United States Patent US 10,751,333: Scope, Claims, and Patent Landscape for Omeprazole Reconstitution Compositions

US 10,751,333 claims a reconstitution and suspension system for omeprazole built around a specific liquid diluent formulation and performance criteria (30-day stability, freeze-thaw resistance, homogeneity), plus dependent claim fallbacks that pin excipient concentrations and optional organoleptic/color components. The claim set is tightly chemistry-and-performance oriented (a defined diluent with “consisting essentially of” limits), then expands scope into (i) a homogenous omeprazole suspension made using that diluent, and (ii) a kit that contains separate omeprazole powder and the diluent and defines reconstitution performance (fast dissolution assay, stable homogenous suspension).

What does US 10,751,333 claim in plain scope terms?

The independent claims cover four related subject matters:

1) Liquid diluent for reconstituting omeprazole (claim 1).
2) Suspension of omeprazole that includes the same excipient system and performance shelf-life (claim 17; and “consisting essentially of” claim 23).
3) Kit containing omeprazole powder plus the liquid diluent and defining reconstitution and stability outcomes (claim 24; plus dissolution assay threshold in claim 25).

The remaining claims are numerical and add-on limitations that narrow the independent formulations by specifying particular ranges or exact concentrations for poloxamer 188, CMC, bicarbonate, citrate, simethicone, benzyl alcohol, sweetener system, plus optional color and flavor.

Independent claim 1 (core diluent composition + stability/performance)

Claim 1 defines a diluent that “consist[s] essentially of”:

Poloxamer 188: 1.0% to 4.0% w/v
Sodium carboxymethylcellulose (CMC): 1.0% to 2.0% w/v
Sodium bicarbonate: 8.0% to 8.8% w/v
Sodium citrate: 0.5% to 1.5% w/v
Simethicone emulsion: 0.1% to 0.3% w/v
Sweetener: 0.35% to 3.5% w/v
Preservative: 0.4% to 0.6% w/v benzyl alcohol
Water

It adds two performance requirements:

Stability for at least 30 days
Resistant to gel formation for at least one freeze-thaw cycle

Dependent claim cluster (range-to-point narrowing)

Claims 2–5 specify poloxamer concentration at 1%, 2%, or 4% w/v.
Claim 5 specifies CMC at 1.2% w/v.
Claim 10 specifies sodium bicarbonate at 8.4% w/v.
Claims 11–15 pin sodium citrate at 1.0% w/v and define simethicone at 0.15% w/v plus a specific sweetener system: 70% sorbitol solution and sucralose, with example amounts (2.5% sorbitol solution and 0.4% sucralose).
Claim 16 pins benzyl alcohol at 0.5% w/v.

Claims 6–9 add optional FD&C Red No. 40 and a strawberry flavor:

Red 40: 0.002% to 0.005% w/v; with example 0.003% w/v
Strawberry Flavor CW08: 0.1% to 0.2% w/v; with example 0.15% w/v

Independent claim 17 (homogenous omeprazole suspension + shelf-life)

Claim 17 covers an omeprazole suspension “consisting essentially of”:

omeprazole + the same excipient group: poloxamer 188, sodium CMC, sodium bicarbonate, sodium citrate, simethicone emulsion, benzyl alcohol, sweetener, water
plus performance: homogenous and stable for at least 30 days at ambient and refrigerated conditions.

Claims 18–22 further constrain poloxamer and CMC ranges, including a combined range-limitation version (claim 22).

Independent claim 23 (explicit “consisting essentially of” formula for suspension)

Claim 23 is a full formula restatement with tight ranges and explicit upper/lower limits for each component, including the benzyl alcohol band 0.4% to 0.6% w/v.

Independent claim 24 (kit with reconstitution performance outcomes)

Claim 24 defines:

A first container with 100% w/w omeprazole powder
A second container with a liquid diluent consisting essentially of the defined excipient package (same as claim 1)
Diluent stability: 30 days and freeze-thaw gel resistance
Reconstitution in either container to produce a reconstituted omeprazole suspension
Reconstituted suspension: homogenous and stable for at least 30 days at ambient and refrigerated conditions.

Dependent kit outcome and composition limitations

Claim 25 adds a quantitative dissolution assay: “percent of omeprazole powder dissolved” is >80% after 5 minutes of mixing.
Claim 26 links poloxamer and CMC ranges in the reconstituted suspension (1.0% to 4.0% poloxamer; 1.0% to 2.0% CMC).
Claim 27 provides a specific “diluent consists essentially of” example batch:
- poloxamer 188 1.0% w/v
- sodium CMC 1.2% w/v
- sodium bicarbonate 8.4% w/v
- sodium citrate 1.0% w/v
- benzyl alcohol 0.5% w/v
- simethicone emulsion 0.15% w/v
Claim 28 defines sweetener components for the kit example:
- 2.5% w/v sorbitol solution (70%)
- 0.4% w/v sucralose

How is the claim language likely to define infringement boundaries?

