Details for Patent: 12,083,179

Which drugs does patent 12,083,179 protect, and when does it expire?

Patent 12,083,179 protects PLENVU and is included in one NDA.

This patent has ninety-four patent family members in thirty-four countries.

Summary for Patent: 12,083,179

Title:	Colon cleansing compositions and method of use
Abstract:	The invention provides a colon cleansing solution comprising: The invention also provides methods and kits associated with, or making use of the solutions, and compositions for the preparation of the solutions.
Inventor(s):	Lucy Clayton, Alasdair Cockett, Mark Christodoulou, Ian Davidson, Lynn Farrag, Marc Halphen, Leighton Jones, Vanik Petrossian, Peter Stein, David Tisi, Alex Ungar, Jeffrey Worthington
Assignee:	Norgine BV
Application Number:	US17/384,227
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Device;

United States Patent 12,083,179 (PEG/sulfate/salt colon cleansing) claims scope, exclusivity, and US patent landscape

Executive summary: US Patent 12,083,179 is a formulation-and-kit estate built around a specific PEG molecular-weight window (2500–4500 Da), narrow electrolyte/salt ranges (sulfate plus NaCl/KCl), explicit restriction excluding an ascorbate component in “Solution 1,” and a multi-solution kit architecture that pairs the ascorbate-free PEG/sulfate regimen with a second, ascorbate-containing cleansing solution. The independent claim scope is concentrated in the US on a colon-cleansing liquid or admixture form administered in a 400–600 mL final volume, with dependent claims further narrowing to selected salts, sucralose, citric-acid souring (including encapsulated citric), and kit components/ratios for the ascorbate solution. The patent’s enforceable “core” is the ascorbate-free PEG/sulfate/salt composition and its inclusion in kits that include a defined ascorbate-containing second solution.

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What exactly does US 12,083,179 claim for a colon cleansing solution (PEG 2500–4500 Da, sulfates, NaCl/KCl, 400–600 mL)?

Plain-English claim core (Claim 1):
A “colon cleansing solution” defined by five quantitative formulation constraints plus optional flavor/sweetener and a fixed final dosing volume.

Claim 1 numerical guardrails

• PEG concentration: 175 to 220 g/L
• PEG average molecular weight: 2500 to 4500 Da
• Sulfate component: 15 to 20 g/L of one or more alkali metal sulphates and/or alkaline earth metal sulphates
  • Acceptable species are later exemplified (Claim 3): sodium sulphate, potassium sulphate, magnesium sulphate
• Chloride/electrolytes:
  • NaCl: 3.0 to 5.0 g/L
  • KCl: 1.5 to 2.5 g/L
• Final solution volume parameter: solution is 400–600 mL (as a dosing unit in practice)
• Optional: flavoring agents; sweeteners
• Negative limitation (explicit in dependent claims): “substantially free of an ascorbate component” appears in Claim 2 (not in Claim 1 text you provided)

Practical enforceability implication

For infringement analysis in the US, the most litigable points are:

1. PEG MW and concentration window (2500–4500 Da; 175–220 g/L)
2. Total sulfate mass (15–20 g/L) and identity of sulfates
3. Electrolyte balance (NaCl 3–5 g/L; KCl 1.5–2.5 g/L)
4. Unit dosing volume (400–600 mL)
5. Whether an ascorbate component is present at all (because Claim 2 turns on “substantially free”)

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How does Claim 2 (“substantially free of an ascorbate component”) change the infringement map?

Claim 2 adds a key negative ingredient limitation to Claim 1:

• The colon cleansing solution is substantially free of an ascorbate component.

Scope effect

• A product that otherwise matches PEG/sulfate/NaCl/KCl/volume but includes meaningful ascorbate would fall outside Claim 2 (and likely outside Claim 1 if ascorbate is treated as part of “composition” rather than merely an excipient, depending on how “solution comprising” is argued).
• Conversely, a product that is merely neutral, or uses a negligible amount of ascorbate, becomes a factual/technical question tied to the claim term “substantially free.”

Kit logic in the estate

This “asorbate-free Solution 1” limitation is then leveraged structurally in the kit claims (Claims 10–18) by pairing it with a second, explicitly ascorbate-containing Solution 2.

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Which formulation embodiments are explicitly carved in (sulfate selection, sucralose, citric acid and encapsulated citric)?

Claim 3: sulfate identity

• Sulfates selected from sodium sulphate, potassium sulphate and magnesium sulphate (or mixtures).

Scope effect: This reduces enforceability variance if the accused formulation uses only these salts. If an accused product uses other sulfate species (e.g., ammonium sulfate is an out-of-spec candidate under “alkali metal sulphates,” though lithium sulfate would still be an alkali metal sulfate), Claim 3 may not be satisfied, but Claim 1 may still be satisfied as long as it stays within the broader “alkali metal sulphates/alkaline earth metal sulphates” language.

Claim 6: sweetener

• Sweetener is sucralose.

Scope effect: Claim 6 narrows by sweetener identity; the underlying independent formulation still allows optional sweeteners, so sucralose is a dependent fallback.

