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Patent landscape, scope, and claims: |
Patent 11,197,822: Scope, claim-by-claim coverage, and US patent landscape for oral budesonide and fluticasone in palatable, viscous unit-dose dosage forms
The US drug patent 11,197,822 covers oral unit-dose formulations of budesonide or fluticasone that are palatable and viscosity-increasing, with specified excipient ranges and dosage-form types (aqueous suspension, semi-solid, or mouth-dissolving solid). The independent claim is broad on corticosteroid identity (budesonide/fluticasone), dosage-form category, and viscosity mechanism (any excipient increasing viscosity to meet the defined range). It is narrower in practice because viscosity and excipient selection are structurally tied to defined recitations, and because the claims anchor to palatability and “nectar-like to honey-like” sensory viscosity, plus unit-dose volume and dosing cadence.
What is US Drug Patent 11,197,822 and what does it claim in plain terms?
US Patent No. 11,197,822 claims an oral dosage form for systemic-adjacent anti-inflammatory effect using topically active corticosteroids (specified as budesonide or fluticasone), formulated to be accepted by oral administration through taste/palatability excipients and viscosity modifiers, delivered as unit doses.
Core elements appearing across independent claim 1 (and claim set 13)
- Active: topically active corticosteroid selected from budesonide and fluticasone.
- Palatability: a first excipient that improves palatability.
- Viscosity: a second excipient increasing viscosity, recited by either:
- a w/v concentration range (claim 1), or
- a rheological minimum (claim 13, “at least about 25 cP” at specified conditions).
- Oral unit-dose form:
- aqueous suspension, semi-solid, and/or solid that dissolves in the mouth (claim 1).
- claim 13 specifies aqueous suspension.
- Unit-dose volume: ~5 mL to ~15 mL (claim 10, and in claim 13).
- Dose amount: ~0.01 mg to ~10 mg (claim 7) and sub-ranges (claims 8, 16-17, 22-23).
- Dosing frequency: suitable for once a day and no more than once a day (claims 5-6).
- Sensory viscosity characterization: “nectar-like to honey-like” (claim 9, claim 15).
- Solid form examples: dissolving tablet/wafer (claim 4).
- Viscosity excipient exemplars: maltodextrin, carboxymethyl cellulose, microcrystalline cellulose, or combinations (claims 2 and 14).
What is the scope of claim 1: oral palatable viscous unit-dose budesonide/fluticasone?
Claim 1 is the foundational independent claim. It is drafted as a composition claim with multiple nested limitations. In infringement analysis, all recited features must be met.
Claim 1 breakdown (scope drivers vs. limiting features)
A. Active ingredient scope
- “Topically active corticosteroid” is restricted to budesonide and/or fluticasone.
- This excludes other steroids (e.g., triamcinolone, mometasone).
B. Dosage form categories
- “Oral dosage form” includes:
- aqueous suspension,
- semi-solid,
- solid dissolves in mouth.
- The claim does not specify which viscosity measurement applies, but it still requires a second viscosity-increasing excipient plus the stated w/v range.
C. Palatability excipient
- “First excipient that improves the palatability” is broad by function (not limited to a specific chemical class), but it must be present.
- Claim 11-12 then defines a “sweetening agent” version with a long enumerated list.
D. Viscosity excipient recitations
- Claim 1 defines the amount of “one or more of a second excipient” increasing viscosity:
- about 25% w/v to about 60% w/v.
- This is a major scope driver: it sets a concentration window that would be difficult for a competitor to avoid if they use viscosity agents in that band and meet other limitations.
E. Unit-dose structure
- “Formulated in a unit dose formulation for oral administration” plus the claimed dosage-form volume range appears in claim 10, not in claim 1.
F. Sensory viscosity
- “Nectar-like to honey-like” is a functional/rheological descriptor. The term is limiting but can be argued as subjective unless the patent defines measurement methods in the specification (not provided in your prompt).
Claim 1: functional breadth with practical constraints
- Breadth: active ingredient set is only two drugs, but the “first excipient that improves palatability” can be met by many taste-masking/sweetening systems, and the dosage-form category is multi-modal.
- Constraints: the viscosity excipient amount range (25–60% w/v) and the unit-dose formulation anchor limit design-around space.
How do dependent claims narrow or broaden claim 1?
Palatability narrowing: claims 11-12
- If an accused product uses a sweetening agent as the palatability excipient, claim 12 lists sugars/polyols and sweeteners (e.g., sucrose, lactose, dextrose, sorbitol, xylitol, sucralose, and even honey).
- The enumeration increases enforceability against formulations using common sweeteners, but the dependent claim set also implies that claim 11’s “palatability excipient” can include more than sweeteners.
Viscosity excipient narrowing: claims 2 and 14
- These dependents restrict the viscosity excipient class to:
- maltodextrin, carboxymethyl cellulose, microcrystalline cellulose, or combinations.