1) “Consisting essentially of” constrains allowable substitutions

Each main composition claim uses “consisting essentially of,” not “comprising.” That typically:

permits only ingredients that do not materially alter the basic and novel characteristics, and
blocks broader dilution where extra actives, alternative preservatives, or different gel-control systems materially affect function.

2) Numeric excipient ranges and specific subranges are doing the heavy lifting

The diluent is not generic “buffers + surfactant.” It is a defined combination with explicit bands:

poloxamer 188 (1.0% to 4.0% w/v)
CMC (1.0% to 2.0% w/v)
bicarbonate (8.0% to 8.8% w/v)
citrate (0.5% to 1.5% w/v)
simethicone emulsion (0.1% to 0.3% w/v)
benzyl alcohol (0.4% to 0.6% w/v)

Even if an accused product uses the same components, off-range concentrations can matter, especially for claims that recite exact examples (e.g., 1% poloxamer, 8.4% bicarbonate, 1.2% CMC).

3) The freeze-thaw and gel-resistance criteria add a functional performance gate

Claim 1 includes “resistant to gel formation for at least one freeze-thaw cycle” and “stable for at least 30 days.”
Claim 24 and 17 also lock in “stable for at least 30 days” and “homogenous,” plus temperature conditions in claim 17/24.

This creates a practical enforcement posture:

a product with the excipient chemistry but poor freeze-thaw performance may argue design-around;
conversely, a product with slightly different concentrations may still capture if it remains within the claimed “consisting essentially of” bounds and meets performance.

4) Kit claim creates an additional infringement surface

A generic competitor could potentially sell:

the diluent separately, or
the suspension separately, or
a kit.

Claim 24 requires the two-container arrangement with reconstitution performance outcomes, plus the “100% w/w omeprazole powder” in container one. That makes kits an especially direct target.

What are the full claim-by-claim content maps (composition and performance)?

A. Liquid diluent (claim 1 and dependents)

Component	Claim 1 range (w/v)	Key dependents / examples
Poloxamer 188	1.0% to 4.0%	Claim 2: 1%; Claim 3: 2%; Claim 4: 4%
Sodium CMC	1.0% to 2.0%	Claim 5: 1.2%
Sodium bicarbonate	8.0% to 8.8%	Claim 10: 8.4%
Sodium citrate	0.5% to 1.5%	Claim 11: 1.0%
Simethicone emulsion	0.1% to 0.3%	Claim 12: 0.15%
Sweetener	0.35% to 3.5%	Claim 13: includes 70% sorbitol + sucralose; Claims 14–15 give amounts
Preservative	0.4% to 0.6%	Claim 16: benzyl alcohol 0.5%
Coloring (optional)	N/A	Claim 6: FD&C Red 40 0.002%–0.005%; Claim 7: 0.003%
Flavor (optional)	N/A	Claim 8: strawberry flavor CW08 0.1%–0.2%; Claim 9: 0.15%
Water	balance	implied

Performance in claim 1:

Stable ≥ 30 days
Resistant to gel formation for ≥ one freeze-thaw cycle

B. Omeprazole suspension (claims 17 and 23 + dependents)

Feature	Claim 17	Claim 23
“Consisting essentially of”	yes	yes
Components	omeprazole + same excipient set	same, explicit range restatement
Homogeneity/stability	homogenous and stable ≥ 30 days at ambient and refrigerated	not separately restated in 23 (composition + “consisting essentially of”)
Poloxamer band	1.0%–4.0% (via claim 18; and explicit in claim 23)	1.0%–4.0%
CMC band	1.0%–2.0% (via claim 20; and explicit in claim 23)	1.0%–2.0%
Example constraints	18–22	via claim 23 composition only
Full composition with ranges	not fully tabulated in 17	fully in 23 (including benzyl alcohol 0.4%–0.6%)

C. Kit (claim 24 + dependents 25–28)

Kit element	Claim 24 requirement	Dependents
Container 1	100% w/w omeprazole powder	none
Container 2	diluent “consisting essentially of” listed excipients + water	claim 27 gives specific diluent example
Diluent performance	stable ≥ 30 days; freeze-thaw gel resistance ≥ one cycle	none
Reconstitution	can combine to produce reconstituted omeprazole suspension (either container)	none
Reconstituted suspension performance	homogenous and stable ≥ 30 days at ambient and refrigerated	none
Dissolution outcome	not required in 24	claim 25: >80% dissolved after 5 minutes
Composition constraints in suspension	not specified numerically in 24	claim 26: poloxamer 1.0%–4.0%; CMC 1.0%–2.0%
Example diluent batch	not specified in 24	claim 27: poloxamer 1.0%; CMC 1.2%; bicarbonate 8.4%; citrate 1.0%; benzyl alcohol 0.5%; simethicone 0.15%
Sweetener in example	not specified in 24	claim 28: 2.5% sorbitol solution (70%) + 0.4% sucralose

What claim strategy does this set reflect?

