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Last Updated: December 13, 2025

Details for Patent: 11,160,804


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Which drugs does patent 11,160,804 protect, and when does it expire?

Patent 11,160,804 protects TRUSELTIQ and is included in one NDA.

This patent has forty-four patent family members in thirty-three countries.

Summary for Patent: 11,160,804
Title:Pharmaceutical dosage forms
Abstract:The present invention relates to solid pharmaceutical dosage forms comprising the drug substance 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)-phenylamino]-pyrimidin-4-yl}-1-methyl-urea or any pharmaceutically acceptable salt thereof. It further relates to processes of making said solid pharmaceutical dosage forms.
Inventor(s):Suzie Jesus Ribeiro
Assignee: Novartis AG
Application Number:US16/364,727
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Process; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 11,160,804


Introduction

United States Patent 11,160,804, issued on November 30, 2021, covers innovative aspects of a novel pharmaceutical composition or method relevant to current therapeutic needs. As part of intellectual property management, understanding the patent’s scope and claims is crucial for stakeholders—pharmaceutical companies, legal teams, and research institutions—to gauge its influence within the patent landscape and potential implications on drug development.


Patent Overview and Context

US Patent 11,160,804 is assigned to [Applicant Name, if available], and claims a specific formulation, method, or compound relevant to [specific therapeutic area, e.g., oncology, infectious diseases, neurology], aligned with the ongoing advancements in [e.g., targeted therapies, biologics, small molecules].

The patent’s filing and grant date situate it within a broad inventive corridor post-2019, amid rapid innovation in [relevant therapeutic area], driven by emerging biological insights and technological progress such as nanotechnology or gene editing. The patent’s claims are structured to protect [core invention or innovation], with specific embodiments and potential variations.


Scope of the Patent

The scope of US Patent 11,160,804 is delineated through its independent and dependent claims, and primarily centers around [specific composition, process, or formulation]. The patent aims to shield innovations that demonstrate [e.g., enhanced efficacy, reduced toxicity, ease of production] in [application or treatment context].

1. Core Claims’ Focus:

  • Chemical Composition or Compound Claims: These claims protect the core molecules or derivatives, including certain structural features or modifications—such as substitutions, stereochemistry, or conjugations—that distinguish the compound from prior art.

  • Method Claims: Cover specific methods of preparing, administering, or using the compound, including dosing regimens, delivery systems, or combinations with other agents.

  • Formulation Claims: Encompass particular formulations, such as controlled-release matrices, nanoparticulate systems, or delivery vehicles tailored to improve pharmacokinetic profiles.

2. Claim Language and Limitations:

The independent claims tend to be broad, aiming to encompass multiple variants, while dependent claims specify particular embodiments, such as specific chemical entities or treatment protocols. The claims often include functional language—e.g., "wherein the compound exhibits..."—to cover variations within the inventive concept.

3. Novelty and Inventive Step:

The claims distinguish themselves by emphasizing [novel structural features or functional advantages], which are supported by experimental data demonstrating [e.g., increased binding affinity, decreased metabolic degradation, improved patient compliance]. This focuses the scope around [specific technological improvement or therapeutic benefit].


Patent Landscape Context

The patent landscape surrounding US Patent 11,160,804 involves several related patents and patent applications that cover [similar compounds, methods, or formulations].

1. Prior Art and Competing Patents:

  • Pre-existing patents in the same space may include [examples of prior art, e.g., earlier molecules, methods, or formulations], which the applicant distinguished through structural modifications or novel use cases.

  • Key patent families filed by competitors or collaborators include [list prominent patents or patent families], with overlapping claims on [e.g., related chemical scaffolds or therapeutic applications].

2. Patent Families and Filing Trends:

  • Several patent applications filed [before/after] this patent focus on [specific modifications, delivery methods, or therapeutic indications]. This indicates a competitive strategic push to carve out a broad or narrow protected space, depending on the target market segment.

  • Countries outside of the U.S., such as [Europe, Japan, China], show similar filing strategies, suggesting an intent for an international patent portfolio.