Dosage form narrowing: claim 3-4 and claim 24
- Claim 3 forces the dosage form to an aqueous suspension.
- Claim 4 narrows solid dosage forms to dissolving tablet or dissolving wafer.
- Claim 24 explicitly covers semi-solid or mouth-dissolving solid as alternative claim scope.
Dosing frequency limits: claims 5-6
- “Suitable for once a day administration” and “administered no more than once a day.”
- These are practical-limiting but can be challenged depending on labeling and regimen claims. They still create a design-around lever: a competitor could target an alternative schedule, but that does not necessarily avoid composition infringement if the formulation is still used once daily in the market.
Dosage amount ranges: claims 7-8 and 16-17 and 22-23
- Claim 7: 0.01 mg to 10 mg corticosteroid per unit dose (broad).
- Claim 8: 0.25 mg to 5 mg (narrower subset).
- Claim 16: same as claim 7 dependent set for claim 13 (again 0.01-10 mg).
- Claim 17: 0.25 mg to 5 mg.
- Claims 22-23 create additional sub-ranges:
- claim 22: 0.5 mg to 4 mg
- claim 23: 1 mg to 3 mg
These dose ranges are typical of oral anti-inflammatory regimens, but they also create meaningful “carve-out” opportunities if a competitor chooses a per-unit dose outside these bands.
Viscosity sensory descriptor: claims 9 and 15
- “Nectar-like to honey-like.”
- If the specification includes a viscosity measurement map to “nectar-like/honey-like,” that term can become objectively limiting. Without that map, it still anchors a rheological design target.
How does claim 13 change the scope: viscosity measured to a specific cP at defined conditions?
Claim 13 is an independent claim with a tighter rheological definition. It is narrower than claim 1 because it adds an objective viscosity threshold and specifies an aqueous suspension.
Claim 13 distinguishing limitations
- Active: budesonide or fluticasone (same restricted set).
- Palatability excipient: required.
- Viscosity requirement:
- “one or more of a second excipient in an amount” increasing viscosity
- to at least about 25 cP at 25° C. and shear rate 13.2 s−1.
- Dosage form: explicitly aqueous suspension.
- Unit dose volume: ~5 mL to ~15 mL.
Practical effect
- Claim 13 is enforceable against formulations that hit the rheology target, even if they do not match the 25–60% w/v concentration language of claim 1 (depending on whether claim 13’s viscosity excipient amount is still tied to a w/v range in the full text).
- Competitor formulations can attempt design-around by adjusting viscosity below 25 cP at the stated conditions, but that also risks losing the “nectar-like to honey-like” sensory behavior recited elsewhere.
How many claim “routes” exist for infringement? (useful for freedom-to-operate mapping)
At a high level, the patent gives multiple overlapping ways to fall within scope:
-
Composition type route (claim 1): aqueous suspension, semi-solid, or dissolving mouth solids, with:
- budesonide/fluticasone
- palatability excipient
- viscosity-excipient at 25–60% w/v
- unit-dose oral format.
-
Rheology route (claim 13 + dependents): aqueous suspension + ≥25 cP at specified conditions + unit-dose volume.
-
Taste route (claim 11-12): if palatability excipient is a sweetener from the listed set.
-
Dose route (claims 7-8, 16-17, 22-23): formulation dosage per unit within recited mg bands.
-
Solid-dosage route (claim 4): dissolving tablet or wafer.
-
Schedule route (claims 5-6): once daily or no more than once daily.
This multi-route architecture increases the chance that an accused product meets at least one independent pathway, but infringement still requires every limitation within whichever claim is asserted.
What is the likely patent estate focus: formulations, palatability, and viscosity modifiers?
The claim set is a strong indicator that the patent family focuses on oral delivery of budesonide/fluticasone using taste and rheology engineering. The specific excipient list (maltodextrin, CMC, microcrystalline cellulose) suggests a formulation strategy aimed at:
- masking steroid taste,
- stabilizing suspension and/or mouthfeel,
- tuning viscosity for acceptability and dosing uniformity.
This is not a “new steroid” patent; it is an oral dosage form design patent.
What patents protect oral budesonide or oral fluticasone with viscosity/taste excipients in the US?
A complete landscape requires the actual patent bibliographic data, family members, and Orange Book listings tied to US marketing authorizations. Your prompt provides only the claims text and not:
- patent publication number,
- assignee,
- filing/grant dates,
- priority dates,
- related patents in the same family,
- referenced applications or continuations,
- FDA product links.
Without those anchor facts, a defensible “patent numbers and expiration dates” landscape cannot be produced with the precision required for licensing or litigation decisions.
Per the constraints, no incomplete landscape is provided.
When does US Drug Patent 11,197,822 lose exclusivity?
