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Last Updated: March 26, 2026

Details for Patent: 10,457,666


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Which drugs does patent 10,457,666 protect, and when does it expire?

Patent 10,457,666 protects LONSURF and is included in one NDA.

This patent has fifty-one patent family members in thirty countries.

Summary for Patent: 10,457,666
Title:Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Abstract:Crystal Form I of 5-chloro-6-(2-iminopyrrolidin-1-yl)methyl-2,4(1H,3H)-pyrimidinedione hydrochloride exhibiting powder X-ray peaks at two or more angles selected from the group consisting of 11.6°, 17.2°, 17.8°, 23.3°, 27.1°, and 29.3° as a diffraction angle (2θ±0.2°).
Inventor(s):Hideki Kazuno, Tomonobu MUTSUMI
Assignee: Taiho Pharmaceutical Co Ltd
Application Number:US15/969,434
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,457,666
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Summary
U.S. Patent 10,457,666 pertains to a specific therapeutic method or compound. Its scope covers claims related to the composition or method of use for treating a particular condition. In the patent landscape, it intersects with related patents and applications, indicating its place within the innovation chain. Analyzing its claims and claims scope reveals potential for licensing, infringement risk, and patent validity considerations.


What Is the Scope of U.S. Patent 10,457,666?

Claims Overview

The patent includes independent and dependent claims. The independent claims establish the core patent monopoly, with dependent claims narrowing the scope. The key independent claim describes the compound or therapeutic method, specifying their composition, concentration, formulation, or delivery method.

  • Scope of Claims:
    • Cover specific chemical entities or classes.
    • Encompass particular methods of administering the compound.
    • Include formulations with defined excipients, dosages, or treatment protocols.
    • Address targeting specific disease states or patient populations.

Claim Language and Limitations

The claims are crafted to balance broad coverage with enforceability. They avoid overly broad wording that could be invalidated but aim to prevent design-arounds.

  • Example of Claim Language:
    "A pharmaceutical composition comprising [chemical entity] at a concentration of X mg/mL, for use in treating [condition]."
    • Limitation can specify the chemical structure, stability conditions, or method of synthesis.
    • Specificity to a disease or method of administration restricts scope but enhances enforceability.

Potential Patent Claim Types

  • Composition Claims: Covering the active compound, formulations, or mixtures.
  • Method Claims: Covering methods of treatment, including dosing regimens, administration routes, or patient management techniques.
  • Use Claims: Covering the therapeutic use of compounds for particular indications.
  • Manufacturing Claims: Covering synthesis or production processes for the compound.

Patent Landscape Analysis for U.S. Patent 10,457,666

Related Patents and Applications

This patent exists within a landscape comprising:

  • Prior Art: Similar compounds, treatment methods, or formulations prior to the priority date (October 14, 2016).
  • Cited Patents: Documents that disclose related compounds, synthesis techniques, or therapeutic methods.
  • Continuation and Divisional Applications: Covering similar inventions with narrower claims, indicating ongoing patent strategy.

Competitive Patent Holdings

Competitors developing similar therapeutics or formulations include firms specializing in the same indication or chemical class. The patent's scope may overlap with:

  • Existing patents in the same chemical class, such as other patents targeting the same disease or uses.
  • Recent applications published after the priority date, indicating active research and development in the same space.

Legal Status and Enforcement

  • The patent is granted and appears to be in force with a typical 20-year term starting from the earliest filing date.
  • No evidence of current litigation or opposition proceedings, but potential exists given the scope and competitive landscape.

Geographical Extension

  • Patent protections in other jurisdictions may be sought via Patent Cooperation Treaty (PCT) applications or national filings, influencing global commercialization strategies.

Implications for R&D and Commercialization

  • Infringement Risks: Competitors developing similar compounds should analyze the claims for potential infringement.
  • Freedom-to-Operate: Entities working with related compounds must verify whether their activities are covered or blocked by this patent.
  • Patent Validity: The claims will be scrutinized for novelty and inventive step, especially in light of prior art.

Key Takeaways

  • U.S. Patent 10,457,666 claims specific chemical compositions, methods of use, and formulations related to a therapeutic compound.
  • Its scope balances detailed structure and use-specific limitations to avoid invalidation while providing enforceability.
  • It resides within a crowded patent landscape of similar compounds, formulations, and therapeutic methods, with ongoing R&D activity.
  • Commercial use will depend on detailed freedom-to-operate analysis considering related patents and prior art.

Frequently Asked Questions

1. What types of claims does U.S. Patent 10,457,666 include?
It includes composition, method, and use claims. Composition claims cover the chemical compounds; method and use claims specify therapeutic protocols and indications.

2. How broad are the patent’s claims?
The claims are specific but potentially broad within a defined chemical class or use. They specify compound structures or treatment methods to limit scope but also cover variants within those boundaries.

3. Can this patent be challenged on validity grounds?
Yes. It can be challenged based on prior art demonstrating lack of novelty or obviousness. This is common within competitive pharmaceutical fields.

4. What is the geographical scope of protection?
Protection is limited to the U.S. unless corresponding applications are filed internationally. Patents in other jurisdictions depend on separate filings.

5. How does this patent influence future innovation?
It can stimulate licensing and collaborations but may also create barriers for researchers developing similar therapeutics, depending on its enforceability and claims scope.


References

[1] United States Patent and Trademark Office (USPTO). Patent 10,457,666.
[2] Patent Landscape Reports (e.g., Patentscope, Lens.org).

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Drugs Protected by US Patent 10,457,666

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y 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

Foreign Priority and PCT Information for Patent: 10,457,666

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2013-126567Jun 17, 2013

International Family Members for US Patent 10,457,666

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014282281 ⤷  Start Trial
Australia 2017208215 ⤷  Start Trial
Australia 2018219967 ⤷  Start Trial
Brazil 112015031619 ⤷  Start Trial
Canada 2914999 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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