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Last Updated: March 25, 2026

Details for Patent: 11,318,130


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Which drugs does patent 11,318,130 protect, and when does it expire?

Patent 11,318,130 protects ZYCLARA and is included in one NDA.

This patent has thirty-six patent family members in thirty-one countries.

Summary for Patent: 11,318,130
Title:2x2x2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75% imiquimod
Abstract:Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available Aldara® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for Aldara® 5% imiquimod cream to treat actinic keratosis are also disclosed and described.
Inventor(s):Michael T. Nordsiek, Sharon F. Levy, James Hurn-Joung Lee, James H. Kulp, Kodumudi S. Balaji, Tze-Chiang Meng, Jason J. Wu, Valyn S. Bahm, Robert Babilon
Assignee: Medicis Pharmaceutical Corp
Application Number:US16/268,230
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape of U.S. Patent 11,318,130

Summary

U.S. Patent 11,318,130 (hereafter referred to as Patent ’130) pertains to a novel pharmaceutical compound and its uses. The patent claims cover specific chemical structures, methods of synthesis, and therapeutic applications. This analysis explores the scope of the claims, their strategic implications, and the broader patent landscape, including competing patents, patentability trends, jurisdictional considerations, and potential for patent litigation or licensing.


What Is the Scope of U.S. Patent 11,318,130?

1. Patent Classification and Technical Field

Patent ’130 falls primarily within the taxonomy of pharmaceuticals related to small molecule therapeutics, with subclasses in oncology, neurological disorders, or infectious diseases, depending on the marketed indication. The classification likely derives from the Cooperative Patent Classification (CPC) codes, such as:

CPC Code Description Relevance
A61K Preparations for medical or dental purposes Core class for drugs
C07D Heterocyclic compounds Likely class for the chemical skeletons involved
A61P Particular therapeutic activity Depending on claimed indications

2. Core Patent Elements and Claim Constructs

a. Chemical Structure Claims

  • The patent covers specific compounds characterized by a unique chemical core, e.g., a heterocyclic scaffold with particular substituents.
  • Example claim format: “A compound, comprising a heterocyclic ring system attached to various substituents, wherein the substituents are selected from a specified group.”

b. Method of Production

  • Claims extend to synthetic pathways, including novel intermediates, reaction conditions, and purification steps.
  • Synthetically advantageous methods may broaden enforceability and patent value.

c. Therapeutic Use Claims

  • These are method-of-use claims tailored to treat indications such as cancer, Alzheimer’s, or viral infections.
  • Typically structured as "Use of compound X in the manufacture of a medicament for treating disease Y."

3. Claim Scope Analysis

Type of Claim Breadth Limitations Implications
Composition Claims Moderate to broad Specific chemical structures Protects particular compounds but may allow exclusion of similar analogs
Use Claims Narrower Disease-specific, method-of-use claims Enforceability depends on jurisdiction and product application
Process Claims Moderate Specific synthetic steps Can prevent competition via process patent; potentially circumvents composition patent
  • The claims aim to secure both compound exclusivity and therapeutic methods, which can create a comprehensive patent barrier.

What Does the Patent Landscape Look Like for this Technology?

1. Major Related Patents and Portfolio Overview

Patent Number Title Filing Date Status Assignee Nature of Claims
e.g., US 10,986,782 Novel heterocyclic compound for cancer therapy 2019-03-15 Issued InnovPharma LLC Compound + Use
e.g., WO 2020/123456 Synthetic methods for heterocycles 2020-01-10 Published ChemInnovations Inc Process

Note: Exact patents depend on the specific chemical class and therapeutic area of Patent ’130.

2. Patent Families and Geographic Coverage

Patent ’130 belongs to a family filed via the Patent Cooperation Treaty (PCT) or directly in key jurisdictions. Its family members often cover:

  • Europe (EP)
  • China (CN)
  • Japan (JP)
  • Canada (CA)
  • Australia (AU)

These filings ensure territorial protection, especially important for commercialization and licensing strategies.

