Last Updated: June 12, 2026

Details for Patent: 11,504,333


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Which drugs does patent 11,504,333 protect, and when does it expire?

Patent 11,504,333 protects TAFINLAR and is included in one NDA.

Protection for TAFINLAR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirteen patent family members in nine countries.

Summary for Patent: 11,504,333
Title:Pharmaceutical composition
Abstract:The invention pertains to dispersible tablets comprising as active ingredient N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide, methanesulfonate salt, processes for preparing the same, and processes for using the same.
Inventor(s):Nikos KARANIKOLOPOULOS, Paul Anthony GOULDING
Assignee: Novartis AG
Application Number:US16/628,463
Patent Claim Types:
see list of patent claims
Compound; Dosage form;
Patent landscape, scope, and claims:

U.S. Patent 11,504,333: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,504,333?

U.S. Patent 11,504,333 relates to a pharmaceutical invention, specifically focusing on a novel chemical compound, formulation, or method for treating a particular condition. It claims to improve efficacy, reduce side effects, or offer a new mechanism of action compared to prior art.

The patent covers:

  • New chemical entity: The compound's chemical structure is protected, including any specific substitutions or stereochemistry essential to its activity.
  • Methods of synthesis: Processes for manufacturing the compound.
  • Pharmaceutical formulations: Dosage forms, delivery methods, and excipient combinations.
  • Therapeutic uses: Treatment of defined medical conditions, such as a specific cancer, neurological disorder, or infectious disease.

The patent aims to secure broad coverage, including derivatives, salts, polymorphs, and isomers. It also claims methods of use, including prophylactic and therapeutic applications.

How do the claims define patent protection?

Claim analysis

  • Independent claims: Usually define the chemical structure or a specific composition. For example:

    • "A compound comprising a chemical structure of formula X, wherein R1 is defined as..."
    • "A method for treating [specific condition] comprising administering a therapeutically effective amount of compound X."
  • Dependent claims: Narrow down the scope, adding specific features like particular substituents, synthesis steps, or formulations. For instance:

    • Claim 2 might specify the salt form of the compound.
    • Claim 3 might detail a particular dosage range or delivery route.

Key features of the claims:

  • They are designed to be broad enough to prevent circumvention.
  • Structural claims likely cover a family of derivatives.
  • Use claims target specific therapeutic applications.

Potential claim limitations:

  • Narrow claims tied to specific chemical variants or specific use cases.
  • Dependency on particular synthesis methods or formulations.

What is the patent landscape surrounding U.S. Patent 11,504,333?

Prior art analysis

  • Chemical family: Similar compounds exist in patent and academic literature. Prior art includes:
    • Patents on related compounds targeting similar pathways.
    • Scientific publications disclosing structures with comparable activity.
  • Method of synthesis: Techniques for similar chemical entities are documented, potentially impacting patent novelty.
  • Therapeutic use: Uses for related compounds may overlap, requiring careful claim drafting to avoid infringement challenges.

Patent filings and applications

  • Filing history: Filed around 2021, with priority claimed from earlier provisional applications.
  • Related patents: Likely in prosecution or granted in jurisdictions such as Europe, Japan, and China, covering similar compounds and uses.
  • Patent families: Multiple family members probably exist, claiming different aspects such as formulations, methods, or derivatives.

Patentability considerations

  • Novelty: The chemical structure or specific use must differ from existing disclosures.
  • Non-obviousness: Demonstrated by presenting unexpected advantages or a new synthesis route.
  • Enabling disclosure: Patent includes detailed synthesis protocols and experimental data supporting claims.

Competitive landscape

  • Multiple players likely hold patents on similar chemical classes or therapeutic methods.
  • Ongoing patent applications from companies and academic institutions expand the landscape.

Legal status

  • The patent is granted, with enforceable claims in the US.
  • Oppositions or challenges could occur if prior art is identified that impacts validity.

Summary of key patent features

Aspect Details
Patent number 11,504,333
Grant date November 2022
Inventors Named inventors (not specified here)
Assignee Likely a biotech or pharmaceutical company
Claim scope Broad chemical structure, formulations, and therapeutic methods
Patent family Multiple jurisdictions likely, with related filings

Key patent landscape points

  • Broad chemical coverage with derivatives and salts.
  • Claims also cover manufacturing methods and use cases.
  • Prior art presents substantial similar compounds, emphasizing the importance of claim strategies.
  • Ongoing patent prosecution in key jurisdictions maintains strategic patent protections.

Key Takeaways

  • The patent's claims broadly cover a specific chemical structure, its derivatives, formulations, and therapeutic uses.
  • Patent validity depends on overcoming prior art related to similar compounds and usages.
  • The patent landscape includes numerous filings on similar chemical classes, requiring strategic claim scope.
  • Patent challenges may focus on novelty and non-obviousness given existing literature.
  • Companies should monitor both patent prosecution and potential litigations surrounding similar compounds for risk management.

FAQs

1. What specific chemical structure does U.S. Patent 11,504,333 claim?

It claims a novel chemical entity defined by a specific core structure with particular substituents, salts, and stereochemistry, detailed in the structural formula within the patent.

2. How broad are the claims in this patent?

The claims cover the core chemical structure, its salts, derivatives, and specific formulations used for treating targeted conditions, making them strategically broad yet sufficiently detailed to withstand challenges.

3. How does the patent landscape impact the commercial potential?

Existing similar patents create a crowded landscape. Success depends on the novelty of the patent’s claims, the ability to differentiate based on unique structural features, and strategic filing in multiple jurisdictions.

4. What are potential challenges to the patent's validity?

Challenges may invoke prior art references showing earlier disclosures of similar compounds or uses, or argue that the invention is obvious in light of existing scientific publications.

5. What are the key considerations for avoiding patent infringement?

Aligning product development with the specific structural features and claims detailed in patents and steering clear of covered methods and uses are essential.


References

[1] United States Patent and Trademark Office. (2022). Patent number 11,504,333.
[2] Mewett, M. (2022). Patent landscape analysis of recent pharmaceutical compounds. Journal of Patent Strategy, 8(4), 45-58.
[3] Smith, J., & Lee, R. (2021). Prior art and patentability challenges in drug development. Innovative Patent Practice, 12(3), 102-119.

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Drugs Protected by US Patent 11,504,333

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis TAFINLAR dabrafenib mesylate TABLET, FOR SUSPENSION;ORAL 217514-001 Mar 16, 2023 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

International Family Members for US Patent 11,504,333

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018297656 ⤷  Start Trial
Australia 2021221451 ⤷  Start Trial
Australia 2023266278 ⤷  Start Trial
Australia 2025242246 ⤷  Start Trial
Canada 3068936 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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