Scope and patent landscape for U.S. Drug Patent 11,771,686 (omeprazole reconstituted suspension with poloxamer/CMC/bicarbonate/simethicone/bzyl alcohol diluent)
U.S. Drug Patent 11,771,686 protects a method of ameliorating excess-stomach-acid gastrointestinal disorders in subjects with gastric ulcer using reconstituted omeprazole. The protection is tightly tied to a specific reconstitution liquid diluent composition and stability performance (≥30 days at 5±3°C, resistance to gel formation through at least one freeze-thaw cycle). Dependent claims further lock down specific concentration “windows,” optional flavor/color, and kit formats. The estate’s practical enforceability will hinge on whether an accused product uses (a) the same diluent excipient package and ranges, and (b) a substantially identical reconstituted suspension stability profile.

What patents protect omeprazole reconstitution suspensions for gastric ulcer in the U.S.?

Featured snippet answer: 11,771,686 claims are directed to reconstitution of omeprazole in a defined liquid diluent (poloxamer 188 + sodium CMC + sodium bicarbonate + sodium citrate + simethicone emulsion + sweetener + benzyl alcohol + water) with specific stability/anti-gel behavior, and to kit and mixing/administering methods.

How the independent claim frames infringement risk

Claim 1 (method) combines four technical/legal pillars:

Disease/condition limitation
“Gastrointestinal disorder… excess stomach acid” and the “subject has a gastric ulcer.”
Drug form and reconstitution step
“Administering a reconstituted omeprazole” where omeprazole is reconstituted “in a liquid diluent.”
Liquid diluent defined by ranges (substantially the core limitation)
- Poloxamer 188: 1.0% to 4.0% w/v
- Sodium 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
  (all “liquid diluent consists essentially of,” meaning additional ingredients are not excluded if they do not materially affect basic and novel properties, but the listed items are mandatory.)
Stability and anti-gel performance requirements
- “stable for at least 30 days at 5±3°C”
- “resistant to gel formation for at least one freeze-thaw cycle”

This structure means infringement analysis will often devolve into whether an accused reconstitution diluent is within the claimed excipient ranges and whether the reconstituted suspension meets the claimed stability/anti-gel metrics.

Key dependent claims that narrow claim scope

Claim 2: poloxamer 188 at 1%, 2%, or 4% w/v
Claim 3: sodium CMC at 1.2% w/v
Claim 4: optional FD&C Red No. 40 (0.002%–0.005% w/v) and Strawberry Flavor CW08 (0.1%–0.2% w/v)
Claim 5: sodium bicarbonate at 8.4% w/v
Claim 6: sodium citrate at 1% w/v
Claim 7: simethicone emulsion at 0.15% w/v
Claim 8–10: sweetener specific blend of 70% sorbitol solution + sucralose (with sucralose at 0.4% w/v and sorbitol solution at 2.5% w/v)
Claim 11: benzyl alcohol at 0.5% w/v
Claim 12 and 15: subjects that are child or elderly
Claim 13: kit format with two containers (omeprazole powder container and defined diluent container) and defined combining/production properties (homogeneous and stable ≥30 days at ambient and refrigerated temps)
Claim 14: dissolution performance: >80% dissolved after 5 minutes of mixing
Claims 16–26: method variations spelling out stepwise reconstitute and administer; repetition of several parameter dependences (poloxamer, CMC, bicarbonate, citrate, sweetener blend)

How broad is claim scope for the diluent composition and stability?

Featured snippet answer: The claim is broad on excipient “windows” (multiple ranges), but narrow on the specific excipient system and the stability/anti-gel constraints; it is medium-to-narrow commercially because many omeprazole liquid reconstitutions use different buffering/emulsion/preservative packages.

Diluent “consists essentially of” and what it implies for design-around

Claim 1 recites “liquid diluent consists essentially of” the listed excipients and water. In practice:

A manufacturer using the same core excipients but altering non-core ingredients may still face risk if the alteration changes the “basic and novel” properties associated with the claimed stability/anti-gel behavior.
Replacing one mandatory component (for example switching benzyl alcohol to methylparaben/propylparaben, or substituting a different polymer for CMC) is the cleanest way to reduce claim coverage but requires empirical stability and reconstitution performance.

