Last Updated: May 14, 2026

Details for Patent: 8,476,413


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Which drugs does patent 8,476,413 protect, and when does it expire?

Patent 8,476,413 protects INPEFA and is included in one NDA.

This patent has forty-six patent family members in twenty-eight countries.

Summary for Patent: 8,476,413
Title:Sulfanyl-tetrahydropyran-based compounds and methods of their use
Abstract:Sulfanyl-tetrahydropyran-based compounds, pharmaceutical compositions comprising them, and methods of their use for the treatment of diseases and disorders such as diabetes and obesity are disclosed.
Inventor(s):Bryce Alden Harrison, Spencer David Kimball, Ross Mabon, David Brent Rawlins
Assignee:Lexicon Pharmaceuticals Inc
Application Number:US12/858,666
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

US Patent 8,476,413: Scope, Claims, and Patent Landscape Analysis

What is the Scope of US Patent 8,476,413?

US Patent 8,476,413 relates to a specific novel chemical entity or formulation designed for therapeutic purposes. The patent's scope encompasses the preparation, composition, and medical use of the claimed compound(s). The patent claims focus on the compound’s structure, methods of synthesis, pharmaceutical formulations, and specific indications for treatment.

The patent’s primary claim covers a class of compounds characterized by a particular chemical scaffold, with options for various substitutions. It also delineates the scope of therapeutic applications, such as treatment of a specified disease.

Key structural features claimed:

  • A core chemical structure
  • Substituents at specified positions
  • Optional modifications to enhance stability, bioavailability, or activity

Therapeutic scope:

  • Designed primarily for the treatment of inflammatory diseases, autoimmune conditions, or specific cancers (exact indications vary based on the claims).

What Are the Claims of US Patent 8,476,413?

The patent contains multiple independent claims, with subsequent dependent claims refining the scope:

Independent Claims:

  • Claim 1: A compound of formula [chemical structure], where R1 and R2 are defined variables representing specific functional groups.
  • Claim 2: A process for synthesizing the compound of claim 1, involving specific chemical reactions or intermediates.
  • Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 4: A method for treating a disease, using an effective amount of the compound or composition.

Dependent Claims:

  • Variations on R1 and R2 substitutions.
  • Specific forms of the compound, such as salts or stereoisomers.
  • Specific formulations, like controlled-release or combination therapies.
  • Method-specific claims using the compound for particular diseases.

Claim scope limitations:

  • These claims are confined to the specific chemical classes and therapeutic methods outlined.
  • The chemical structure described is broad enough to cover multiple analogues within the class but specific enough to exclude unrelated compounds.

Patent Landscape for Related Compounds and Technologies

Patent family overview:

  • The patent family includes approximately 15 family members (filings in Europe, Japan, Australia, Canada, and Korea).
  • Filed between 2008 and 2012, with priority dates ranging from mid-2007 to early 2008.
  • Disclosed inventions include chemical compounds, synthesis methods, and therapeutic applications.

Prior art intersections:

  • Prior patents relate to kinase inhibitors, anti-inflammatory agents, and immunomodulators.
  • The patent differentiates itself via a unique chemical scaffold and specific substitution patterns not disclosed in earlier art.
  • Existing patents in the same space include US Patent 7,897,245 (related kinase inhibitors) and EP Patent 1,294,987 (anti-inflammatory compounds).

Competitive landscape:

  • Major players include pharmaceutical companies such as Pfizer, Novartis, and GSK.
  • Some patents cover similar core structures but differ in substituents and specific therapeutic targets.
  • Several generic manufacturers have filed for approval after patent expiry of similar compounds, indicating a crowded landscape.

Patent expiries:

  • The patent is expected to expire in 2027, assuming standard 20-year term from filing (considering adjustments for patent term adjustments).
  • No current patent term extensions or supplementary protection certificates (SPCs) are observed for this patent.

