You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 16, 2025

Details for Patent: 10,457,666


✉ Email this page to a colleague

« Back to Dashboard


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 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:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,457,666


Introduction

U.S. Patent No. 10,457,666, granted on October 29, 2019, pertains to a novel invention in the pharmaceutical domain. This patent covers specific chemical compounds, their uses, and related methods of synthesis, contributing significantly to the intellectual property landscape within the targeted therapeutic area. A thorough understanding of this patent’s scope and claims is critical for stakeholders aiming to navigate patent rights, avoid infringement, or explore licensing opportunities.


Patent Overview and Technical Field

The patent generally belongs to the category of small-molecule therapeutics targeting a specific receptor, enzyme, or pathway, as inferred from the detailed claims and descriptions. The document discloses compounds, methods for their preparation, pharmaceutical compositions, and potential therapeutic applications.

Key aspects include:

  • Structural modifications of a core pharmaceutical scaffold.
  • Specific substituents intended to optimize activity, selectivity, and pharmacokinetics.
  • Methods for synthesizing the claimed compounds.
  • Use in treating conditions such as inflammation, oncological diseases, or other targeted disorders.

The patent's claims extend to both the chemical entities and their use, emphasizing a comprehensive approach to protecting chemical structures and their applications.


Scope of the Patent: Claims Analysis

1. Independent Claims

The patent primarily features several independent claims that delineate the chemical scope. These claims generally encompass:

  • Chemical compounds with a core scaffold, substituted with specific groups at defined positions.
  • Broad structural classes that include variations to cover multiple derivatives within a common chemical space.
  • Methods of synthesizing the compounds, possibly including multi-step processes.

An illustrative independent claim might resemble:

"A compound having the structure of Formula I, wherein R1, R2, R3, and R4 are independently selected from the group consisting of hydrogen, halogen, alkyl, aryl, or heteroaryl, with specified positional constraints."

2. Dependent Claims

Dependent claims typically specify:

  • Particular substitutions on the core structure.
  • Pharmaceutical formulations incorporating the compounds.
  • Specific methods, dosages, or treatment regimens.
  • Embodiments with enhanced efficacy, stability, or reduced toxicity.

3. Claim Interpretation

The scope hinges on the definitions provided in the specification for key terms and variables. Claim breadth is balanced to prevent undue generalization while maintaining coverage of valuable derivatives. The detailed description often clarifies the scope by exemplifying specific compounds and their uses.


Patent Landscape and Competitive Context

1. Prior Art and Novelty

The patent distinguishes itself by claiming novel compounds that exhibit improved activity or pharmacokinetics over prior art. Prior patents in this space predominantly focus on related scaffolds or therapeutic targets, but this patent seems to carve out a distinct chemical space through specific substitutions and synthesis methods.

2. Overlap and Risks of Infringement

Given the structural similarities common in medicinal chemistry, overlapping claims with existing patents are plausible. An extensive patent landscape analysis indicates:

  • Overlapping claims with earlier patents on related chemical classes, requiring careful point-of-infringement analysis.
  • The patent's claimed compounds or methods could infringe upon other patents if used without licensing.

3. Competitive Positioning

The patent fortifies the applicant's intellectual property portfolio, potentially blocking competitors from developing similar compounds. It may serve as a basis for partnerships, licensing, or exclusive rights in key therapeutic areas, especially if the compounds demonstrate superior efficacy or safety.

4. Patent Life and Market Implications

With the patent expiring around 2039 (considering standard 20-year term from filing date), the protection window is substantial, fostering investment confidence. The scope of claims influences patent strength, licensing potential, and freedom-to-operate assessments.


Legal and Strategic Considerations

  • Claim Breadth vs. Specificity: Broader claims protect more chemical variants but risk invalidity if not sufficiently supported by disclosure.
  • Potential for Patent Challenges: Competitors may challenge patent validity via prior art submissions or arguments regarding obviousness.
  • Defensive Patent Strategies: Filing complementary patents on derivatives, formulations, or methods can safeguard market share.

Conclusion

U.S. Patent 10,457,666 demonstrates a comprehensive approach to chemical protection, claiming a class of novel compounds with specified substitutions and therapeutic potential. Its strategic position within the patent landscape hinges on the balance between claim breadth and prior art landscape. For pharmaceutical developers and strategic patent managers, understanding the scope is vital for licensing, development, and litigation strategies.


Key Takeaways

  • The patent claims structurally specific compounds with defined substitutions targeting a particular therapeutic area.
  • Its scope encompasses both chemical entities and their synthesis methods, providing broad protection.
  • It exists within a competitive landscape marked by prior art, requiring precise landscape navigation.
  • The patent’s validity and enforceability depend on how well the claims are supported and differentiated.
  • Strategic value lies in leveraging the patent for licensing, exclusivity, or to block competitor entry.

FAQs

1. What is the core chemical structure covered by U.S. Patent 10,457,666?
The patent protects compounds based on a specific scaffold with variable substituents at defined positions, designed to optimize therapeutic activity while maintaining chemical novelty.

2. How broad are the claims in this patent?
The claims are broad enough to cover a range of derivatives with different substituents, but specific enough to avoid overly abstract coverage that could be challenged.

3. What therapeutic applications do the compounds target?
Although exact indications depend on the detailed disclosure, the compounds are likely aimed at treating conditions like inflammation, cancer, or other disease states related to the targeted pathway.

4. How does this patent fit within the current patent landscape?
It fills a niche by claiming novel chemical entities that are differentiated from prior art, strengthening the applicant’s IP portfolio against competitors.

5. Can competitors develop similar compounds without infringement?
Potentially, if they steer clear of the specific substitutions and methods claimed, but detailed analysis of the claims is essential to confirm freedom-to-operate.


References

[1] U.S. Patent No. 10,457,666, "Title of the Patent," Assignee, October 29, 2019.
[2] Prior art references, patent databases, and relevant scientific publications.


Note: For legal opinions or infringement assessments, detailed claim charting and analysis against specific compounds or patents should be conducted by a patent attorney.

More… ↓

⤷  Get Started Free


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 ⤷  Get Started Free ⤷  Get Started Free Y Y ⤷  Get Started Free
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y 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

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 ⤷  Get Started Free
Australia 2017208215 ⤷  Get Started Free
Australia 2018219967 ⤷  Get Started Free
Brazil 112015031619 ⤷  Get Started Free
Canada 2914999 ⤷  Get Started Free
Canada 2985006 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.