US Patent 10,413,505: Scope, Claims, and US Patent Landscape for Cocaine Hydrochloride Pledget Induction in Adult Nasal Procedures

What is the core claim scope of US Patent 10,413,505?

US Drug Patent 10,413,505 is directed to a method for inducing local anesthesia of mucous membranes in adult patients using intranasal cottonoid pledgets soaked in a small-volume cocaine hydrochloride solution. The method ties together (i) unit dose construction (how many pledgets, how much drug each absorbs), (ii) administration (where and how long pledgets contact the septum), (iii) exposure targets (Cmax and/or AUCinf ranges), and (iv) a functional clinical endpoint (pain reduction equivalent to von Frey filament testing visual numeric rating score = 0) following a defined nasal procedure.

The claims are structured so that the exposure metrics (Cmax or AUCinf) operate as conditions of success for the claimed method, not as merely descriptive pharmacokinetics.

Independent claim architecture

There are two independent claims with substantively similar administration and clinical endpoint language:

Component	Claim 1	Claim 8
Drug form	Cocaine hydrochloride, “naturally derived,” 36 mg/mL to 44 mg/mL	Same
Bottle volume	About 4 mL total containing drug solution	Same
Pledgets	Four cottonoid pledgets	Same
Dose loading	Soak until each pledget absorbs about 40 mg cocaine hydrochloride	Same
Intranasal placement	Two pledgets in each nasal cavity, contacting septum	Same
Contact time	About 10 to 20 minutes	Same
Exposure condition	Cmax range: 19.7 to 54.3 ng/mL	AUCinf range: *30.8 to 79.0 ngh/mL**
Post-contact procedure	Procedure selected from: nasal laryngoscopy, nasopharyngeal laryngoscopy, nasal debridement	Same
Pain endpoint	Pain reduction equivalent to von Frey visual numeric rating score 0	Same

Dependent claims

Claims 2-4 and 12-14 narrow the selected procedure type; claims 5-6 and 9-10 narrow pledget dimensions; claims 7 and 11-16 specify target exposure values or subranges.

Claim set	Limitation
Claims 2-4	Procedure = nasal laryngoscopy / nasopharyngeal laryngoscopy / nasal debridement
Claims 5-6	Pledget length 3.0 cm to 8.0 cm; and/or length about 4 cm with height about 1.3 cm
Claim 7	Cmax about 37 ng/mL
Claims 12-14	Same procedure-specific narrowing for claim 8
Claims 9-10	Same pledget dimension narrowing for claim 8
Claims 11	*AUCinf about 54.9 ngh/mL**
Claims 15-16	AUCinf subranges: 30.8 to 54.9; and 54.9 to 79.0 ng*h/mL

What exact method steps and parameters define infringement-relevant practice?

The claim scope is not directed to “cocaine anesthesia” generally. It is directed to an exact administration method with numerical dosing, exposure, time, and outcome.

1) Composition and dose-loading

Solution concentration: about 36 mg/mL to about 44 mg/mL naturally derived cocaine hydrochloride
Total solution volume in one bottle: about 4 mL
Number of pledgets: four cottonoid pledgets
Soaking endpoint: “until each pledget absorbs about 40 mg” cocaine hydrochloride

From a scope standpoint, the claim is sensitive to:

the concentration window (36 to 44 mg/mL),
the per-pledget absorbed amount (about 40 mg),
and the implied total dose delivered through four pledgets (approximately 160 mg total absorbed across four pledgets, assuming “about” tolerates small variability).

2) Intranasal application geometry and duration

Administration location: contact two pledgets in each nasal cavity against a septum
Contact time: 10 to 20 minutes

This defines both:

the number of pledgets used per side (two per nasal cavity),
the anatomic contact target (septum),
and a timing window likely relevant to absorption and local effect.

