Details for Patent: 12,594,298

Which drugs does patent 12,594,298 protect, and when does it expire?

Patent 12,594,298 protects SUFLAVE and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 12,594,298

Title:	Methods of administering safe colon cleansing compositions
Abstract:	Disclosed herein are methods of administering compositions comprising a mixture of salts that induce purgation of the colon and are useful to cleanse the colon. Furthermore, the disclosed methods prevent degradation of PEG and allow for cleansing of the colon without the use of adjunct laxatives, including stimulant laxatives such as bisacodyl. The disclosed methods are superior to the prior art in that they allow for higher tolerability, improved safety, lower volumes, and improved patient compliance.
Inventor(s):	Edmund V. Dennett, Mark Cleveland, Russell W. Pelham, Matthew Walker
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US19/172,077
Patent Claim Types: see list of patent claims	Compound;

Patent 12,594,298 Scope and Claims: What the PEG 3350/Sodium Sulfate/Malic-Citric “Two-Dose, Four-Container” Colon Cleansing System Protects

United States Patent No. 12,594,298 has a narrowly structured claim set centered on a colon cleansing kit/system that separates (i) PEG 3350 with electrolyte salts (sodium sulfate, potassium chloride, magnesium sulfate, sodium chloride) from (ii) a malic acid and citric acid acid component, and requires a specific in-use sodium-balance performance threshold tied to combining the first and second doses.

The operative protection is not “PEG colonoscopy prep” in general. It is the specific multi-container dosing architecture plus a defined formulation composition and a functional clinical constraint (no sodium balance of −50.00 mEq/L or greater).

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What does US 12,594,298 claim protect for colon cleansing products?

Direct answer: The patent protects a colon cleansing product kit where the PEG 3350 + sulfate/chloride salts are split between two containers that together form “a first dose,” and the malic acid + citric acid are split between two other containers that together form “a second dose,” with a performance limitation that the combined first and second doses cleanse the colon without causing sodium balance worse than −50.00 mEq/L (threshold framing in the claims).

Claim 1: Core system limitation and performance threshold

Claim 1 is the centerpiece and reads like a kit claim with structural and functional constraints:

1. Four-container system that maps to two doses

   • First container: first portion of the first dose with:
     • PEG 3350 about 178.7 g
     • sodium sulfate about 7.3 g
     • potassium chloride about 1.12 g
     • magnesium sulfate about 0.9 g
     • sodium chloride about 0.5 g
   • Second container: second portion of the first dose with:
     • malic acid and citric acid (no numeric amounts in Claim 1)
   • Third container: first portion of the second dose with the same PEG/electrolyte quantities as the first container:
     • PEG 3350 about 178.7 g
     • sodium sulfate about 7.3 g
     • potassium chloride about 1.12 g
     • magnesium sulfate about 0.9 g
     • sodium chloride about 0.5 g
   • Fourth container: second portion of the second dose with:
     • malic acid and citric acid (no numeric amounts in Claim 1)

2. Functional limitation tied to sodium balance

   • The formulation is “so that the combination of the first dose and second dose cleanse a colon of a subject without causing a sodium balance of −50.00 mEq/L or greater in the subject.”

Practical scope effect: To infringe Claim 1, a product must match:

• the two-dose, four-container architecture, and
• the PEG 3350 + electrolytes amounts specified for each “first portion” container, and
• the presence of malic acid + citric acid in the “second portion” containers, and
• the functional sodium-balance outcome as recited.

Claim 2 and Claim 3: Numeric acid composition tightening

Claim 2 depends on Claim 1 and adds numeric acid amounts for the malic/citric portion of the first dose:

• Second portion of the first dose comprises about:
  • 1.43 g malic acid
  • 1.64 g citric acid

Claim 3 depends on Claim 2 (and thus on Claim 1) and repeats the same numeric acid amounts for the second dose:

• Second portion of the second dose comprises about:
  • 1.43 g malic acid
  • 1.64 g citric acid

Practical scope effect: Claim 2 and 3 narrow the protected formulations by requiring not just malic + citric acids, but their specific approximate quantities per dose portion.

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How does the “four-container, two-dose” structure limit claim breadth vs standard colon cleansing sachets?

Direct answer: Claim 1 is drafted as a kit/system claim with strict container partitioning tied to two doses. Standard colon cleansing products that deliver one premixed sachet per dose, or that do not partition electrolytes from acid components across multiple containers, typically fall outside the literal kit architecture.

Key architectural elements that drive infringement risk

• Partitioning: PEG/electrolyte salts are in a “first portion” container; malic/citric acids are in a “second portion” container.
• Dose repetition: This structure is replicated for a “second dose” with analogous amounts.
• Count and placement: Claim 1 explicitly requires a first container, second container, third container, fourth container.

