Scope and Claim Construction of US Patent 10,940,110 (Glycopyrrolate Nebulizer Solution): What the Claims Cover, What They Don’t, and How the US Patent Landscape Maps to COPD Inhalation Use

US 10,940,110 is directed to a specific US-style “composition + method of use” estate for a glycopyrrolate aqueous nebulizer solution defined by tight physicochemical parameters (volume, concentration, pH), excipient exclusions (no other bronchodilators; substantially no preservatives; optionally no benzyl alcohol), container form (single-dose ampule), and a delivery context tied to a “high efficiency nebulizer.” The independent claim is claim 1; the dependent claim set narrows toward organic acid inclusion (citric acid), benzyl-alcohol exclusion, and specific concentration and dose-volume embodiments. Claim 10 expands the composition into a COPD treatment method using a high efficiency nebulizer.

What is US Drug Patent 10,940,110 and what do its claims cover (glycopyrrolate composition scope)?

Short answer: The patent claims protect an aqueous glycopyrrolate solution for nebulization having: (i) volume about 0.7 to about 1.0 mL, (ii) concentration about 25 to about 400 μg/mL, (iii) pH about 3 to about 5, (iv) no other bronchodilating agents, (v) substantially free of preservatives, plus optional narrower excipient and container limitations. The protected end use is administering that composition to treat COPD using a high efficiency nebulizer.

Claim 1 (Independent): the core composition boundary

Claim 1 recites:

Dosage-form type: “pharmaceutical composition” that is an aqueous solution of glycopyrrolate
Solution volume: about 0.7 mL to about 1.0 mL
Glycopyrrolate concentration: about 25 μg/mL to about 400 μg/mL
pH: about 3 to about 5
Formulation exclusions:
- free of other bronchodilating agents
- substantially free of preservatives

This claim is not a generic “glycopyrrolate inhalation” patent. It is an IP gate for a specific solution parameter space and excipient constraint package.

Dependent claim 2 and 3: organic acid add-back

Claim 2: composition further comprises an organic acid
Claim 3: organic acid is citric acid (or pharmaceutically acceptable salt)

These claims define a narrower sub-space inside claim 1’s boundary by requiring an organic acid, with citric acid as a further restriction.

Dependent claim 4: benzyl alcohol exclusion

Claim 4: solution is substantially free of benzyl alcohol

This is another excipient-based narrowing. It targets common preservative/solubilization-related formulation choices.

Dependent claims 5, 6: specific numeric embodiments

Claim 5: glycopyrrolate concentration about 25 μg/mL
Claim 6: volume about 1 mL

These create additional fallback positions at low concentration and nominal 1 mL fill.

Claim 7: single-dose ampule container

Claim 7: composition is contained in a single dose ampule

This can matter for infringement because containerization is an element in the claim. A formulation delivered via a different container system (multi-dose vial, cartridge, bag, unit-dose strip) could be outside this dependent limitation.

Claim 8 and 9: an alternate “preferred embodiment” block

Claim 8 repeats core structural language but fixes the volume = about 1.0 mL and concentration = about 25 μg/mL with the same pH 3 to 5 and excipient exclusions.

Claim 9: further comprises citric acid (or salt)

So claims 8-9 are narrower anchors for a specific low-dose/high-volume end.

How is the scope of US 10,940,110 shaped by the “about” ranges and the exclusions (other bronchodilators, preservatives)?

The “about” language creates a claim-flexible but measurable parameter set

The claim uses “about” for:

volume
concentration
pH

From an infringement and design-around standpoint, “about” generally allows minor deviations around the numeric ranges, but the boundaries are still grounded to those ranges. Practically, the protected zone is anchored to:

0.7–1.0 mL
25–400 μg/mL
pH 3–5

A product with pH outside that band or fill volume outside that band is the most direct route to noninfringement of claim 1.

Exclusion “free of other bronchodilating agents” is a category filter

Claim 1 prohibits other bronchodilating agents. That does not mean only “no additional active ingredient,” but it means the formulation must not contain another bronchodilator. That is a meaningful boundary versus:

glycopyrrolate plus a second bronchodilator in the same nebulized solution (for COPD, often LAMA/LABA or LAMA/SABA style combinations)
multi-drug nebulizer cocktails formulated in the same ampule

A separate concomitant bronchodilator administered separately (not “in the pharmaceutical composition”) may fall outside the claim because claim 1 requires the composition to be free of other bronchodilating agents.

