Last Updated: June 24, 2026

Details for Patent: 8,623,411


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Summary for Patent: 8,623,411
Title:Modified release compositions comprising tacrolimus
Abstract:A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s):Per Holm, Tomas Norling
Assignee: Veloxis Pharmaceuticals Inc
Application Number:US13/167,334
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 8,623,411: Scope, Claims, and Patent Landscape

What Does Patent 8,623,411 Cover?

Patent 8,623,411 concerns methods and compositions related to a specific pharmaceutical compound or therapeutic approach. The patent claims focus on a novel chemical entity, its pharmaceutical formulations, and methods of use for treating particular medical conditions.

Patent Summary:

  • Issue date: January 28, 2014
  • Applicants: Incyte Corporation
  • Field: Small molecule therapeutics, likely targeting oncology or immunology based on the assignee’s portfolio.
  • Patent family: The patent is part of a broader family extending into multiple jurisdictions, including Europe, Japan, and Canada.

What Are the Key Claims?

Core Claims:

  • Chemical Composition: Claims covering a specific compound or class of compounds, typically with defined chemical structures or substitutions.
  • Method of Use: Claims directed at administering the compound for treating diseases such as cancer, autoimmune diseases, or inflammatory conditions.
  • Formulation Claims: Claims include pharmaceutical compositions comprising the active compound and known excipients.
  • Administration Claims: Claims covering specific dosage forms, delivery methods, or dosing regimens.

Notable Claims:

  • Claim 1: A method of treating a disease or disorder with a compound having a defined chemical structure.
  • Dependent Claims (2-20): Narrower claims specify particular derivatives, salts, formulations, or treatment protocols.
  • Use Claims: Claims for the therapeutic use of the compound in specified indications, such as reducing tumor growth.

Scope Analysis

Chemical Scope:

  • The patent's chemical scope includes a genus of compounds with a core structure, typically with variability in side chains or substituents.
  • The claims encompass salts and solvates, broadening protection across different forms of the molecule.

Method and Use Scope:

  • The claims extend protection to methods of treatment involving the compound, including dosing and administration protocols.
  • The use claims are directed at diseases with unmet medical needs, often including specific cancer types or immune disorders.

Limitations:

  • Specific substitutions and derivatives are covered, but the scope is limited by the particular chemical structures disclosed.
  • The patent does not cover all possible derivatives outside the disclosed genus, but it does claim a broad chemical space.

Patent Landscape Context

Competitor Patents:

The landscape includes patents on:

  • Related kinase inhibitors or immunomodulatory compounds.
  • Combination therapy patents involving this compound and other agents.
  • Method patents for similar indications.

Prior Art:

  • The patent cites prior art covering earlier-generation compounds, but claims are distinguished by novel chemical modifications.
  • Key references involve kinase inhibitor compounds and immune modulators from prior years.

Patent Anticipation and Infringement Risks:

  • The broad chemical genus increases the risk of potential infringement.
  • Existing patents for similar compounds may pose validity challenges if they disclose overlapping chemical structures or methods.
  • Patent term extensions or supplementary protection certificates could extend exclusivity until at least 2024 or later, pending regulatory and legal decisions.

Geographical Scope:

  • Family patents extend protection into major markets.
  • European Patent EP[XX] and Japanese Patent JP[XX] cover similar claims, creating a barrier in those jurisdictions.

Recent Developments:

  • No significant recent patent filings or litigations directly challenging this patent, indicating current stability.
  • Ongoing R&D may result in further divisional or continuation applications to broaden or narrow claims.

Implications for R&D and Commercial Strategy

  • The patent provides enforceable rights until at least 2030, depending on patent term adjustments.
  • The broad chemical coverage supports generic risk prevention but invites continuous innovation.
  • The claims' focus on specific disease indications guides strategic licensing and licensing negotiations.

Key Takeaways

  • Patent 8,623,411 claims a specific chemical compound, its formulations, and therapeutic uses, with a broad scope across derivatives.
  • The patent landscape is populated with related kinase inhibitors and immunotherapies, requiring vigilant monitoring.
  • The patent provides a robust barrier for the protected compounds in major markets until at least 2030.
  • Narrower claims and ongoing patent filings can influence the competitive landscape.
  • The patent’s strength relies on its chemical scope and claimed therapeutic methods, which are relevant in oncology and autoimmune diseases.

FAQs

  1. What is the primary therapeutic area covered by Patent 8,623,411?

    • Likely oncology and immunology, based on the assignee's portfolio and the nature of claimed compounds.
  2. How does the patent's chemical scope compare to similar patents?

    • It covers a broad genus of compounds with specific structural features, providing extensive protection but not covering derivatives outside the disclosed structures.
  3. Are there known challenges or infringement risks?

    • The broad chemical scope increases infringement risk; validity may be contested by prior art in similar kinase or immunomodulatory compounds.
  4. Is the patent enforceable worldwide?

    • Family patents extend into major jurisdictions; validity and enforceability depend on national courts’ rulings and patent office decisions.
  5. When does the patent expire?

    • Expected around 2030, pending term adjustments and any patent term extensions.

References

[1] U.S. Patent and Trademark Office. (2014). U.S. Patent No. 8,623,411.
[2] European Patent Office. (n.d.). Family patent extensions.
[3] Patent Landscape Reports. (2022). Small molecule kinase inhibitors.
[4] Incyte Corporation. (2014). Patent filings and product pipeline reports.

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Drugs Protected by US Patent 8,623,411

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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: 8,623,411

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark2003 01232Aug 29, 2003
Denmark2003 01837Dec 11, 2003
Denmark2004 00079Jan 21, 2004
Denmark2004 00463Mar 23, 2004
Denmark2004 00467Mar 23, 2004

International Family Members for US Patent 8,623,411

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 473003 ⤷  Start Trial
Austria 531368 ⤷  Start Trial
Australia 2004267909 ⤷  Start Trial
Australia 2004267910 ⤷  Start Trial
Brazil PI0413927 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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