250 µL, and the 2.0 mg/100 µL one-nostril embodiments).
• Avoid the device/actuation and Tmax constraints where they are required for infringement of those narrower claims.

Where do “broad independent” claims still catch variants?

Even if an entrant avoids dependent formulation embodiments (like the fixed dodecyl maltoside + benzalkonium chloride set), Claim 1 and Claim 21 can still be asserted if the entrant still practices:

• intranasal epinephrine-only nasal spray,
• dose concentration and volume within 1–40 mg/mL and 25–250 µL,
• and generates “efficacious” plasma concentrations to eliminate/prevent symptoms.

So the safest carve-outs are structural: active-ingredient purity, route, dose geometry, or PK outcome evidence.

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How strong is the patent estate for US 11,918,655?

Strength factors visible from claim drafting

• Multiplicity of dependent claim “funnels”: concentration ladders, volume points, excipient package sets, and discrete anaphylaxis dosing/device/PK features.
• Functional PK language (“efficacious plasma concentrations”) plus a measurable PK feature (Tmax) in multiple dependent claims.
• Composition claim at the end (Claim 44) that fixes a specific formulation with a specific set of excipients and pH adjusters.

Weakness factors visible from the supplied text

• Several key elements use “efficacious” rather than numeric plasma thresholds in the broad independent claim text shown, which can complicate enforcement if the claim is litigated as requiring proof of efficacy at a measurable numeric plasma level.
• The claim scope is tied to intranasal delivery and specific concentration/volume ranges, so well-executed out-of-range products may avoid infringement.

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What patent litigation or Orange Book status applies?

No Orange Book listing, FDA product mapping, litigation docket details, or APA/Paragraph IV history were provided in the prompt, so this analysis cannot be completed from the supplied information.

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Key Takeaways

• US 11,918,655 protects intranasal epinephrine nasal spray for type-1 hypersensitivity, with a major enforcement focus on anaphylaxis.
• The broadest claims require: route (intranasal nasal spray), epinephrine as the only active moiety, and dose geometry (1–40 mg/mL and 25–250 µL).
• Dependent claims tightly expand the infringement surface through: specific concentrations (including 10 mg/mL and 20 mg/mL), discrete volumes (50–250 µL), salt enumeration, and acidic pH 3.0–5.0.
• The excipient “signature” strengthens enforcement: dodecyl maltoside (absorption enhancer), benzalkonium chloride (preservative), EDTA/disodium EDTA (stabilizer), sodium chloride (isotonicity), and sodium metabisulfite (optional antioxidant in some embodiments).
• Narrower anaphylaxis claims add single-actuation into one nostril and Tmax <45 minutes (and <35 minutes), creating measurable PK-based enforcement leverage.
• The strongest design-arounds are structural: change active moiety set, move outside pH or excipient packages, and avoid the claimed concentration-volume and device/PK embodiments.

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FAQs

1. Can a formulation with epinephrine plus another active ingredient infringe Claim 1?
   No, the claim language requires epinephrine to be the only pharmaceutically active ingredient/moiety.

2. Do the claims cover epinephrine salts even if the formulation uses epinephrine free base?
   The broad independent claims include epinephrine “or a salt thereof”; the dependent salt-specific claim lists specific salts.

3. Are the strongest barriers to entry the excipients or the dosing parameters?
   Both matter, but dosing geometry (concentration and volume windows) and the “only active” constraint are structural and harder to offset.

4. Do the anaphylaxis claims require one-nostril dosing and fast Tmax?
   The narrower anaphylaxis dependent claims (e.g., with Tmax) add those operational/PK constraints.

5. Does the composition claim (Claim 44) matter for method-based infringement strategy?
   Yes. A dedicated formulation claim broadens infringement to product composition and can support enforcement even where method claims are more difficult.

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References (APA)

1. United States Patent 11,918,655. (Patent claims provided in prompt text).

Drugs Protected by US Patent 11,918,655

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						NASAL ADMINISTRATION OF EPINEPHRINE FOR THE TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS
Ars Pharms Operation	NEFFY	epinephrine	SPRAY;NASAL	214697-001	Aug 9, 2024		RX	Yes	Yes			Y			NASAL ADMINISTRATION OF EPINEPHRINE FOR THE TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS

International Family Members for US Patent 11,918,655

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