A defensible exclusivity timeline depends on:
- filing date (20-year term),
- priority chain,
- PTA (patent term adjustment),
- any FDA exclusivity (5-year New Chemical Entity, 3-year new clinical, etc.),
- whether the patent is listed in the Orange Book and against what NDA/ANDA/BLA.
Those inputs are not contained in the prompt. No exclusivity timeline is produced.
What generic entry risks exist for oral budesonide/fluticasone unit-dose viscous suspensions under Paragraph IV?
Paragraph IV risk assessment requires knowing:
- the Orange Book listing(s) for the implicated product,
- the reference listed drug (RLD),
- the specific listed patents per NDA/ANDA,
- which claims (composition vs method-of-use) appear on the Orange Book,
- whether the asserted claims are formulation-only (as here) or also method-of-use.
Those listing facts are not provided. No scenario is produced.
What is the Orange Book status of US Drug Patent 11,197,822?
Orange Book status is not inferable from the claim text alone. No listing determination is provided.
How strong is the patent’s enforceability based on claim construction leverage?
Even without the specification, the claim language shows several enforceability strengths:
-
Objective viscosity anchor in claim 13
The recitation of 25 cP at 25° C. and shear rate 13.2 s−1 creates a measurable infringement hook. If the specification supports a defined measurement method, enforcement leverage increases.
-
Concentration window in claim 1
The 25–60% w/v range for viscosity excipient limits design-around by forcing a narrow formulation target.
-
Narrow active ingredient set
Restriction to budesonide and fluticasone reduces prior art breadth but also focuses enforcement and claim validity analysis on those specific steroids.
-
Multiple overlapping dependent claims
Dose ranges, unit dose volume, dosing cadence, and specific excipient exemplars can create multiple infringement theories.
Where enforceability can weaken:
- If “nectar-like to honey-like” depends on subjective descriptors without objective mapping, challengers can attack indefiniteness or argue non-coverage.
- Palatability excipient “improves palatability” is functional and can be disputed if a competitor uses an alternative taste-masking approach.
Which formulation design-arounds are plausibly outside the claim scope?
Given the claim recitations, practical design-around levers include:
- Use a corticosteroid outside budesonide/fluticasone.
- Avoid aqueous suspension, semi-solid, and dissolving-in-mouth formats if those correspond to the full claim definitions (though claim 1 already covers multiple formats, so design-around must be more radical).
- Use viscosity excipients outside the required concentration window (claim 1’s 25–60% w/v) and/or avoid meeting ≥25 cP at 25° C., 13.2 s−1 (claim 13).
- Move dose outside the mg/unit ranges recited in dependent claims being asserted.
- Alter unit dose volume outside 5–15 mL (claim 10 and claim 13).
- Remove the palatability excipient limitation by using a different formulation strategy (though practically, most oral suspensions require some taste-masking component).
These levers are derived from the claim language you supplied; whether they work depends on the final accused product composition, rheology testing, labeling, and unit-dose configuration.
Key Takeaways
- US 11,197,822 covers oral unit-dose formulations of budesonide and/or fluticasone with taste/palatability excipients and viscosity-increasing second excipients, delivered as aqueous suspension, semi-solid, or mouth-dissolving solids.
- Claim 1 uses a 25–60% w/v viscosity excipient concentration window and broad “palatability excipient” functional language.
- Claim 13 tightens enforceability with an objective viscosity threshold: ≥25 cP at 25° C. with 13.2 s−1 shear rate, and requires an aqueous suspension plus 5–15 mL unit dose.
- Dependent claims narrow with specific viscosity excipients (maltodextrin, CMC, microcrystalline cellulose), sweetener lists, dose ranges, once-daily suitability, and dissolving tablet/wafer forms.
- A full US landscape (family members, Orange Book listing status, expiration dates, and Paragraph IV risk) cannot be constructed from the prompt alone.
FAQs
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Does US 11,197,822 cover buccal or topical (non-oral) corticosteroid formulations of budesonide or fluticasone?
The claims are limited to an oral dosage form.
-
What excipients are explicitly identified as increasing viscosity?
The dependents identify maltodextrin, carboxymethyl cellulose, microcrystalline cellulose, or combinations.
-
What viscosity measurement conditions are recited in the patent claims?
Claim 13 recites at least about 25 cP at 25° C. and shear rate 13.2 s−1.
-
Are once-daily dosing claims mandatory for infringement?
Those are in dependent claims (claims 5-6). If asserted, they add a limiting regimen element beyond composition.
-
Can a competitor avoid infringement by changing only the unit dose volume or drug dose within the allowed ranges?
The claims recite specific ranges in dependent claims (e.g., 5–15 mL and 0.01–10 mg plus narrower subsets). Shifting outside asserted ranges is a direct design-around lever under the claim language.
References (APA)
No cited sources were used.
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