Claim 5: souring agent

• Souring agent is citric acid or encapsulated citric acid.

Scope effect: This is an additional dependent narrowing parameter that becomes relevant if the accused product differentiates by acidulant type or uses non-citric souring systems.

Claim 4 and Claim 5 combined

• Claim 4 requires: sweetener + further comprises a souring agent
• Claim 5 specifies souring agent type (citric acid / encapsulated citric acid)

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What are the specific “narrow numerical” alternatives (Claim 7, Claim 8, Claim 9)?

Claim 7: exact PEG concentration

• Solution comprises 200 g/L PEG (with PEG MW 2500–4500 Da, as in Claim 1).

Claim 8: exact sulfate range within the window

• Solution comprises 17 to 19 g/L of one or more sulfates (inside Claim 1’s 15–20 g/L band).

Claim 9: a tight quantitative embodiment

This is the strongest “design-around resistance” feature because it states exact representative numbers:

• PEG: 200 g/L, MW 2500–4500 Da
• Sodium sulphate: 18 g/L
• NaCl: 4.0 g/L
• KCl: 2.0 g/L
• Optional flavoring agents; optional sweeteners
• Substantially free of ascorbate (explicit via Claim 2 reference)

Scope effect: Claim 9 operates as a near-“preferred formulation” anchor. If the accused product matches these exact numbers, Claim 9 becomes the easiest path for proving infringement.

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How broad is the kit architecture in Claims 10–18 (two solutions with defined ascorbate logic)?

Claim 10: two-solution kit

A kit comprising:

• First colon cleansing solution: is Claim 2 (PEG + sulfate/NaCl/KCl + substantially free of ascorbate)
• Second colon cleansing solution: is Claim 11 (contains ascorbate and a PEG/electrolyte system)

Claim 11: second solution ascorbate and PEG window

Second solution contains:

• Ascorbate anion: 300 to 800 mmol/L provided by mixture:
  • ascorbic acid (i) and one or more ascorbate salts (ii)
• Molar ratio (ascorbic acid : ascorbate salt): 1:4.5 to 1:7.0
• PEG: 10 to 200 g/L (no narrow MW specified in Claim 11 text you provided, unlike Claim 1)
• Electrolytes: optional
• Sulfates: optional (alkali/alkaline earth sulphates optional)
• Optional flavoring agents; optional sweeteners

Scope effect: Claim 11 makes the “Solution 2” definition largely about ascorbate level and acid/salt ratio.

Claim 12: narrower options within Solution 2

Claim 12 further specifies:

• ascorbate salts include sodium, potassium, magnesium, calcium ascorbate
• ascorbate anion concentration: 300–700 mmol/L
• molar ratio: 1:4.75 to 1:6.75
• “asorbate component” mass and/or component ranges:
  • 60–140 g/L ascorbate component and/or
  • 12–20 g/L ascorbic acid and 80–120 g/L sodium ascorbate

Scope effect: Claim 12 is the tight proof posture if the accused formulation uses those mass and ratio targets.

Claim 13: alternate second solution variant elements

Claim 13 includes at least one of the following:

• essentially free from alkali metal sulphates and alkaline earth metal sulphates
• flavoring agent
• sweetener
• aspartame + orange flavouring
• aspartame at 0.5–4 g/L and orange flavouring at 0.2–1.8 g/L

Scope effect: This is a flavor/sweetener dependent narrowing. It also signals that Solution 2 can be sulfate-free in the referenced embodiments.

Claims 14–18: admixture kit composition and per-kit dosing

• Claim 14: kit includes compositions used for admixture with water to make Solution 1 and Solution 2.
• Claim 15: composition for Solution 1:
  • PEG 100 g (MW 3000–4000 Da)
  • sodium sulphate 9.0 g
  • NaCl 2.0 g + KCl 1.0 g
  • optional flavor/sweetener
  • substantially free of ascorbate component
• Claim 16: composition for Solution 2:
  • ascorbic acid 7.54 g + sodium ascorbate 48.11 g
  • PEG 40 g (MW 3000–4000 Da)
  • NaCl 3.20 g + KCl 1.20 g
  • optional flavor/sweeteners
• Claim 17: combines the compositions in one kit definition
• Claim 18: each composition is provided to be made up in 400–600 mL water

Scope effect: Claims 15–18 convert the abstract Solution 1/Solution 2 into unit-dose admixture sachet-style compositions, making “form-factor” an additional infringement axis. Many generic or competing kits are designed around sachet mass and final make-up volume, so these claims can be highly relevant in practice.

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What does Claim 19 and Claim 20 cover (methods of colon cleansing)?

Claim 19

• A method of cleansing the colon of a subject by administering an effective amount of the colon cleansing solution of Claim 1.

Claim 20

• Similar method, but using the colon cleansing solution of Claim 9.

Scope effect: This is a typical use claim category. If Claim 1 or Claim 9 are infringed by making/selling the solution, the method claim often becomes secondary leverage in enforcement, especially against prescribing/administration in controlled settings.

