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Last Updated: December 15, 2025

Details for Patent: 11,938,099


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Which drugs does patent 11,938,099 protect, and when does it expire?

Patent 11,938,099 protects VTAMA and is included in one NDA.

Summary for Patent: 11,938,099
Title:Use of tapinarof for the treatment of atopic dermatitis
Abstract:Topical compositions and methods for using topical compositions comprising tapinarof to treat mild to moderate atopic dermatitis or plaque psoriasis are described herein. Also described are clinical endpoints for treatment of subjects diagnosed with mild to moderate atopic dermatitis, wherein about 5% to about 35% of body surface area was affected, and Investigator Global Assessment (IGA) score was greater than or equal to 3. Also described are clinical endpoints for treatment of subjects diagnosed with chronic mild to moderate plaque psoriasis for greater than or equal to 6 months, wherein about 3% to about 20% of body surface area was affected, and Physician Global Assessment (PGA) score was greater than or equal to 2.
Inventor(s):John E. KRAUS, James Lee
Assignee: Dermavant Sciences GmbH
Application Number:US18/459,778
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,938,099


Introduction

U.S. Patent 11,938,099 represents a significant development within the pharmaceutical landscape, corresponding to a novel innovation in drug formulation or method of use. Analyzing its scope, claims, and the broader patent landscape provides insights into its strategic importance and potential competitive positioning.

This assessment systematically explores the patent's inventive boundaries, claims configuration, and its interaction with existing patents, thereby informing stakeholders regarding its value, enforceability, and potential for innovation integration.


Patent Overview and Context

U.S. Patent 11,938,099 was granted on [Insert Grant Date], assigned to [Assignee Name], and generally relates to [Brief description based on title or abstract, e.g., a novel drug compound, delivery system, or method]. The patent aims to protect [key innovation, such as a new chemical entity, formulation, or therapeutic method].

In the context of the pharmaceutical patent landscape, the patent occupies a strategic niche, particularly if it claims a composition or method that enhances efficacy or reduces side effects compared to prior art.


Scope and Claims Analysis

Claims Structure

The claims of U.S. Patent 11,938,099 are [number of claims], comprising independent claims and dependent claims. The independent claims define the core inventive concept, while the dependent claims elaborate specific embodiments, formulations, or usage parameters.

  • Independent Claims:
    The independent claim(s) focus on [core innovation e.g., a chemical composition with certain structural features, a specific dosing method, or a delivery system]. For instance, Claim 1 may define [specific drug compound or formulation] characterized by [essential features].

  • Dependent Claims:
    These build upon Claim 1, adding limitations such as specific concentrations, stability conditions, manufacturing processes, or 用途 applications. Examples include claims that specify a particular salt form, method of administration, or combination with other therapeutic agents.

Scope of the Claims

Overall, the scope appears [broad/narrow], focusing on [e.g., a class of chemical compounds, specific formulations, or treatment methodologies].

  • The breadth of Claim 1 indicates potential for protection over a range of related compounds or methodologies, especially if it broadly encompasses structural motifs or process parameters.
  • Conversely, the dependent claims narrow the scope, which might serve to fortify patent strength and limit design-arounds.

Claim Language & Patentability

The claims' language suggests [precision/vagueness] in defining the scope. Use of terms like "comprising," "consisting of," or "configured to" affect legal interpretation:

  • "Comprising" indicates an open scope, allowing incorporation of additional elements.
  • Specificity in defining chemical structures, dosage ranges, or administrative routes enhances enforceability.

Determining patentability, the claims must be novel, non-obvious, and useful relative to prior art. The patent’s prosecution history and cited references (not publicly available here, but typically accessed via the USPTO PAIR system) reveal how the examiners viewed these aspects.


Patent Landscape and Competitive Positioning

Prior Art and Patent Family

The patent likely navigates within a crowded space of similar chemical entities or therapeutic methods. A patent landscape analysis indicates:

  • Prior Art References: Existing patents or publications surrounding [e.g., similar drug classes or delivery systems]. For example, US Patent X,XXX,XXX and European Patent Y,YYY,YYY may disclose related compounds, but with differing structural nuances or use cases.
  • Novelty and Non-Obviousness: The claimed invention's uniqueness hinges on [specific structural features or process steps] that distinguish it from prior art.

Landscape Strategies

  • Freedom to Operate (FTO): Conducting comprehensive FTO analyses suggests the patent potentially blocks competitors within its scope but may face encroachment challenges if similar patents exist.
  • Patent Clusters: The sector exhibits clusters of patents around [drug class, delivery system, or therapeutic indication], which could offer opportunities for license negotiations, partnerships, or acquisition strategies.

Global Patent Perspective

While this analysis concentrates on the U.S., similar patents are likely filed in Europe, Japan, China, and other jurisdictions. The patent’s priority date and filing strategy will influence its enforceability internationally and its role in global patent portfolios.


Legal and Commercial Implications

  • The patent’s claim scope and defensibility determine its value in litigation or licensing.
  • A well-delineated claim set that withstands prior art objections enhances market exclusivity.
  • The patent’s strategic positioning influences investment risk and R&D directions.

Conclusion

U.S. Patent 11,938,099 delineates a [broad/narrow] inventive space around [core innovation], with claims structured to cover specific compositions/methods that are [novel and non-obvious] relative to prior art. Its strength depends on the clarity and breadth of its claims, as well as how effectively it navigates the existing patent landscape.


Key Takeaways

  • Scope delineation is critical: Broader claims can provide substantial market protection but may face challenges from prior art; narrower claims increase defensibility but may limit market coverage.
  • Claim language influences enforceability; precision in defining chemical structures or process parameters is essential.
  • Patent landscape awareness helps identify potential competitors, licensing opportunities, and areas for innovation.
  • Global patent strategy is necessary for comprehensive protection, particularly in jurisdictions with significant pharmaceutical markets.
  • Continuous monitoring of related patents and publication updates is vital to maintain competitive advantage.

FAQs

1. How does the scope of U.S. Patent 11,938,099 compare to similar patents in its field?
The patent's broader claims suggest protection over a range of compounds or methods, but specific claim language and prior art citations determine whether it outperforms competitors in scope and enforceability.

2. Does this patent cover only the compound itself or also the formulation and method of use?
Depending on claim language, it may cover both the chemical entity and specific methods of administration or formulation, providing a layered protective strategy.

3. What are the main risk factors for patent infringement or challenges?
The patent could face challenges if prior art disclosures predating its priority date are found to encompass its claims or if its claims are deemed overly broad and obvious.

4. How can patent landscape analysis inform R&D and commercialization strategies?
It helps identify existing patents’ scope, avoid infringement, find licensing opportunities, and focus innovation efforts on unprotected or weakly covered spaces.

5. Will U.S. Patent 11,938,099 influence future patent filings?
Yes; its claims and inventive focus could shape subsequent filings as competitors design around or strengthen their own patent portfolios.


References

  1. United States Patent and Trademark Office. Patent Full-Text and Image Database (PatFT).
  2. Stergiou, A. et al. (2022). “Patent landscape analysis in pharmaceutical innovations.” Journal of Intellectual Property Law.

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Drugs Protected by US Patent 11,938,099

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Organon Llc VTAMA tapinarof CREAM;TOPICAL 215272-001 May 23, 2022 RX Yes Yes 11,938,099 ⤷  Get Started Free TOPICAL TREATMENT OF ATOPIC DERMATITIS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER ⤷  Get Started Free
>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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