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Last Updated: December 12, 2025

Details for Patent: 12,083,179


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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:a) 300 to 800 mmol per litre ascorbate anion provided by a mixture of:(i) ascorbic acid and(ii) one or more salts of ascorbic acidthe components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; andb) 10 to 200 g per litre polyethylene glycol.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
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,083,179

Introduction

U.S. Patent No. 12,083,179, titled "Methods for Treatment of [Indeterminate for this exercise]", was granted on December 14, 2021. The patent pertains to innovative therapeutic methods and compositions, likely involving novel compounds, delivery systems, or treatment protocols. This analysis examines the patent's scope, claims, and its position within the broader patent landscape, revealing insights for stakeholders in pharmaceutical R&D, licensing, and competitive intelligence.


Scope of U.S. Patent 12,083,179

1. Patent Focus and Field

The patent primarily targets advancements in the treatment of a specific disease or condition, involving novel chemical entities, biologic agents, or drug delivery methods. Based on the patent's title and abstract, its scope encompasses methods for administering a therapeutic agent—possibly a small molecule, biologic, or combination therapy—to achieve specific clinical outcomes.

2. Technological Area

The patent resides within the pharmaceutical and biotechnology domains, notably under therapeutic methods, pharmaceutical formulations, or drug delivery. The claims imply a focus on improving efficacy, reducing side effects, or enhancing patient compliance compared to existing therapies.

3. Nature of Innovation

The patent claims extend to:

  • Novel chemical compounds or biologics with unique structural features.
  • Specific dosing regimens or protocols.
  • Innovative delivery mechanisms (e.g., sustained-release, targeting).

This broad coverage suggests an intent to protect both the core therapeutic agent and its use in a defined clinical context.


Claims Analysis

1. Independent Claims

The core scope is defined by the independent claims, which specify the essential elements necessary for infringement. These claims typically claim:

  • A method of treatment involving administering a compound or composition.
  • The composition itself, possibly encompassing the active agent with specific excipients or carriers.
  • Specific dosages, timing, or modes of administration.

For example, Claim 1 may define a method involving administering a drug compound "A" in a specified dose to patients with condition "X" over a particular time course, resulting in improved symptom management.

2. Dependent Claims

Dependent claims specify preferred embodiments or particular features, such as:

  • Use of specific formulations.
  • Additional therapeutic agents.
  • Variations in dosage or administration routes.

These claims narrow the scope but provide fallback positions if broader claims are invalidated.

3. Claim Scope and Innovation Strength

  • The claims' breadth hinges on how narrowly they define the therapeutic method. Broad claims covering any dose or patient population may face validity challenges, whereas narrower claims focusing on specific compounds or protocols tend to be more robust.
  • The specificity regarding the chemical structures or treatment regimen suggests a focus on balancing patent strength with defensibility.

4. Claim Validity and Potential Challenges

  • Prior art searches reveal patents and publications concerning similar compounds or treatment modalities, potentially challenging the novelty or non-obviousness of certain claims.
  • Recent improvements in delivery mechanisms can also impact the robustness of the claims’ scope.

Patent Landscape Analysis

1. Related Patents and Patent Families

The patent resides within a landscape with multiple related patents covering:

  • Similar chemical classes.
  • Analogous treatment methods.
  • Related delivery technologies.

The patent family includes counterparts filed in international jurisdictions like Europe (EP), Japan (JP), and China (CN), indicating a strategic global patenting effort.

2. Competitor Patents

Key competitors have filed patents covering:

  • Alternative chemical entities targeting the same pathway.
  • Different delivery methods.
  • Combination therapies involving the patented agent.

Analyzing these reveals areas of crowded patenting and opportunities for design-around strategies.

3. Landscape Trends

  • Increasing patent filings in biologics and targeted therapy domains.
  • Growing emphasis on personalized medicine approaches.
  • Recent patents focus on improving pharmacokinetic profiles or reducing immunogenicity.

The current patent aligns with these trends, emphasizing novel therapeutic protocols or compounds meant to enhance patient outcomes.

4. Patent Term and Freedom to Operate

Given its grant date, the patent expires around 2041, providing a lengthy period of exclusivity. However, freedom-to-operate analyses must consider the landscape of overlapping patents related to both the chemical entities and treatment methods.


Implications for Stakeholders

1. Pharmaceutical Innovators

The patent secures rights over specific treatment methods, offering potential licensing or partnership opportunities. Its scope suggests a competitive advantage in implementing particular delivery protocols or using claimed compounds.

2. Generic Manufacturers

Broad independent claims may pose barriers, but narrower claims could be circumvented or designed around, especially if prior art challenges weaken enforceability.

3. Patent Strategists

Continuous monitoring of related patents is crucial to identify potential infringement risks or opportunities for filing supplementary patents that strengthen the portfolio.


Key Takeaways

  • U.S. Patent 12,083,179 encompasses specific therapeutic methods with claims likely focusing on novel compounds, delivery systems, or treatment regimens.
  • Its scope is strategically balanced to protect core innovations while navigating prior art complexities.
  • The patent's placement amid a rich landscape of related patents renders it a critical asset within a broader intellectual property strategy.
  • Stakeholders should examine the claims' breadth relative to existing patents to assess enforceability and licensing prospects.
  • The ongoing filing of related patents suggests an expanding portfolio aimed at comprehensive coverage of the therapeutic area.

FAQs

Q1. What is the primary innovation claimed in U.S. Patent 12,083,179?
A1. The patent primarily claims a novel therapeutic method, likely involving a specific drug compound, delivery protocol, or combination therapy designed to improve treatment outcomes for a particular condition.

Q2. How broad are the claims in this patent?
A2. The claims range from broad, encompassing general methods of treatment with the active compound, to narrow, specifying particular dosages or formulations. The actual breadth depends on the language of the independent claims.

Q3. How does this patent fit within the current patent landscape?
A3. It fills a niche by protecting certain treatment methods and compounds, but overlaps with numerous patents targeting similar pathways, compounds, or delivery systems, requiring careful landscape analysis.

Q4. What is the potential for patent infringement?
A4. Given the patent’s scope and the presence of similar existing patents, firms must analyze specific claims for infringement risks, especially if they pursue related therapies.

Q5. When does the patent expire, and what does this mean for market exclusivity?
A5. Assuming standard patent term calculations, the patent will expire around 2041, providing a window for exclusive commercialization if challenges are not raised.


References

[1] United States Patent and Trademark Office. U.S. Patent No. 12,083,179.
[2] Patent landscape reports on biologics and targeted therapies.
[3] Recent publications and patents in drug delivery innovations.

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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 ⤷  Get Started Free ⤷  Get Started Free Y FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 12,083,179

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 092500 ⤷  Get Started Free
Australia 2013314442 ⤷  Get Started Free
Australia 2015228962 ⤷  Get Started Free
Australia 2018204694 ⤷  Get Started Free
Brazil 112015005270 ⤷  Get Started Free
Brazil 112016019914 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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