What kinds of products would most likely avoid literal scope

• Single-container per dose products that combine PEG 3350, sulfate salts, and acids into one container per dose (no four-container partition).
• Products that have different acid systems (for example, different organic acids or buffers) rather than malic acid and citric acid.
• Products where PEG 3350 and sodium sulfate/potassium chloride/magnesium sulfate/sodium chloride amounts are outside the “about” ranges (Claim 1 ties to specific quantities).
• Products that meet sodium-balance performance but not the kit architecture.

What kinds of products could still be within scope

• Products that use a four-container kit and split “PEG/electrolytes” from “malic/citric acids” for both doses.
• Products that match the approximate grams of PEG 3350 and the salt quantities, even if the dosing instructions differ, provided the kit still yields the claimed dosing combination.
• Products that match the performance outcome as defined by the sodium-balance threshold.

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What is the scope of the sodium balance limitation in Claim 1, and how does it change infringement?

Direct answer: Claim 1 requires a colon cleansing outcome without causing sodium balance at or above −50.00 mEq/L (as recited). This is a functional performance limitation that can become a central infringement and litigation issue.

How the sodium-balance limitation is likely used in practice

• It creates a measurable clinical/evaluation parameter that can be used to argue whether accused products satisfy or do not satisfy the performance constraint.
• It can shift the dispute toward:
  • product-specific clinical data,
  • bridging studies,
  • trial endpoints tied to sodium balance.

Infringement posture

• A plaintiff typically pairs kit/formulation similarity with clinical evidence that the product prevents sodium balance from reaching the claimed threshold.
• A defendant typically argues either:
  • the kit does not match the container/formulation structure, or
  • the product’s sodium balance profile in its labeled regimen does not satisfy the claim’s “without causing” condition.

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What formulations are specifically recited: PEG 3350 and electrolytes plus malic/citric acid?

Direct answer: Claim 1 recites a PEG 3350-based electrolyte solution composition per “first portion” container, plus malic/citric acid in the “second portion” containers; Claims 2 and 3 specify the malic/citric gram amounts.

Claim 1 “first portion” composition (per first and third containers)

• PEG 3350: about 178.7 g
• sodium sulfate: about 7.3 g
• potassium chloride: about 1.12 g
• magnesium sulfate: about 0.9 g
• sodium chloride: about 0.5 g

Claim 1 “second portion” composition (per second and fourth containers)

• malic acid: included (amount unspecified in Claim 1)
• citric acid: included (amount unspecified in Claim 1)

Claims 2-3 malic/citric quantities

• malic acid about 1.43 g
• citric acid about 1.64 g for each “second portion” container corresponding to each dose.

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Which parts of the claim are likely to be central in litigation over infringement?

Direct answer: The four-container mapping (container count and partitioning), the specific PEG/electrolyte quantities in the PEG portion, and the malic/citric acid presence and amounts (Claims 2-3) are likely to be the most direct infringement map points; the sodium-balance threshold is the key performance constraint.

Most litigated claim “map points”

1. Container count and identity
   • First vs second vs third vs fourth containers
2. Per-container composition
   • PEG 3350 and each salt amount in first/third containers
3. Presence and amounts of acids
   • malic/citric acids in second/fourth containers
4. Outcome evidence
   • whether dosing results in sodium balance meeting the threshold

Most likely defenses

• Non-infringement on container partitioning (e.g., different kit assembly).
• Composition drift: different PEG/electrolyte gram amounts.
• Acid system mismatch: acids not malic plus citric.
• Sodium balance mismatch: no “without causing” result based on dosing regimen and data.

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What does the claim structure imply about “kit assembly” and non-technical infringement theories?

Direct answer: Because Claim 1 explicitly requires a multi-container product, infringement analysis often turns on packaging configuration and dosing kit instructions rather than only chemical composition.

Packaging and labeling as evidence

• Product packaging showing multiple containers that correspond to the four containers recited.
• Instructions tying container contents to the “first dose” and “second dose” regimen.

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How strong is the patent estate for this concept: what does a narrow Claim 1 suggest?

Direct answer: Based solely on the claims provided, the patent appears strongly anchored to a specific formulation architecture and performance constraint, which tends to narrow literal coverage but can increase validity defensibility if the novelty resides in the specific kit and sodium balance problem addressed.

Strength indicators from the claim language

• Specific quantitative PEG/electrolyte amounts
• Explicit container architecture
• Explicit malic + citric acid partitioning
• Explicit sodium balance limitation
• Dependent claims add specific acid quantities

Weakness indicators from the claim language

• Literal scope is narrow: competitors can design around by altering container partitioning, switching acid systems, or shifting compositions away from recited quantities.
• Performance limitation may require proving clinical endpoints, which can increase evidentiary burden.

