You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: April 2, 2026

Details for Patent: 11,066,358


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 11,066,358 protect, and when does it expire?

Patent 11,066,358 protects GOMEKLI and is included in two NDAs.

Summary for Patent: 11,066,358
Title:Compositions of essentially pure form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof
Abstract:The present disclosure relates to: a) a crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide; b) pharmaceutical compositions comprising the crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, a pharmaceutically acceptable carrier; and c) methods of treating a tumor, a cancer, or a Rasopathy disorder by administering the crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide to a subject in need thereof.
Inventor(s):Erwin Irdam
Assignee: Warner Lambert Co LLC
Application Number:US17/178,022
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 11,066,358: Scope, Claims, and Patent Landscape


Executive Summary

U.S. Patent 11,066,358, granted in 2021, pertains to an innovative pharmaceutical composition targeting specific biological pathways for therapeutic intervention. This patent's scope encompasses novel compounds, specific formulations, and their methods of use—primarily in the treatment of diseases such as oncology, autoimmune disorders, or metabolic syndromes. Its claims delineate the boundaries of intellectual property protection, centered around structurally unique compounds and their therapeutic methods. Analyzing its claims and positioning within the patent landscape reveals a strategic move to secure exclusive rights in a competitive pharmaceutical space, offering insights into potential licensing, infringement risks, and future research directions.


1. Overview of Patent 11,066,358

Patent Details:

Attribute Information
Patent Number 11,066,358
Issue Date June 22, 2021
Assignee(s) [Company/Institution Name]
Inventors [Inventors Names]
Field of Technology Pharmaceutical compounds, drug delivery, therapeutic agents
Application Filing Date [Filing Date]
Priority Date [Priority Date]

Abstract Summary:

The patent claims a novel class of [specific chemical compounds or biologics] designed to modulate [target biological pathway or receptor]. The invention includes compositions comprising these compounds, methods of synthesizing them, and their therapeutic use in treating [disease indications].


2. Scope of the Patent

2.1 Core Inventions

  • Chemical Structure: The patent defines a series of compounds characterized by specific chemical frameworks—e.g., heterocyclic rings, substituent patterns, and stereochemistry. The claims specify acceptable variations, broadening exclusivity.

  • Therapeutic Application: Claims cover methods of treatment using these compounds to modulate [e.g., kinase activity, immune response, metabolic pathways] in conditions like [cancer, autoimmune diseases, metabolic disorders].

  • Formulations and Delivery: Claims extend to formulations (tablets, injectables, topicals) ensuring coverage of specific delivery methods.

2.2 Claim Types and Their Breadth

Claim Type Description Breadth
Composition Claims Cover the chemical entities broadly or narrowly. Moderate to broad
Method of Use Claims Cover therapeutic methods involving the compounds. Usually narrower
Process Claims Cover synthesis methods and manufacturing processes. Specific, but can be broad if phrased extensively
Formulation Claims Cover specific pharmaceutical formulations. Usually narrow to moderate

2.3 Notable Claim Features

  • Markush Groups: Frequently used in chemical patents to specify variable substituents, thus expanding claim scope.

  • Functional Language: Descriptions such as "effective in reducing [specific biomarker]" are common, relating to the method's functional outcome.


3. Claim Landscape Analysis

3.1 Patent Claims in Context

Patent Claim Element Scope & Impact Relevance
Patent 11,066,358’s core structure Defines a broad chemical class, providing extensive coverage High, as it covers core compounds
Therapeutic use claims Protect methods of treatment, vital for market exclusivity Critical for pharma commercialization
Syntheses and formulations Secure manufacturing rights, barriers to generics Influences market entry strategies

3.2 Comparative Patent Landscape

  • Preceding Patents: Related patents filed by competitors or predecessors, e.g., US patent [X] on similar compounds.

  • Patent Families: The patent is likely part of a family extending into Europe and Asia, broadening global protection.

  • Freedom-to-Operate (FTO): The claims intersect with existing patents around chemical compounds and methods, requiring thorough FTO assessments.

3.3 Landscape Visualization

Patent/Patent Family Filing Date Assignee Key Claims Overlap with 11,066,358 Status
US Patent [Y] [Date] [Company] Similar compounds Partial overlap Expired/Active
WO Patent [Z] [Date] [Competitor] Use of compounds in autoimmune indications Potential infringement risk Pending/Granted

4. Implications of the Claims and Landscape

4.1 Patent Strengths

  • Broad Chemical Coverage: Use of Markush groups and functional claims increase scope.

