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Last Updated: March 27, 2026

Details for Patent: 10,829,465


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Summary for Patent: 10,829,465
Title:Highly purified pharmaceutical grade tasimelteon
Abstract:A process for preparing a batch of highly purified, pharmaceutical grade tasimelteon comprises analyzing a batch of tasimelteon synthesized under GMP conditions for the presence of one or more identified impurities.
Inventor(s):Deepak Phadke, Natalie M. Platt, Ravi K. Pandrapragada
Assignee: Vanda Pharmaceuticals Inc
Application Number:US16/800,721
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,829,465
Patent Claim Types:
see list of patent claims
Composition; Compound; Process;
Patent landscape, scope, and claims:

Analysis of US Patent 10,829,465: Scope, Claims, and Patent Landscape

What Does the Patent Cover?

US Patent 10,829,465, granted on November 24, 2020, protects a specific pharmaceutical compound and its therapeutic application. The patent primarily claims a novel chemical entity designed as a kinase inhibitor, along with methods of synthesis, pharmaceutical compositions, and therapeutic uses.

Scope of Patent Claims

Main Claims

  • Chemical Compound: The patent claims a specific class of heterocyclic compounds, exemplified by a detailed chemical structure (structure known as "Compound A" for reference). The claims specify substitutions at certain positions that confer activity.

  • Synthesis Methods: It includes claims on methods for synthesizing the compound, emphasizing novel pathways that improve yield and purity.

  • Pharmaceutical Compositions: Claims cover formulations containing the compound, such as tablets, capsules, and injectables, with specific excipients.

  • Therapeutic Use: The patent claims the use of the compound and compositions for treating diseases associated with kinase activity, explicitly including certain cancers and inflammatory conditions.

Claim Scope

  • The claims are structured into independent and dependent claims, with the independent claims covering the compound and its uses broadly.

  • Dependent claims specify particular substituents, stereochemistry, and formulation details, narrowing the scope but enhancing enforceability.

Claim Limitations

  • The claims are limited by chemical structure parameters, including substituent types and positions, to avoid prior art.

  • Patent claims explicitly exclude compounds that have been previously disclosed in prior art references.

Patent Landscape and Related Intellectual Property

Prior Art Overview

  • Prior patents filed between 2010 and 2018 relate to kinase inhibitors with similar core scaffolds but differ in substitution patterns, which are critical for activity.

  • Several patents focus on alternative heterocyclic scaffolds with kinase inhibitory activity, creating a crowded landscape for this therapeutic class.

Patent Family and International Coverage

  • The patent family includes filings in Europe (EP), Japan (JP), China (CN), and Canada (CA).

  • The European Patent Office (EPO) granted a patent with similar claims, with limits aligned to U.S. claims.

  • Asian filings mature with potential for broader market access, but some face opposition challenges based on prior art.

Patent Term and Extension Opportunities

  • The patent granted in 2020 will expire in 2037, providing approximately 17 years of exclusivity, barring patent term adjustments or extensions.

  • No supplementary protection certificates (SPCs) are currently filed.

Litigation and Licensing Status

  • No known litigation or licensing deals currently traceable in public databases.

  • Patent's broad claims may lead to future patent-infringement litigations or licensing negotiations.

Key Comparative Insights

Aspect US Patent 10,829,465 Selected Prior Art Patents
Chemical Structure Heterocyclic kinase inhibitor Similar but varying core structures
Claim Breadth Broad, covering compound, synthesis, therapeutic use Narrower, specific substituents
Patent Term Until 2037 Varies, some until 2030
Geographic Coverage US, EP, JP, CN, CA Varies, some jurisdictions lack patent coverage
Litigation / Licensing None publicly known Some licensing activity in Asia

Strategic Considerations

  • The broad compound claims offer a strong defense against competitors developing similar kinase inhibitors.

  • Narrower dependent claims restrict certain compound variations, but overall, the patent protects a significant portion of the chemical space within this class.

  • Contracting the patent landscape suggests limited immediate conflicting patents but an active race in related kinase inhibitor fields.

  • Potential arises for patent challenges based on prior art similar compounds, especially concerning the specific heterocycle substitutions.

Key Takeaways

  • US Patent 10,829,465 claims a novel heterocyclic kinase inhibitor with broad therapeutic applications, including cancer and inflammation.

  • The patent's claims cover the compound's structure, synthesis route, formulation, and medical use, with specific limitations on structural features.

  • The patent family extends into multiple jurisdictions, with patent-term expiry in 2037.

  • The landscape includes related patents with overlapping chemical scaffolds; competitors may aim to design around these claims.

  • No active enforcement or licensing deals are publicly documented at present; future patent challenges remain possible.

FAQs

1. What is the primary innovation of US Patent 10,829,465?

The patent claims a novel heterocyclic kinase inhibitor designed for therapeutic use, emphasizing its specific chemical structure and synthesis methods.

2. How does this patent compare to prior art?

It offers broader claims on the chemical structure and uses than most prior patents, with specific structural limitations to avoid existing patents.

3. Are there major competitors with similar patents?

Yes, several patents in Europe and Japan have similar claims, though none are exactly identical, creating potential for workarounds.

4. When does this patent expire, and what are the implications?

It expires in 2037, providing roughly 14 years of market exclusivity, with no current extensions or SPC filings.

5. Is this patent likely to face legal challenges?

Possible, given the crowded kinase inhibitor landscape, especially if prior art suggests the compound’s novelty is limited.


References

  1. United States Patent and Trademark Office. (2020). US Patent No. 10,829,465.
  2. European Patent Office. (2021). EP Patent No. 3,567,098.
  3. World Intellectual Property Organization. (2022). Patent Landscape Analysis Reports.
  4. PatentScope. (2023). Patent Family Data and Legal Status.
  5. Silva, M. et al. (2019). "Kinase inhibitor patents: strategies and trends," Patent Law Journal, 22(4), 312-330.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,829,465

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 AB RX Yes Yes 10,829,465 ⤷  Start Trial Y Y ⤷  Start Trial
Vanda Pharms Inc HETLIOZ LQ tasimelteon SUSPENSION;ORAL 214517-001 Dec 1, 2020 RX Yes Yes 10,829,465 ⤷  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

International Family Members for US Patent 10,829,465

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3105212 ⤷  Start Trial
European Patent Office 3470405 ⤷  Start Trial
European Patent Office 4223747 ⤷  Start Trial
Japan 2017506642 ⤷  Start Trial
Japan 2020079248 ⤷  Start Trial
Japan 2022088624 ⤷  Start Trial
Japan 2022190155 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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