“Substantially free of preservatives” is an excipient design constraint

Claim 1 also requires the solution to be substantially free of preservatives. In practical claim-interpretation terms, it is a constraint against:

typical antimicrobial preservatives used in multidose products
preservative systems that are present at non-trivial levels

The dependent claim 4 tightens further with benzyl alcohol.

What does US 10,940,110 protect beyond composition: does it claim methods for COPD treatment?

Yes. Claim 10 is a method claim and incorporates the full composition limitation set.

Claim 10 (Independent method): COPD treatment via high efficiency nebulizer

Claim 10 covers:

Method of treating COPD
Administering to a subject
via a high efficiency nebulizer
using a pharmaceutical composition with the same core formulation constraints as claim 1:
- aqueous glycopyrrolate solution
- volume 0.7–1.0 mL
- concentration 25–400 μg/mL
- pH 3–5
- free of other bronchodilating agents
- substantially free of preservatives

This is important for enforcement against clinical use or product administration setups: if a product uses a different nebulizer efficiency class or device specification, the “high efficiency nebulizer” element can be a legal gating factor.

Dependent method claims 11-18 add the same narrowing features

Claim 11: organic acid included
Claim 12: organic acid is citric acid or salt
Claim 13: substantially free of benzyl alcohol
Claim 14: glycopyrrolate concentration about 25 μg/mL
Claim 15: volume about 1 mL
Claim 16: composition in single dose ampule
Claim 17: repeats the fixed-volume/fixed-concentration version (1.0 mL, 25 μg/mL; pH 3–5; free of other bronchodilators; substantially free of preservatives)
Claim 18: citric acid (or salt) add-on for that fixed embodiment

What specific dependent limitations create the strongest infringement handles (single-dose ampule, citric acid, benzyl alcohol, concentration/volume)?

From a claim-to-practice mapping perspective, the most enforceable “handles” are the limitations that are likely to be documented in development dossiers, labeling, and manufacturing specifications:

High efficiency nebulizer (method claim limitation)
Single dose ampule (container limitation in claim 7 and claim 16)
No other bronchodilating agents (combination avoidance)
Substantially free of preservatives and substantially free of benzyl alcohol
Quantified volume, concentration, pH (composition measurement)

Narrowest “numeric anchor points” for fallback positions

The dependent numeric claims can be used as fallback narrowing positions even if broader ranges are disputed:

about 25 μg/mL (claim 5 and claim 14)
about 1 mL (claim 6 and claim 15)
fixed embodiment block in claims 8 and 17:
- volume about 1.0 mL
- concentration about 25 μg/mL
- pH 3 to 5
- no other bronchodilators
- substantially free of preservatives

Organic acid and citric acid carve-in

If a commercially used formulation uses citric acid (common for pH adjustment and buffering), claims 2-3 and 11-12 and the narrower citric-acid dependent claims on the fixed numeric embodiment (claims 9 and 18) become highly relevant.

How does the claim set compare to typical glycopyrrolate COPD nebulizer product designs (where claims align and where they don’t)?

Likely alignment areas (highest infringement risk)

A single-ingredient aqueous glycopyrrolate nebulizer solution with no second bronchodilator
Preservative-free or near preservative-free single-dose ampules
A buffered pH within 3 to 5
Use of citric acid as an organic acid component (optional but common)
Low-ended dosing corresponding to around 25 μg/mL in a ~1.0 mL fill

Likely nonalignment areas (most direct design-around)

Formulations with pH outside 3–5
Fill volumes outside 0.7–1.0 mL
Concentrations outside 25–400 μg/mL
Combination nebulized products that include another bronchodilator in the same ampule/composition
Preservative systems that are not “substantially free” (depending on interpretive thresholds)
Benzyl-alcohol containing formulations (implicated by claim 4/13)
Administration contexts that do not use a high efficiency nebulizer for claim 10/11 et al. (depends on device classification and claimed definition)

What does the patent landscape likely look like around US 10,940,110 (related claim themes to map the family/competitors)?

The information provided contains only the claim text and not the bibliographic data (filing date, assignee, family, priority, prosecution history), so a complete, citation-backed landscape cannot be produced. Under business review standards, a “landscape” requires at least assignee/priority and Orange Book device/drug mapping, or it becomes non-actionable.

What can be asserted from the claim structure is the landscape adjacency that matters for freedom-to-operate:

Formulation patents: aqueous glycopyrrolate solution parameters, pH/buffer systems (including citric acid), preservative levels, and benzyl alcohol exclusion
Device-administration claims: “high efficiency nebulizer” method constraints
Combination avoidance patents: compositions that include only glycopyrrolate versus LAMA/LABA combos or multi-active nebulizer systems
Container/form factor patents: single-dose ampule vs multi-dose vial designs

A competitor seeking to launch without risking claim 1/10 typically targets at least one hard element: pH, volume, concentration, preservative presence, benzyl alcohol presence, or inclusion of another bronchodilator in the same composition, plus potentially the nebulizer efficiency context for method claims.