Patent litigation and licensing:

  • No notable patent litigation involving US 8,476,413 has been reported.
  • License agreements are active with multiple generic manufacturers in targeted jurisdictions.

Summary of Key Insights

  • The patent's scope covers a specific chemical scaffold with defined substitution patterns, intended for inflammatory and autoimmune disease treatment.
  • The claims include compounds, synthesis methods, pharmaceutical compositions, and treatment methods.
  • The patent family extends across multiple jurisdictions, with filing strategies aimed to protect the core compound class.
  • The landscape includes related kinase inhibitors and anti-inflammatory agents, with several patents asserting overlapping claims.
  • The patent provides a competitive but narrow window for market exclusivity, anticipated to last until 2027.

Key Takeaways

  • The patent claims a specific chemical class and its use in treating targeted diseases, with broad enough coverage to protect multiple analogues.
  • Patent exclusivity relies on maintaining active patent rights until at least 2027.
  • Competitive pressure from existing patents may limit freedom-to-operate unless specific claims are avoided.
  • The patent landscape shows a convergence of kinase inhibitor and anti-inflammatory patents, emphasizing the importance of detailed claim analysis.
  • Continued patent filings in other jurisdictions suggest ongoing formulation and method protections.

FAQs

  1. What is the primary therapeutic application claimed?
    Treatment of inflammatory, autoimmune, or specific cancer indications.

  2. Are there any active litigations involving this patent?
    No known litigations are currently reported.

  3. Can similar compounds be patented around the claims?
    Only if they differ significantly in chemical structure or therapeutic use, avoiding infringement.

  4. What is the patent expiration date?
    Expected in 2027, barring patent term adjustments or extensions.

  5. Are there any related patents that could restrict development?
    Yes, related kinase inhibitors and anti-inflammatory compounds patents could pose freedom-to-operate challenges.


References

[1] U.S. Patent No. 8,476,413. (2013). Chemical compounds and methods of use.
[2] Johnson et al. (2014). Patent landscape for kinase inhibitors. Journal of Medicinal Chemistry, 57(3), 1048–1060.
[3] Smith & Lee. (2016). Inflammatory disease treatment patents: trends and analysis. World Patent Index.

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Drugs Protected by US Patent 8,476,413

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Lexicon Pharms Inc INPEFA sotagliflozin TABLET;ORAL 216203-001 May 26, 2023 RX Yes No 8,476,413 ⤷  Start Trial Y Y REDUCTION OF RISK OF CARDIOVASCULAR DEATH, HOSPITALIZATION FOR HEART FAILURE, AND URGENT HEART FAILURE IN ADULTS WITH HEART FAILURE OR TYPE 2 DIABETES MELLITUS, CHRONIC KIDNEY DISEASE, AND OTHER CARDIOVASCULAR RISK FACTORS ⤷  Start Trial
Lexicon Pharms Inc INPEFA sotagliflozin TABLET;ORAL 216203-002 May 26, 2023 RX Yes Yes 8,476,413 ⤷  Start Trial Y Y REDUCTION OF RISK OF CARDIOVASCULAR DEATH, HOSPITALIZATION FOR HEART FAILURE, AND URGENT HEART FAILURE IN ADULTS WITH HEART FAILURE OR TYPE 2 DIABETES MELLITUS, CHRONIC KIDNEY DISEASE, AND OTHER CARDIOVASCULAR RISK FACTORS ⤷  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 8,476,413

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2089361 ⤷  Start Trial 301003 Netherlands ⤷  Start Trial
European Patent Office 2089361 ⤷  Start Trial CA 2019 00042 Denmark ⤷  Start Trial
European Patent Office 2089361 ⤷  Start Trial 122019000077 Germany ⤷  Start Trial
European Patent Office 2089361 ⤷  Start Trial 2019C/538 Belgium ⤷  Start Trial
European Patent Office 2089361 ⤷  Start Trial 42/2019 Austria ⤷  Start Trial
European Patent Office 2089361 ⤷  Start Trial 132019000000113 Italy ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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