Parameter matrix: where “gray zone” infringement sits

Component	Claim 1 range	Dependent locking points	Design-around pressure point
Poloxamer 188	1.0–4.0% w/v	1%, 2%, 4%	Medium: substituting a different surfactant can work but must maintain anti-gel performance
Sodium CMC	1.0–2.0% w/v	1.2%	High: CMC is a structural viscosity/anti-settling driver
Sodium bicarbonate	8.0–8.8% w/v	8.4%	High: buffering affects suspension pH and stability
Sodium citrate	0.5–1.5% w/v	1%	Medium: citrate can function as chelator/buffer
Simethicone emulsion	0.1–0.3% w/v	0.15%	Medium: emulsion affects mouthfeel and foaming; could be altered if stability maintained
Sweetener	0.35–3.5% w/v	70% sorbitol solution + sucralose (2.5% + 0.4% w/v)	Medium: changing sweetener system risks losing claimed “sweetener” dependency if used in ranges
Benzyl alcohol	0.4–0.6% w/v	0.5%	High: preservative swaps are common but reduce overlap
Stability	≥30 days at 5±3°C and anti-gel across freeze-thaw	Not expressly limited further	Very High: performance-based terms can be decisive

Stability terms turn “composition” claims into “process-performance” claims

Even if excipient concentrations are within range, accused products must contend with:

≥30 days at 5±3°C
resistant to gel formation for at least one freeze-thaw cycle

That shifts disputes toward analytical testing, comparability protocols, and documentation of formulation behavior during storage and temperature cycling.

When does U.S. Drug Patent 11,771,686 lose exclusivity?

Featured snippet answer: Exclusivity timing cannot be computed from the claim text alone. The determinative dates are the patent’s filing, priority, issuance, and any FDA-related exclusivity or patent term adjustment/extension, which are not provided in the prompt.

How strong is the patent estate for omeprazole reconstituted suspension kits?

Featured snippet answer: Within this single patent, enforceability is strongest for products that:

are sold as powder + liquid diluent kits or require a similar reconstitution workflow, and
use the same excipient system with overlapping ranges, and
document anti-gel and refrigerated stability consistent with the claim.

What claim 13 adds for enforceability against “kit” suppliers

Claim 13 is structurally enforceable against kit configurations:

first container contains “100% w/w omeprazole powder”
second container contains the defined liquid diluent
the container sizes allow combining in either container
the reconstituted suspension is homogeneous and stable ≥30 days at ambient and refrigerated temperatures

This is narrower than claim 1, but it targets the commercial packaging pattern common in pediatric or elder dosing products.

Claim 14 adds a measurable dissolution endpoint

Claim 14 requires that percent dissolved is >80% after 5 minutes of mixing (dissolution assay). This is an additional performance discriminator that can support a more quantitative infringement case.

What would a Paragraph IV challenge look like for this patent?

Featured snippet answer: A Paragraph IV filing would likely allege non-infringement and/or invalidity by arguing either (a) the generic reconstituted omeprazole uses a diluent outside the claimed “consists essentially of” composition ranges, and/or (b) the generic does not meet the claimed stability/anti-gel requirements, and/or (c) the claims are invalid over prior art on omeprazole suspensions and excipient systems.

Typical non-infringement theories for this claim family

Different preservative: not benzyl alcohol at 0.4–0.6% w/v
Different buffer system: sodium bicarbonate and/or citrate outside the ranges
Different polymer system: replacing sodium CMC
Different surfactant/emulsion system: poloxamer 188 range avoided; simethicone emulsion avoided
Stability failure: showing gel formation in freeze-thaw and/or reduced refrigerated stability

Typical validity theories

Prior art teaching the same diluent excipient system and similar stability outcomes for omeprazole or other acid-suppressing drugs
Obviousness arguments combining known excipients at known concentrations to achieve expected stability and anti-gel results
Written description/enablement: whether the patent specification supports the full breadth of the ranges and performance claims

Which companies are likely holders, and who would be sued?

Featured snippet answer: The assignee, current owner, AND likely ANDA filers or challengers are not provided in the prompt. Without those identifiers, a complete and accurate company-by-company landscape cannot be generated.