3) Exposure gating via Cmax and AUCinf

The claims explicitly require that the method “results in” pharmacokinetic exposure within narrow ranges:

For claim 1 (Cmax condition):

Cmax: 19.7 to 54.3 ng/mL cocaine

For claim 8 (AUCinf condition):

AUCinf: *30.8 to 79.0 ngh/mL** cocaine

Why this matters legally in practice: these are not merely measurements after the fact; they are claim conditions. Any design-around likely targets a shift outside these windows (through concentration, dosing uniformity, contact time, pledget geometry, drug derivation, or administration technique).

4) Procedure and clinical outcome linkage

The method includes a required post-contact procedure selected from:

nasal laryngoscopy
nasopharyngeal laryngoscopy
nasal debridement

And it requires a functional outcome:

“reduction in pain equivalent to achieving a visual numeric rating score of 0 upon von Frey filament testing.”

This outcome language constrains the claim to methods that deliver analgesia sufficient to meet a specific test result.

Where does the claim get narrower? (Procedure, pledget dimensions, and fixed PK values)

Procedure narrowing (dependent claims)

Dependent claims explicitly tie the same anesthesia method to a specific downstream procedure:

Claim 2 / 12: nasal laryngoscopy
Claim 3 / 13: nasopharyngeal laryngoscopy
Claim 4 / 14: nasal debridement

These do not materially change upstream dosing/exposure requirements; they narrow the post-contact clinical use case.

Pledget size narrowing

Two dependent constraints exist:

Claim 5 / 9: length of each pledget from 3.0 cm to 8.0 cm
Claim 6 / 10: height about 1.3 cm and length about 4 cm

These likely matter because pledget size can affect:

absorption kinetics,
surface area contact,
and delivered drug release into nasal mucosa.

Fixed PK point estimates

The claims also lock in specific exposure values:

Claim 7: Cmax about 37 ng/mL
Claim 11: *AUCinf about 54.9 ngh/mL**
Claim 15-16: AUCinf split ranges around 54.9 ng*h/mL

These create an additional infringement funnel: methods that hit the “about” fixed targets fall within more specific dependent claim coverage.

What is the likely “essential” claim core versus “optional” perimeter?

A practical map of claim elements:

Essential core elements likely to drive literal coverage

Four cottonoid pledgets soaked in one 4 mL bottle of cocaine hydrochloride solution at 36-44 mg/mL
Each pledget absorbs about 40 mg
Two pledgets per nasal cavity contacting the septum
Contact time 10-20 minutes
The method produces exposure within:
- claim 1: Cmax 19.7-54.3 ng/mL
- claim 8: *AUCinf 30.8-79.0 ngh/mL**
Afterward, perform a listed nasal procedure
Pain outcome: von Frey visual numeric rating score of 0

Perimeter elements that refine coverage

Pledget length/height limitations (claims 5-6, 9-10)
Specific exposure point values (claims 7, 11)
Specific subranges (claims 15-16)
Specific procedure selection by dependent claims (claims 2-4, 12-14)

How would competitors design around this claim set? (Non-infringing directionality based on scope)

Claim drafting suggests infringement is tied to meeting all numerical windows simultaneously with the clinical endpoint. Design-around strategies, based on scope triggers in the claims, include shifting at least one required element outside claim language:

Most direct levers (based on explicit numerical limitations)

Dose concentration window: move outside 36-44 mg/mL
Absorbed per pledget: move outside “about 40 mg” per pledget
Contact time: move outside 10-20 minutes
PK exposure targets: generate Cmax or AUCinf outside the claimed windows
Number/placement geometry: avoid “two pledgets in each nasal cavity against a septum” configuration
Clinical outcome proof: avoid achieving a von Frey numeric rating of 0 under the test framework (use alternative anesthesia strategy)

Secondary levers

Pledget dimensions: change length/height so dependent limitations are avoided (though independent claims may still cover if those dimensions are not required in the independent claim text)

What is the US patent landscape around this specific method class?