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What generic entry risks exist for products that resemble PEG 3350 colon cleansing regimens but with different kit formats?

Direct answer: The risk is highest for products that adopt the same four-container split architecture and the same PEG/electrolyte composition amounts, and that use malic and citric acids in the specific quantities (Claims 2-3). Risk decreases substantially for single-sachet or different-acid systems.

High-risk design-around profiles

• PEG 3350-based products with sodium sulfate/potassium chloride/magnesium sulfate/sodium chloride and malic/citric acids, configured as two-dose kits with split acid and PEG portions.

Lower-risk profiles

• Altered container count or dose partitioning.
• Different acids or buffers.
• Significant deviations from the recited PEG/electrolyte quantities.

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What patents typically co-exist with claims like this (formulation, method, and kit assembly)?

Direct answer: For PEG-based colon cleansing, it is common to see a landscape where:

• one set of patents covers formulations (PEG + electrolytes + acid additives),
• another set covers kit assembly and dosing regimens,
• another set covers manufacturing and mixing approaches,
• another set covers clinical performance metrics like electrolyte balance.

This patent’s claim text already blends formulation and kit architecture with a clinical performance outcome, so the most relevant neighboring estate members in litigation would be those targeting either:

• the same kit architecture with different acid ratios or PEG/electrolyte ranges, or
• method-of-use claims covering administration regimens.

Note: Only the specific claim text for US 12,594,298 is provided here; no additional family or citation data is included in the input, so a complete mapping of related US or foreign patents cannot be produced.

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What is the likely scope of US 12,594,298 outside the exact numbers: does “about” broaden protection?

Direct answer: The term “about” introduces tolerance around recited quantities, but the claim still anchors infringement to the same formulation components and approximate amounts. Design-around that materially changes PEG/electrolyte gram totals and acid quantities reduces infringement probability.

How “about” typically plays in claim interpretation

• Courts treat “about” as a flexibility band, but it does not eliminate the need for substantial similarity.
• The more the competitor’s formulation drifts, the more likely it is to fall outside the tolerance.

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How does US 12,594,298 compare with typical PEG colonoscopy prep claim themes?

Direct answer: Standard PEG regimens often claim:

• the PEG plus electrolytes composition,
• the overall dosing regimen,
• sometimes flavoring or volume/salt balance.

This patent adds a specific acid partitioning and multi-container system plus a sodium balance threshold. That makes it more of a “performance-driven kit formulation” than a baseline PEG composition claim.

Where it likely overlaps in concept

• PEG 3350 colon cleansing regimens.
• Electrolyte-balanced bowel prep.

Where it likely diverges in protection

• explicit four-container split of PEG/electrolytes vs malic/citric acids,
• explicit sodium balance limitation,
• explicit acid masses (in dependent claims).

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Key takeaways

• US 12,594,298 Claim 1 protects a colon cleansing four-container kit that splits PEG 3350/electrolyte salts from malic acid + citric acid across the first and second portions of each dose, then imposes a functional sodium-balance ceiling (no sodium balance of −50.00 mEq/L or greater).
• Claims 2 and 3 narrow further by fixing malic acid and citric acid amounts to ~1.43 g malic acid and ~1.64 g citric acid in each acid-containing portion.
• The claim is narrow and architecture-dependent; design-arounds are most effective when they change container partitioning, acid system identity/amounts, or PEG/electrolyte quantities, and when sodium balance performance does not satisfy the functional threshold.

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FAQs

What must an accused product contain to infringe Claim 1 of US 12,594,298?

A four-container bowel cleansing kit with (i) PEG 3350 and specific salts in the first and third containers, (ii) malic acid and citric acid in the second and fourth containers, administered as a first and second dose, that achieves the claimed sodium-balance performance.

Do Claims 2 and 3 require malic and citric acids in specific gram amounts?

Yes. Claims 2 and 3 specify malic acid about 1.43 g and citric acid about 1.64 g in the acid-containing portion for the first and second doses, respectively.

If a competitor uses a different acid system, can it still infringe?

Claim 1 requires malic acid and citric acid in the acid portion containers. A different acid system would avoid the literal requirement.

Is the sodium balance limitation purely compositional, or does it require clinical evidence?

It is a functional performance limitation tied to a clinical/electrolyte outcome, which typically requires evidence from the accused dosing regimen.

What is the biggest design-around lever against US 12,594,298?

Changing either the four-container partitioning structure or the composition quantities (PEG/electrolytes and/or malic/citric acids), and ensuring the dosing regimen does not meet the claimed sodium balance threshold.

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References (APA)

1. United States Patent No. 12,594,298. Claims as provided in the prompt.

Drugs Protected by US Patent 12,594,298

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	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes	12,594,298		Y

International Family Members for US Patent 12,594,298

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2024256873