Claim-by-claim infringement matrix for formulation and use scenarios

Scenario (example design choice)	Claim 1 risk	Claim 7 / 16 risk	Claim 2-3 / 11-12 risk	Claim 4 / 13 risk	Claim 10 risk (device-dependent)
Glycopyrrolate single-ingredient aqueous neb solution; pH 4.0; 1.0 mL fill; ~25-400 μg/mL; preservative-free	High	High (if single-dose ampule)	Medium (if citric acid used)	Medium-Low (if benzyl alcohol absent)	High (if “high efficiency nebulizer”)
Same but pH 2.8 or pH 5.3	Low	Low (container dependent)	Low	Low	Low (because composition incorporated)
Same but fill volume 0.6 mL or 1.2 mL	Low	Low	Low	Low	Low
Glycopyrrolate + second bronchodilator in same ampule	Low (violates “free of other bronchodilating agents”)	Low	Low	Low	Low
Preservatives included beyond “substantially free” threshold	Low-Med (depends on “substantially”)	Med	Med	Med	Low-Med
Benzyl alcohol present above “substantially free”	Med (depends)	Med	Med	High	Med
Same composition but administered with a nebulizer not meeting “high efficiency” characterization	High (composition claims)	High	High	High	Reduced if “high efficiency nebulizer” cannot be met

Key Takeaways

US 10,940,110 is a targeted IP package for a specific aqueous glycopyrrolate nebulizer solution with measurable constraints: 0.7–1.0 mL, 25–400 μg/mL, pH 3–5.
The claims also impose exclusions: the solution is free of other bronchodilating agents and substantially free of preservatives, with an additional narrower limitation excluding benzyl alcohol.
Dependent claims narrow into practical formulation attributes: single-dose ampules, citric acid (or salts), and fixed low-dose (about 25 μg/mL) embodiments at about 1.0 mL fill.
Claim 10 extends protection into a COPD method of treatment when administered via a high efficiency nebulizer, adding a device-context element distinct from the composition-only claims.
Design-around efforts that keep glycopyrrolate but change pH, fill volume, concentration, excipient strategy (preservatives/benzyl alcohol), inclusion of other bronchodilators, or nebulizer efficiency context are the most direct routes to reduce infringement risk.

FAQs

1) Does US 10,940,110 require a preservative-free formulation, or just “substantially free of preservatives”?
It requires the aqueous glycopyrrolate solution to be substantially free of preservatives (claim 1), with a separate dependent limitation for substantially free of benzyl alcohol (claim 4).

2) Are combination COPD nebulizer solutions covered if they include another bronchodilator with glycopyrrolate in the same ampule?
Claim 1 requires the solution to be free of other bronchodilating agents, so inclusion of another bronchodilator in the same pharmaceutical composition conflicts with that limitation.

3) What formulation parameter most directly determines claim 1 infringement exposure: pH, volume, or concentration?
All three are required: pH (3–5), volume (0.7–1.0 mL), and concentration (25–400 μg/mL). A change to any one outside its range can remove claim 1 protection.

4) Do the method claims depend on the container (single-dose ampule) as well as the nebulizer type?
Only the specific dependent method claims do. Claim 10 itself does not require a single-dose ampule. Claims 16 and 7 add single-dose ampule as a further limitation.

5) If a product uses citric acid for pH adjustment, does that automatically bring it into the narrower dependent claims?
If citric acid (or its pharmaceutically acceptable salt) is present, it can satisfy the additional limitation in claims 2-3 (composition) and 11-12 (method). It does not eliminate the need to satisfy the base constraints of claim 1 or claim 10.

References

No external sources were cited because the prompt provided only claim language for US 10,940,110 and did not include bibliographic identifiers or any court/FDA/Orange Book data needed to support landscape assertions with citations.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	10,940,110	⤷ Start Trial	Y			LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)	⤷ 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
Australia	2009241628	⤷ Start Trial
Canada	2716936	⤷ Start Trial
European Patent Office	2257172	⤷ Start Trial
European Patent Office	3311820	⤷ Start Trial
United Kingdom	201008994	⤷ Start Trial
United Kingdom	2468073	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,940,110

Which drugs does patent 10,940,110 protect, and when does it expire?

Summary for Patent: 10,940,110