What FDA regulatory status ties to this patent?

Featured snippet answer: The Orange Book listing, NDA/BLA number, and whether the patent is listed as a method-of-use patent or formulation/compound-related patent cannot be determined from the provided claim text alone.

How does this patent compare with other omeprazole formulation patents?

Featured snippet answer: This patent’s distinguishing feature is the claimed combination of:

a defined poloxamer 188 + sodium CMC + sodium bicarbonate + sodium citrate + simethicone emulsion + benzyl alcohol + sweetener diluent system, and
explicit refrigerated stability and anti-gel freeze-thaw performance.

Compared to generic omeprazole formulation patents that typically claim the active plus dosage form without such performance-based excipient windows, 11,771,686 is more likely to be contested on formulation testing and on “consists essentially of” interpretation.

Key differentiator: anti-gel across freeze-thaw

Many formulation patents do not include explicit gel-formation resistance during freeze-thaw. Here it is a core claim element, raising the bar for any product using alternative excipients.

What generic entry risks exist for products that might sell omeprazole reconstituted suspensions?

Featured snippet answer: The highest entry risk exists for products whose commercial diluent:

replicates the excipient set with overlapping ranges,
uses benzyl alcohol as preservative at ~0.5% w/v, and
demonstrates ≥30-day refrigerated stability and freeze-thaw anti-gel behavior.

If a generic uses a materially different diluent system but can still achieve acid suppression and acceptable palatability/stability, it can reduce infringement exposure.

Key claim-to-design-around mapping (actionable)

Claim element	What an accused product must avoid	Practical formulation lever
Poloxamer 188 1–4% w/v	Use poloxamer outside range or switch surfactant	Surfactant redesign + stability testing
Sodium CMC 1–2% w/v	Replace CMC or reduce out of range	Polymer substitution
Sodium bicarbonate 8.0–8.8% w/v	Use different buffer/molarity	Buffer redesign and pH control
Sodium citrate 0.5–1.5% w/v	Swap citrate or change concentration	Chelator/buffer substitution
Simethicone emulsion 0.1–0.3% w/v	Remove or replace emulsion system	Emulsion/mouthfeel redesign
Sweetener 0.35–3.5% w/v; or specific sorbitol/sucralose	Use different sweetener or outside specific dependent blend	Taste system change
Benzyl alcohol 0.4–0.6% w/v	Use different preservative or different concentration	Preservation system change
Stable ≥30 days at 5±3°C; anti-gel freeze-thaw	Demonstrate gel formation or inadequate refrigerated stability	Storage and temperature cycling proof

Key Takeaways

11,771,686 is an omeprazole reconstitution-and-diluent performance patent. Coverage depends on using a reconstituted suspension with a defined excipient system and meeting ≥30 days stability at 5±3°C and anti-gel behavior through freeze-thaw.
The claim is range-based for excipient concentrations, but the ranges are anchored to a specific excipient package, with benzyl alcohol as a key preservative anchor.
Kit format (claim 13) and dissolution endpoint (claim 14) provide additional, testable footholds for enforcement against competitors replicating the commercial packaging and mixing performance.
Any generic entry strategy that targets non-infringement will likely rely on changing at least one mandatory excipient class (preservative, polymer, buffer, or emulsion) and on showing failure to meet stability/anti-gel criteria.

FAQs

If a generic omeprazole suspension uses a different preservative than benzyl alcohol, does it automatically avoid claim coverage?
How do courts typically interpret “consists essentially of” when additional excipients are present in the diluent?
Can a product infringe claim 1 if its excipient concentrations fall within ranges but its stability testing differs from the claimed performance conditions?
What is the litigation significance of claim 14’s “>80% dissolved after 5 minutes” mixing/dissolution requirement?
Do kit-format claims (claim 13) increase exposure for distributors and contract manufacturers who only supply the two containers?

References

U.S. Patent 11,771,686 (claims provided in 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	11,771,686	⤷ Start Trial				SHORT TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER	⤷ 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
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,771,686

Which drugs does patent 11,771,686 protect, and when does it expire?

Summary for Patent: 11,771,686