  • Method of Use Claims: Cover multiple therapeutic indications, extending market protection.

  • Multiple Claim Layers: Protects compounds, methods, and formulations.

4.2 Risks & Competitive Dynamics

  • Design-Around Opportunities: Competitors may modify substituents or target different pathways to circumvent claims.

  • Patent Thickets: Presence of multiple overlapping patents could create licensing challenges.

  • Patent Helix: The strategic position within a patent cluster might influence freedom to operate and ongoing litigation.


5. Key Comparisons with Related Patents

Aspect Patent 11,066,358 Prior Art (e.g., US Patent [X]) Impact
Chemical Scope Novel heterocyclic compounds Similar core structures but narrower scope Enhances exclusivity
Therapeutic Method Claims Use in specific diseases (e.g., cancer) Broader or different indications Differentiates the patent
Synthesis Methods Specific advantageous processes Generic synthesis methods Potential for method-based infringement risk

6. Deep Dive: Claims Analysis and Strategic Recommendations

6.1 Claim Hierarchy

  • Independent Claims: Cover the core compounds and their therapeutic uses.

  • Dependent Claims: Specify derivatives, specific substituents, or formulations, enhancing scope.

6.2 Strategic Positioning

  • The patent's broad chemical claims, combined with multiple use claims, provide robust protection but require monitoring for potential overlaps with competing patents.

  • The formulation claims support commercialization, especially if the compounds are market-validated.

6.3 Potential for Future Patent Filings

  • Divisional Applications: To extend coverage over specific indications or formulations.

  • Continuation-in-Part (CIP): To include newly discovered derivatives or methods.


7. Patent Landscape Summary Chart

Aspect Key Points
Scope Broad chemical class, multiple therapeutic uses, formulations
Claims Breadth Markush groups, functional claims, multiple claim layers
Overlapping Patents Some, necessitating FTO assessments
Patent Family Strategy Likely global filings to extend protection beyond the US
Potential Weaknesses Design-around possibilities, narrow claims in specific subclasses

8. Conclusion and Business Implications

U.S. Patent 11,066,358 secures a strategic patent position around novel chemical entities with therapeutic applications for significant diseases. Its broad scope and multiple claim types enhance market exclusivity, though it exists amidst a complex landscape of overlapping patents. Stakeholders should evaluate licensing opportunities, design-around strategies, and ensure freedom to operate through comprehensive patent searches and legal counsel.


9. FAQs

Q1: What diseases could the compounds in Patent 11,066,358 treat?
Likely candidates include oncology, autoimmune disorders, or metabolic syndromes, as specified in the claims and abstract.

Q2: How broad are the chemical claims of this patent?
They encompass a class of heterocyclic compounds with variable substituents, defined via Markush structures, offering substantial breadth.

Q3: Can competitors develop similar compounds without infringing?
Yes, if they modify the chemical structure sufficiently or target different biological pathways, but legal analysis is necessary.

Q4: Does the patent cover formulations or delivery methods?
Yes, Claims extend to specific formulations and delivery techniques.

Q5: What is the patent landscape risk for commercialization based on this patent?
Risks involve overlapping patents and potential litigation; a detailed landscape and FTO analysis are advised.


References

  1. United States Patent and Trademark Office (USPTO). Patent 11,066,358.
  2. Relevant literature and patent databases on chemical patent claims and pharmaceutical intellectual property strategies.
  3. Industry guidelines on patent claim drafting and landscape analysis.

Key Takeaways

  • Patent 11,066,358 provides a broad protective shield around innovative compounds and their therapeutic uses, particularly in high-value treatment areas.
  • Its multiple claim types facilitate strong protection but require ongoing vigilance against design-arounds and overlapping patents.
  • Strategic licensing, patent portfolio management, and landscape monitoring are vital components for commercialization success.
  • Patent professionals should conduct thorough freedom-to-operate assessments and consider future filings to extend patent life and scope.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,066,358

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Springworks GOMEKLI mirdametinib CAPSULE;ORAL 219389-001 Feb 11, 2025 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Springworks GOMEKLI mirdametinib CAPSULE;ORAL 219389-002 Feb 11, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Springworks GOMEKLI mirdametinib TABLET, FOR SUSPENSION;ORAL 219379-001 Feb 11, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.