US 10,751,333 is structured to cover both:

the formulation (diluent and resulting suspension), and
the product configuration (kit) with a fast dissolution outcome.

The drafting uses a layered dependency model:

start broad with composition and functional performance (claim 1, claim 17, claim 24),
then nail the most likely competitive designs with narrower concentration claims (claims 2–5, 10–12, 14–16, 18–22, 26–28),
then broaden the market reach with optional organoleptic embodiments (claims 6–9) that may make the claimed system commercially attractive.

How does this patent likely sit in the broader US omeprazole formulation landscape?

Given only the claim text provided, the landscape analysis must be claim-structure based rather than citation-based. The core technical novelty, as drafted, is the combination of:

a specific surfactant system (poloxamer 188 at 1.0%–4.0% w/v),
a controlled viscosity/aggregation stabilizer (sodium CMC at 1.0%–2.0% w/v),
gas management / antifoaming relief (simethicone emulsion at 0.1%–0.3% w/v),
a buffering regime using sodium bicarbonate (8.0%–8.8% w/v) and sodium citrate (0.5%–1.5% w/v),
and a preservative choice (benzyl alcohol 0.4%–0.6% w/v),
while meeting explicit freeze-thaw gel resistance and 30-day ambient + refrigerated stability/homogeneity outcomes.

Practical competitive interpretation

If a competitor uses an omeprazole suspension with bicarbonate/citrate buffering, CMC thickener, and a surfactant, US 10,751,333 still targets the exact pairing of poloxamer 188 and the specific excipient bands, plus gel resistance and shelf-life outcomes.
If a competitor uses a different poloxamer grade or a different surfactant class, they may avoid claims 1/17/23 unless equivalency arguments succeed.
If a competitor replaces benzyl alcohol with another preservative, they may exit the “benzyl alcohol” band limitation; the claims are explicit that the preservative is benzyl alcohol.

Design-around pressure points (based on the claim limits)

1) Freeze-thaw and gel formation

Claim 1 makes freeze-thaw gel resistance a limitation. If a competitor changes excipient ratios to avoid gelation, it may still land outside performance even if the chemistry overlaps.

2) Exact preservative identification

Benzyl alcohol at 0.4%–0.6% w/v is a concrete constraint across claim 1 and claim 23. Another preservative (or no preservative) can break dependence.

3) Simethicone inclusion

Simethicone emulsion is constrained to 0.1%–0.3% w/v. Omitting simethicone or replacing it with a different antifoam system is a direct design-around axis.

4) Kit-specific dissolution requirement

Claim 25 adds a measurable endpoint: “>80% by dissolution assay after 5 minutes.” A competitor who meets shelf-life but not fast dissolution can potentially avoid claim 25 while still facing claim 24.

Key Takeaways

US 10,751,333 is centered on a defined omeprazole reconstitution system with specific excipient bands and two performance gates: ≥30-day stability and freeze-thaw gel resistance (claim 1) plus homogeneity/stability at ambient and refrigerated (claims 17 and 24).
The enforceable core is the liquid diluent composition (claim 1) using “consisting essentially of,” anchored by poloxamer 188 + sodium CMC + bicarbonate/citrate buffering + simethicone emulsion + benzyl alcohol.
The claim set expands protection into product form (homogenous omeprazole suspension, claim 17/23) and distribution configuration (two-container kit, claim 24) with an added quantitative dissolution performance element in claim 25.
Dependent claims narrow the “likely real-world commercial embodiments” by specifying example concentration points for poloxamer, CMC, bicarbonate, citrate, simethicone, benzyl alcohol, and a specific sweetener system (70% sorbitol solution plus sucralose), plus optional red/flavor additions.

FAQs

1) Does US 10,751,333 protect only kits or also standalone diluent/suspension products?
It protects the liquid diluent (claim 1), the reconstituted omeprazole suspension (claim 17 and claim 23), and a two-container kit (claim 24).

2) What makes claim 1 different from a typical buffered, thickened diluent?
Claim 1 ties a specific excipient combination to functional performance: stability for at least 30 days and resistance to gel formation for at least one freeze-thaw cycle.

3) How tight are the preservative limitations?
Benzyl alcohol is required as the preservative, at 0.4% to 0.6% w/v (with claim 16 specifying 0.5%).

4) What is the main quantitative performance metric in the kit claims?
Claim 25 requires >80% dissolution after 5 minutes by dissolution assay.

5) What sweetener system is explicitly claimed?
Claim 13–15 specify a sweetener comprising 70% sorbitol solution and sucralose, with example amounts of 2.5% w/v sorbitol solution and 0.4% w/v sucralose.

References

[1] US 10,751,333 (claims 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
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y				⤷ 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
Canada	3147586	⤷ Start Trial
China	114761002	⤷ Start Trial
European Patent Office	3999066	⤷ Start Trial
Mexico	2022000623	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2021011669	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,751,333

Which drugs does patent 10,751,333 protect, and when does it expire?

Summary for Patent: 10,751,333