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How many US patents likely cover this space (PEG-based colon cleansing and electrolytes) versus the specific ascorbate-sparing/kit architecture?

Hard data limitation: You supplied only the claims text for US 12,083,179. Without the patent number’s bibliographic record (filing date, assignee, examiner, priority chain, CPC classes, and citations), it is not possible to produce a complete and accurate US patent landscape for “how many patents cover” this exact formulation theme and kit structure.

What can be stated from claim architecture alone: the estate is structured so that coverage is strongest where a competitor replicates:

• PEG MW range (2500–4500 Da) and concentration (175–220 g/L or the exemplified 200 g/L),
• sulfate mass range (15–20 g/L),
• NaCl/KCl electrolyte balance (3.0–5.0 g/L NaCl and 1.5–2.5 g/L KCl),
• the dosing volume (400–600 mL), and
• the two-solution kit logic separating “Solution 1” as ascorbate-free from “Solution 2” as ascorbate-defined by mmol/L and molar ratios.

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What patents protect this formulation in the US beyond 12,083,179 (continuations, family members, and adjacent claims)?

Hard data limitation: No application number, priority data, patent family list, continuation history, or legal status was provided. Without that record, it is not possible to state which other US patents (continuations/divisionals or family members) exist in the same prosecution and cover adjacent ranges like PEG MW, electrolyte permutations, ascorbate ratio boundaries, sweetener/flavor substitutions, or alternate dosing volumes.

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When does US 12,083,179 lose exclusivity (expiration, PTA, and regulatory exclusivity overlays)?

Hard data limitation: No filing date, priority date, or patent term adjustment (PTA) data was provided, and US market exclusivity depends on the approved NDA/ANDA/BLA or OTC status. Without the bibliographic record, it is not possible to compute the actual expiration or term calendar.

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What is the litigation and Orange Book status of US 12,083,179?

Hard data limitation: The drug product identity tied to this patent (brand name, active ingredients labeling, and FDA listing) and the patent’s Orange Book listing status were not provided. Without that, it is not possible to map Paragraph IV challenges, settlements, or FDA listing/expiration triggers.

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Which generic entry risks exist for a competitor designing around the ascorbate-free Solution 1?

Design-around pressure points implied by the claims:

1. PEG MW range (2500–4500 Da): many PEG grades used in laxatives vary; moving outside this range can avoid Claim 1’s literal scope.
2. PEG concentration (175–220 g/L): formulation mass is often adjustable; moving outside may be a key path.
3. Sulfate mass and identity: change total sulfate load out of 15–20 g/L.
4. NaCl/KCl electrolyte balance: adjust NaCl and KCl outside the specified ranges.
5. Ascorbate-free limitation (Claim 2): adding ascorbate would avoid “substantially free” but may need to then satisfy or conflict with kit-dependent claims.
6. Kit-level ascorbate architecture (Claims 10–18): competitors can attempt single-solution products or alter ascorbate concentration and acid/salt molar ratios.
7. Admixture sachet masses and final make-up volume (Claims 15–18): many infringement analyses in formulations focus on whether the sachet composition, when added to specified volumes, reproduces the claimed mass concentrations.

Risk takeaway: The claims are not merely broad class coverage. They are quantitatively constrained and kit-structured. That increases the feasibility of partial design-arounds but also means that close substitutes are likely to face strong infringement risk if they replicate the same concentration and ratio architecture.

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Key Takeaways

• Independent Claim 1 targets a specific PEG molecular weight (2500–4500 Da) plus tight PEG concentration, sulfate mass, and NaCl/KCl ranges, with a 400–600 mL final make-up volume parameter.
• Claim 2 creates a critical negative limitation: Solution 1 is “substantially free of an ascorbate component.”
• Claims 10–18 define a two-solution kit. The estate differentiates by function: Solution 1 is ascorbate-free, while Solution 2 is defined by ascorbate anion levels (300–800 mmol/L) and ascorbic acid-to-salt molar ratios.
• Claims 9 and 15–18 are the strongest practical embodiments because they provide tight quantitative “anchor” numbers and admixture sachet logic.
• A competitor’s design-around must address multiple simultaneous constraints: PEG MW and concentration, sulfate/electrolyte balance, ascorbate presence or absence, and kit composition ratios.

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FAQs

1. Can a one-solution colon cleansing product infringe the kit claims in US 12,083,179?
2. Which claim is most sensitive to formulation mass: Claim 1 (ranges) or Claim 9 (exact embodiment)?
3. How does using a non-citric souring agent affect dependent claims involving citric acid or encapsulated citric acid?
4. If a product includes small amounts of ascorbate, does “substantially free” still permit infringement risk?
5. What kit design changes most directly reduce risk under the ascorbate mmol/L and molar ratio requirements for Solution 2?

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References (APA)

1. United States Patent 12,083,179. (Claims as provided in user prompt).

Drugs Protected by US Patent 12,083,179

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Salix	PLENVU	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	209381-001	May 4, 2018		RX	Yes	Yes	12,083,179		Y			FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

International Family Members for US Patent 12,083,179

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	092500
Australia	2013314442
Australia	2015228962