Based strictly on the claim text you provided, the landscape can be categorized into four practical clusters that typically interact with this kind of method-of-use and localized delivery approach:

Cocaine hydrochloride formulations and local anesthetic delivery systems
- Patents covering intranasal/local use of cocaine salts
- Patents covering dosing forms that resemble cottonoid/pledget delivery
Method-of-treatment claims for nasal endoscopy or debridement analgesia
- Use patents tied to nasal laryngoscopy, nasopharyngeal laryngoscopy, and debridement endpoints
- Clinical protocols including timing and topical delivery steps
Pharmacokinetic targeting and systemic exposure constraints
- Less common but present where claims tie local/topical dosing to systemic Cmax/AUC thresholds
Device-anchored or procedural claims using pledgets
- Patents covering pledget dimensions, soak times, absorbable carriers, and placement mechanics

Landscape implications for freedom-to-operate

If a competitor uses cocaine hydrochloride intranasally with a pledget soaking method, they are likely to face overlap risks across multiple patent strata: formulation + method of delivery + procedure use + outcome and PK targets.
The presence of Cmax/AUCinf gating suggests this patent is designed to distinguish prior art on systemic exposure profiles, not only on local anesthetic effect.

What does the claims’ structure signal about novelty and claim strength?

The inclusion of both:

a mechanistic delivery definition (soak pledgets, absorbed dose, placement, time), and
pharmacokinetic success criteria (Cmax/AUCinf ranges),
tied to a specific pain test outcome (von Frey score 0),

suggests the patent sought to secure novelty around a performable method that demonstrates both effectiveness and a systemic exposure profile. This often increases enforceability because it narrows infringement to methods that can replicate the same PK and outcome.

Key Takeaways

US 10,413,505 claims a specific intranasal cocaine hydrochloride pledget method: four cottonoid pledgets soaked in a 4 mL, 36-44 mg/mL cocaine hydrochloride solution until each absorbs ~40 mg; two pledgets per nostril contacting the septum for 10-20 minutes.
The method is constrained by pharmacokinetic success criteria: Cmax 19.7-54.3 ng/mL (claim 1) or *AUCinf 30.8-79.0 ngh/mL** (claim 8).
The method also requires a post-contact nasal procedure (nasal laryngoscopy, nasopharyngeal laryngoscopy, or nasal debridement) and a von Frey testing endpoint: pain reduction equivalent to visual numeric rating score 0.
Dependent claims refine scope by procedure selection, pledget dimensions, and specific PK targets (Cmax ~37 ng/mL; AUCinf ~54.9 ng*h/mL; and subranges).
Competitive design-around is most plausibly achieved by moving at least one required numeric parameter (concentration, absorbed dose per pledget, contact time, placement geometry, or PK exposure range) so the method no longer “results in” the claimed Cmax or AUCinf windows while also not meeting the von Frey score endpoint.

FAQs

1) Does US 10,413,505 claim a cocaine composition alone?
No. It claims a method that combines cocaine hydrochloride dosing via soaked pledgets, an application protocol, PK exposure ranges, and a von Frey pain endpoint after a specified nasal procedure.

2) Are Cmax and AUCinf both required in the same claim?
No. Claim 1 uses a Cmax range; claim 8 uses an AUCinf range.

3) Is the pain endpoint required even if the procedure is performed?
Yes. The method requires pain reduction equivalent to a von Frey visual numeric rating score of 0.

4) Can different procedures fall under the independent claims?
Yes. Both independent claims cover the procedure selected from the same group: nasal laryngoscopy, nasopharyngeal laryngoscopy, or nasal debridement.

5) What elements most likely determine infringement risk?
The soaked pledget dosing construction (concentration, bottle volume, number of pledgets, absorbed mass per pledget), the contact time and septum placement, and meeting the PK window (Cmax or AUCinf) while achieving the von Frey endpoint.

References

[1] US Patent 10,413,505. Claims 1-16 (as provided in user prompt).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lxo Ireland	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES	⤷ Start Trial
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES	⤷ 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

Details for Patent: 10,413,505

Which drugs does patent 10,413,505 protect, and when does it expire?

Summary for Patent: 10,413,505