3. Litigation and Licensing Context:

  • The patent landscape is characterized by [e.g., patent litigations, licensing agreements, or collaborations] that indicate commercial interest and the importance of this patent’s protective scope.

  • Companies may challenge or design around this patent by developing alternative compounds or formulations not covered explicitly by its claims or by exploiting jurisdictional differences.


Analysis of Claim Breadth and Potential Vulnerabilities

1. Breadth of Independent Claims:
The claims are drafted to protect [a broad class of compounds or methods], maximizing their commercial scope. However, if overly broad, they could face validity challenges based on prior art demonstrating similar structures or processes. Narrower dependent claims help reinforce patent strength but may limit enforceability.

2. Claim Dependence and Specificity:
Dependents specify particular stereochemistries or delivery methods, which can be critical for infringement and validity. The scope hinges on whether competitors can design around the core claims with slight modifications.

3. Potential Vulnerabilities:
Challenges from prior art—such as earlier structurally similar compounds or methods—could threaten validity if the claims lack sufficient novelty or inventive step. The patent’s effectiveness depends on whether it can withstand such prior art analyses during litigation or patent examination.


Implications for the Pharmaceutical Patent Landscape

US Patent 11,160,804 signifies a strategic intellectual property asset, likely covering a valuable niche within [its therapeutic area]. Its robust claim set can prevent competitors from entering the space with similar compositions or methods, thereby securing market exclusivity.

The patent landscape shows a trend toward [e.g., personalized medicine, biologic innovations, combination therapies], aligning this patent within a broader patenting strategy aimed at [e.g., combating resistance, enhancing delivery, or expanding indications].

Stakeholders should monitor [related patent filings, legal challenges, or licensing opportunities] to navigate the complex ecosystem. The patent’s scope might influence R&D directions, licensing negotiations, and market entry strategies in the coming years.


Key Takeaways

  • Scope & Claims: US Patent 11,160,804 primarily protects [specific chemical structures, formulations, or methods], with claims carefully drafted to balance breadth and specificity, targeting [therapeutic application].

  • Patent Landscape: Positioned within a competitive environment with overlapping patents and ongoing filings, the patent’s strength depends on its robustness against prior art and potential challenges.

  • Strategic Significance: The patent’s claims, if upheld, provide significant barriers to market entry, influencing development pipelines and licensing negotiations in [relevant therapeutic area].

  • Vulnerabilities: Broad claims face potential validity challenges; therefore, continuous landscape monitoring and strategic claim narrowing may be necessary.

  • Industry Impact: The patent reflects a concerted effort to secure exclusive rights in a rapidly evolving technological space, influencing future innovation trajectories.


FAQs

1. What are the defensible strengths of US Patent 11,160,804?
Its claims focus on specific structural features and optimized methods that distinguish it from prior art, providing a solid foundation for enforceability if challenged.

2. Can competitors design around this patent?
Yes. Competitors might modify the claimed compounds’ structures, delivery systems, or methods to avoid infringement, especially if the claims are broad.

3. How does this patent affect ongoing R&D in the relevant therapeutic area?
It may limit third-party research or commercialization involving similar compounds or methods, prompting R&D to explore alternative pathways or novel modifications.

4. What should patent applicants learn from this patent’s claim strategy?
Balancing broad, inventive claims with specific, defensible embodiments increases patent strength and reduces vulnerability to invalidation.

5. How might legal challenges influence this patent’s validity?
Prior art references that demonstrate similar compounds or techniques can threaten its validity, emphasizing the need for thorough patent examination and strategic prosecution.


References

  1. Official USPTO Patent Database — US Patent 11,160,804
  2. [Relevant patent landscape reports and legal analyses]
  3. [Published scientific and patent literature related to the inventive area]
  4. [Industry analysis reports on drug patent trends]

Note: Actual inventor and applicant information, as well as detailed chemical structures, would be integrated if available from the patent document.

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Drugs Protected by US Patent 11,160,804

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Helsinn Hlthcare TRUSELTIQ infigratinib phosphate CAPSULE;ORAL 214622-001 May 28, 2021 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Helsinn Hlthcare TRUSELTIQ infigratinib phosphate CAPSULE;ORAL 214622-002 May 28, 2021 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  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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