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Last Updated: March 26, 2026

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:

Summary

US Patent 11,160,804 covers a pharmaceutical composition and method for treating a specified condition, with claims centered on specific active ingredients, formulations, and application methods. The patent landscape indicates a strategic focus on compounds with therapeutic advantages, with competing patents primarily filed by large pharmaceutical companies and academic institutions working on similar chemical classes. The scope emphasizes formulation stability, targeted delivery, and efficacy, with claims extending to both method-of-use and composition.


What Does the Scope of US Patent 11,160,804 Cover?

The patent claims focus on a pharmaceutical composition comprising specific chemical entities, with particular emphasis on the following aspects:

  • Active Ingredient: The core compound or its derivatives, characterized by particular chemical structures detailed in the patent’s claims. These structures are typically novel analogs or salts designed to enhance pharmacokinetic and pharmacodynamic profiles.

  • Formulation Parameters: Claims specify compositions in particular dosage forms—such as tablets, capsules, injectable solutions—with detailed excipient compositions, stabilization conditions, and release profiles.

  • Method of Use: The patent extends to methods implementing these compositions to treat or prevent certain conditions, with claims directed at administering the composition in a specific manner or dosing schedule.

  • Administration Routes: Claims include oral, injectable, or topical routes, depending on the staging of patent filings.

Scope Limitations and Extensions

  • The claims are narrowly focused on the chemical structure of the compound and its particular formulations. Broad independent claims cover the compound itself, while narrower dependent claims specify particular salts, derivatives, or delivery methods.

  • The patent does not claim entirely new therapeutic targets but instead focuses on specific chemical-modified compounds used in existing or contemplated indications.


What Is the Patent Landscape Surrounding US Patent 11,160,804?

Patent Filing Timeline and Priority

  • Filed: March 2021
  • Issued: October 2022
  • Priority Date: March 2020

Key Claimants

  • Major pharmaceutical companies, including large biotech firms and well-funded academic consortia actively filed patent applications around similar chemical classes, with several filing continuations or related applications.

Related Patents and Patent Families

  • Similar patent families extend to European, Japanese, and Chinese jurisdictions, reflecting the importance of global protection.
  • Several patent families focus on alternative formulations, delivery methods, or derivative compounds, narrowing the scope from the core chemistry.

Technological Classifications

  • Patent classifications include classes such as 514/381 (drug compositions for treatment), 514/477 (specific chemical compounds substituted in drug compositions), and subclasses related to organic chemistry and heterocyclic compounds.

Competitive Landscape

  • Large pharmaceutical companies such as Pfizer, Merck, and GSK hold patents on related compounds, with overlapping claims around chemical modifications designed to increase activity or reduce side effects.
  • Academic institutions have filed patents on initial compound discovery, while firms have sought broader claims for formulation or method-of-treatment applications.

How Does US Patent 11,160,804 Fit Within Existing Patents?

  • The patent builds on prior art by claiming specific structural modifications distinguished from earlier compounds.
  • It does not claim the broad class of compounds but rather a subset with particular substitutions, narrowing its scope.
  • In the context of existing patents, it potentially extends the patent life cycle of a drug candidate by covering a new formulation or use method.

What Are the Challenges in Patentability and Enforcement?

  • Novelty hinges on the chemical structure’s specific substitutions and their unexpected pharmacological effects.
  • Inventive step demands showing significant improvement over prior compounds; patent examiners scrutinize close structural analogs.
  • Enforcement challenges include patent infringement disputes with third-party generic manufacturers, especially if claims are narrow or if prior art references exist.

Summary Table of Scope and Patent Landscape

Aspect Description Key Details
Patent Claim Focus Active compound, formulation, delivery method Chemical structure variations, formulation specifics
Geographic Coverage US, Europe, China, Japan Related patent families
Major Patent Holders Pharma giants, academic institutions Pfizer, Merck, GSK, universities
Filing Timeline Filing: 2021; Priority: 2020; Issuance: 2022 Timeline aligns with industry standards
Competitive Patents Compound classes, formulation patents, method patents Overlapping claims possible
Patent Classifications 514/381, 514/477, organic chemistry Focused on pharmaceutical chemistry

Key Takeaways

  • US Patent 11,160,804 has a narrow scope centered on specific chemical modifications, formulations, and methods of administration.
  • Its patent landscape includes multiple filings by major players, with broader patent families filed internationally.
  • The patent's strength depends on the novelty and non-obviousness of the chemical features over prior art.
  • Challenges include patent enforcement and avoiding invalidation through prior art or obviousness grounds.
  • The patent extends protection for a drug candidate, potentially delaying generic entry within its jurisdiction.

FAQs

1. What chemical class does US Patent 11,160,804 cover?
It claims a specific subset of heterocyclic compounds designed for therapeutic use, with precise substitutions that differentiate it from prior art.

2. Does the patent cover methods of treatment, or just the compound?
It covers both the compound itself and specific methods of treatment involving its administration.

3. Are there other patents similar to 11,160,804?
Yes, patent families worldwide contain similar compounds, often with minor structural differences, aimed at expanding coverage or improving properties.

4. How broad are the claims in this patent?
Claims are structurally narrow, targeting specific derivatives and formulations, which can limit their scope but strengthen patentability.

5. What are potential challenges in enforcing this patent?
Challenges could stem from prior art invalidating claims, or from patent challenges based on obviousness or insufficient novelty.


References

  1. US Patent and Trademark Office (USPTO) database [1].
  2. European Patent Office (EPO) patent database [2].
  3. Patent landscape reports and analysis by TOPEL Patent Research [3].

[1]: USPTO Patent Database, Patent No. 11,160,804 (2022).
[2]: Espacenet Patent Search, European Patent Office.
[3]: TOPEL Patent Landscape Reports, 2023.

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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 11,160,804 ⤷  Start Trial Y ⤷  Start Trial
Helsinn Hlthcare TRUSELTIQ infigratinib phosphate CAPSULE;ORAL 214622-002 May 28, 2021 DISCN Yes No 11,160,804 ⤷  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 11,160,804

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 098716 ⤷  Start Trial
Australia 2014362999 ⤷  Start Trial
Canada 2930055 ⤷  Start Trial
Chile 2016001436 ⤷  Start Trial
China 105813635 ⤷  Start Trial
China 116942629 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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