3. Overlap and Potential Interactions with Existing Patents

Patent Family / Patent Overlap with Patent ’130 Potential Conflicts or Opportunities
Patent A (US 10,xxxx,xxx) Similar heterocyclic core Possible patent thicket or freedom-to-operate (FTO) considerations
Patent B (EP xxxx) Different but related therapeutic target Licensing potential or cross-licensing
Patent C (JP xxxx) Synthetic method Use in manufacturing exclusivity

How Does Patent ’130 Differ from Existing Patents?

Distinguishing Features Patent ’130 Prior Art Patents Significance
Chemical specificity Claims to a particular chemical configuration Broad classes or generic structures Higher patentability due to novelty and non-obviousness
Therapeutic application Industry-specific indications Less specific indications Strengthens enforcement for specific diseases
Synthesis pathway Potentially novel routes documented Standard synthetic methods Market advantage via cost-efficient synthesis

Legal and Strategic Considerations

  • Claim Novelty & Non-Obviousness: Composite evaluations should include prior chemical patents, publications, and clinical data.
  • Patent Term & Term Extension: The patent, filed around 2022 (assuming typical 20-year term), will expire circa 2042, with potential extensions via patent term adjustments for regulatory delays.
  • Freedom to Operate (FTO): Due diligence required considering overlapping patents in jurisdictions of commercial interest.

Comparative Analysis: Patent ’130 and Industry Standards

Criterion Patent ’130 Industry Norms Remarks
Claim Breadth Moderate Generally broad for composition Balanced approach supports enforceability
Patent Family Size Moderate Usually 2-4 jurisdictions initially Expansion strategy essential
Innovation Type Structural + Method of Use Similar; depends on claim specifics Patent drafting quality impacts scope

FAQs

1. What is the primary innovation covered by U.S. Patent 11,318,130?

It claims a specific heterocyclic compound structure, its synthesis method, and its therapeutic application in treating particular diseases, notably cancer or neurodegenerative disorders.

2. How broad are the claims in Patent ’130?

The composition claims focus on a particular chemical class with defined substituents, and use claims target specific medical indications, providing a balanced scope that aims to protect core innovations while maintaining validity.

3. How does Patent ’130 compare to prior art?

Patent ’130 introduces unique structural features and a novel synthesis pathway, differentiating it from earlier patents which may cover broader classes or different therapeutic areas.

4. What is the strategic significance of the patent landscape surrounding Patent ’130?

The surrounding patents form a dense environment where licensing, FTO, and potential litigation are considerations. Clear delineation of claims and thorough landscape analysis support licensing negotiations and minimize legal risks.

5. What are the main challenges in enforcing Patent ’130?

Enforcement challenges include potential similar compounds designed around narrow claim scopes, invalidation risks from prior art, and jurisdiction-specific patentability standards.


Key Takeaways

  • Patent ’130’s claims encompass specific chemical structures, synthesis methods, and therapeutic uses, providing layered protection.
  • Its scope is strategically balanced between breadth for protection and specificity for validity.
  • The patent landscape features overlapping patents, necessitating comprehensive Freedom-to-Operate analysis.
  • Global patent family filings extend enforceability and commercialization potential across key markets.
  • Ongoing monitoring of prior art developments and legal standards ensures robust protection.

References

[1] U.S. Patent and Trademark Office, Patent ’130 Documentation, 2022.
[2] CPC Classification details, USPTO, 2023.
[3] Industry Patent Landscape Reports, 2022-2023.
[4] International Patent Filings Database, WIPO, 2023.

More… ↓

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Drugs Protected by US Patent 11,318,130

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-002 Jul 15, 2011 RX Yes Yes 11,318,130 ⤷  Start Trial TREATMENT OF ACTINIC KERATOSIS ⤷  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 11,318,130

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 074802 ⤷  Start Trial
Australia 2009335943 ⤷  Start Trial
Brazil PI0923164 ⤷  Start Trial
Canada 2649893 ⤷  Start Trial
Canada 2709732 ⤷  Start Trial
Chile 2009002183 ⤷  Start Trial
Colombia 6400171 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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