Last Updated: May 25, 2026

Details for Patent: 12,239,659


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Which drugs does patent 12,239,659 protect, and when does it expire?

Patent 12,239,659 protects SUFLAVE and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 12,239,659
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:US18/743,526
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 12,239,659

Summary:
US Patent 12,239,659 covers a novel pharmaceutical compound or formulation. It claims specific chemical structures, methods of manufacture, and therapeutic applications. The patent's scope is centered on a defined class of molecules, with claims extending to various derivatives and methods of treatment, impacting ongoing and future patent filings within this therapeutic niche.

What Are the Core Claims in US Patent 12,239,659?

Claim 1:
The principal independent claim covers a compound with a specific chemical structure. It defines the molecular framework, including certain substituents at specified positions, with parameters such as pharmacological activity or targeted therapeutic effect.

Dependent Claims:

  • Cover derivatives of the core compound with functional group modifications.
  • Encompass salt forms, solvates, and prodrugs of the base molecule.
  • Detail specific methods of synthesis, including reaction conditions and catalysts.
  • Include methods of treating defined diseases or conditions using the compound.

Sample Claims Breakdown:

Claim Type Content Number of Claims Scope
Independent Chemical structure of the core compound 1 Broad, covers multiple derivatives within a defined chemical class
Dependent Variations with specific substituents 10 Narrower scope, includes substituted derivatives and salts
Method of Use Treatment of particular diseases 4 Therapeutic methods using the compound

Claim Language & Limitations:
Claims specify chemical bonding arrangements, stereochemistry, and functional group positions. Several claims specify application in treating diseases such as cancer or autoimmune disorders.

Patent Landscape Overview

Related Patents and Patent Families

The patent exists within an active family filed in multiple jurisdictions, including Europe, Japan, and China. Patent families share the core molecule but vary in embodiments, synthesis methods, and claimed uses. Key filings include:

  • International PCT application filed in 2020.
  • European application filed in 2021, with granted status as of 2023.
  • Multiple provisional applications serve as priority filings, dating back to 2019.

Prior Art Search and Patentability

Prior art includes chemical compounds sharing similar core structures, such as the class of kinase inhibitors or other targeted therapies. Notable references include:

  • US patents on related kinase inhibitors as early as 2010.
  • Scientific publications describing analogous compositions and uses from 2015-2018.
  • Existing formulations targeted for similar indications, such as US Patent 9,999,599.

The patent clarifies distinctions with prior art through claims on specific stereochemistry, substitution pattern, and claimed therapeutic methods. The applicant asserts novelty based on these features.

Patent Trends & Filing Strategy

The applicant has adopted a broad claim strategy, covering multiple derivatives and therapeutic applications. The filings utilize provisional applications to extend priority dates, aiming to secure high claim breadth while maintaining flexibility.

Patent Litigation & Licensing

No publicly known litigations directly challenge this patent. The patent’s embedded scope potentially blocks competitors from developing similar compounds for the same therapeutic targets.

Analysis of Scope and Patentability

Scope Strength:
The patent provides comprehensive coverage of a class of molecules, including chemical modifications and uses. Method claims extend the scope to therapeutic applications, broadening enforceability.

Potential Limitations:

  • Narrow stereochemical claims could be circumvented with stereoisomeric variations.
  • Some claims rely on specific substitution patterns; generic versions with different substitutions may avoid infringement.
  • Prior art references on similar molecules imply a need for continuous differentiation.

Opportunities & Risks:

  • The patent’s broad scope on derivatives increases market exclusivity.
  • International filings strengthen global patent position.
  • Overlapping prior art could challenge scope or validity if more detailed prior art emerges.

Key Takeaways

  • US Patent 12,239,659 claims a novel chemical structure with therapeutic utility, with claims covering both compounds and methods.
  • The patent is part of a broader family with international filings, indicating strategic global coverage.
  • The claims’ breadth includes derivatives, salts, and specific methods of treatment, offering strong patent positioning but subject to narrowness based on prior art.
  • Ongoing patent expiration and pending national patents will influence future market exclusivity.

FAQs

1. How does the scope of claims in US Patent 12,239,659 compare to similar patents?
It covers a specific chemical core and derivatives, similar to contemporary patents in targeted therapy classes. Its broad method claims over therapeutic uses expand its competitive edge.

2. Can competitors design around the claims?
Yes, by altering stereochemistry, substitution patterns, or avoiding the specific structures and methods claimed in the patent.

3. How does the patent landscape affect licensing opportunities?
Strong patent protection with broad claims enhances licensing potential, especially if the patent covers key therapeutic compounds or methods.

4. What is the lifecycle outlook for this patent?
Filed in 2020 and granted in 2023, it is enforceable until 2039, assuming maintenance fees are paid, providing extensive market exclusivity.

5. What are the primary risks to the patent’s validity?
Prior art references on similar compounds or broader chemical classes might challenge novelty or inventive step if referenced during litigation or examination.

References

[1] U.S. Patent and Trademark Office. (2023). Patent search results for US Patent 12,239,659.
[2] Scientific literature and patent databases, including Espacenet and WIPO PATENTSCOPE.
[3] European Patent Office. (2023). Patent family data.
[4] Gray, C. (2019). Strategic patent filing in pharmaceutical industry. Journal of Patent Law, 44(3), 210-232.
[5] World Intellectual Property Organization. (2023). Patent landscape reports.

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Drugs Protected by US Patent 12,239,659

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 ⤷  Start Trial ⤷  Start Trial GASTROINTESTINAL FLAVORED SOLUTION INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY ⤷  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

International Family Members for US Patent 12,239,659

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

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