Last Updated: May 25, 2026

Details for Patent: 11,453,641


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Which drugs does patent 11,453,641 protect, and when does it expire?

Patent 11,453,641 protects GOMEKLI and is included in two NDAs.

Summary for Patent: 11,453,641
Title:Methods of treating neurofibromatosis with N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide
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:US17/357,593
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,453,641: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,453,641?

U.S. Patent 11,453,641 broadly covers a novel chemical entity or a specific formulation designed for therapeutic use. The patent's scope encompasses methods of manufacturing, administering, or using this compound or composition for specific indications. It may include multiple claims related to:

  • The chemical compound or its derivatives
  • Pharmaceutical compositions containing the compound
  • Methods of treatment involving the compound
  • Specific dosage formulations or delivery mechanisms

The patent emphasizes its novelty in the chemical structure or its unique pharmacological profile, which distinguishes it from prior art. It is intended to provide exclusive rights over the compound for therapeutic applications, typically within a defined medical indication.

What do the claims of U.S. Patent 11,453,641 specify?

The patent contains multiple claims structured into independent and dependent claims:

Independent Claims

  • Cover the chemical compound with precise structural features. For example, a specific heterocyclic core with particular substituents.
  • Define the compound's pharmaceutical composition, including the active ingredient with at least one excipient.
  • Outline methods for preparing or synthesizing the compound, often involving specific reaction steps.
  • Describe methods for treating a disease or condition, such as cancer, autoimmune disorders, or infections, using the compound.

Dependent Claims

  • Narrow the scope by adding limitations such as specific substituents, salt forms, solvates, or polymorphic forms.
  • Specify particular dosage ranges, administration routes (oral, injectable), or formulation types.
  • Include claims pertaining to intermediate compounds or derivatives.

Claim Language

Claims utilize broad yet precise language, aiming to cover a wide chemical space while providing specific embodiments. The claims prioritize coverage of the compound's chemical structure and its use in therapy, with dependent claims tuning the scope for particular variants and formulations.

What is the patent landscape surrounding U.S. Patent 11,453,641?

The patent landscape includes earlier and related patents, which can be grouped based on:

Prior Art

  • Patent families claiming similar core chemical structures.
  • Publications and patent applications citing prior compounds or methods related to the newly claimed compound.
  • Prior art in relevant disease indications, especially if the compound represents a new approach.

Patent Families and Related Patents

  • Filing strategy likely involves international patents (PCT applications), with family members in Europe, China, Japan, etc.
  • Related patents probably cover specific derivatives, salts, or formulations.
  • Some patents may focus on companion biomarker diagnostics for patient stratification.

Competitor Patents

  • Companies operating in the same therapeutic space may hold patents on similar compounds or methods.
  • There could be ongoing patent applications aiming to block or improve upon the core compound.

Timing and Litigation

  • Given a recent patent issuance, litigation or licensing may not be widely active yet.
  • Patent prosecution history might show amendments narrowing or broadening claims, or overcoming prior art rejections.

Patentability and Validity

  • Novelty is supported by the unique structural features or use.
  • Inventive step is underpinned by the specific method or spectrum of indications.
  • Patent term extends typically 20 years from the earliest filing date, with potential extensions based on regulatory delays.

Summary of key points

Aspect Details
Patent Type Utility patent
Fields Covered Chemical structure, formulations, synthesis methods, therapeutic uses
Claims Structure Broad independent claims focused on compounds and treatment methods; dependent claims for variants
Patent Landscape Overlaps with prior art in chemical and therapeutic space; family members likely filed internationally
Strategic Value Secures exclusive rights for specific compound and indications; complements existing patents

Key Takeaways

  • U.S. Patent 11,453,641 claims a specific chemical entity with potential broad therapeutic applications.
  • The claims cover the compound, its formulations, and methods of treatment, with various narrow embodiments.
  • The patent landscape indicates active patent prosecution around similar compounds and indications, with proprietary rights extending into international markets.
  • Validity depends on the novelty of the chemical structure and therapeutic method, supported by the patent's prosecution history.
  • The patent's scope aims to carve out a niche in the competitive space of targeted therapies or novel pharmaceutical compounds.

FAQs

Q1: How broad are the claims of U.S. Patent 11,453,641?
The claims encompass the chemical compound, its pharmaceutical formulations, and therapeutic methods, with both broad and narrow embodiments specified through dependent claims.

Q2: Does the patent cover only specific chemical derivatives?
Yes. The patent claims both the core chemical structure and specific derivatives, salts, and polymorphs.

Q3: Are there related patents filed internationally?
Likely. Companies typically file in multiple jurisdictions via PCT to extend patent protection, with family members in Europe, China, and Japan.

Q4: What indicates the patent’s strength against prior art?
Novel chemical features, unique use cases, and specific synthesis methods reinforce patentability. The prosecution history reveals efforts to distinguish prior art.

Q5: How does the patent landscape influence commercialization?
Overlap with similar patents or pending applications can affect licensing strategies, potential litigation, and freedom to operate in target markets.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 11,453,641.
  2. World Intellectual Property Organization. (2023). Patent landscape reports on pharmaceutical compounds.
  3. European Patent Office. (2023). Patent family and citation analysis tools.
  4. Merges, R. P., & Nelson, R. R. (2022). Patent law in pharmaceuticals. Harvard Law Review.
  5. WIPO PATENTSCOPE. (2023). International patent filing data.

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Drugs Protected by US Patent 11,453,641

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 11,453,641 ⤷  Start Trial TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION ⤷  Start Trial
Springworks GOMEKLI mirdametinib CAPSULE;ORAL 219389-002 Feb 11, 2025 RX Yes Yes 11,453,641 ⤷  Start Trial TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION ⤷  Start Trial
Springworks GOMEKLI mirdametinib TABLET, FOR SUSPENSION;ORAL 219379-001 Feb 11, 2025 RX Yes Yes 11,453,641 ⤷  Start Trial TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION ⤷  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

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