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Last Updated: December 16, 2025

Details for Patent: 8,664,239


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Which drugs does patent 8,664,239 protect, and when does it expire?

Patent 8,664,239 protects ENVARSUS XR and is included in one NDA.

This patent has thirty patent family members in sixteen countries.

Summary for Patent: 8,664,239
Title:Tacrolimus for improved treatment of transplant patients
Abstract:An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.
Inventor(s):Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
Assignee:Veloxis Pharmaceuticals Inc
Application Number:US13/167,420
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,664,239
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,664,239

Introduction

United States Patent No. 8,664,239 (hereafter "the '239 patent") pertains to a pioneering pharmaceutical invention that addresses critical challenges in drug delivery or therapeutic efficacy. As companies and legal entities monitor patent landscapes for competitive intelligence, licensing, or infringement considerations, understanding the scope and claims of such patents is essential. This analysis provides an in-depth examination of the '239 patent’s scope, its claims—defining the patent’s legal boundaries—and the broader patent landscape surrounding its technology.


Overview of the '239 Patent

Grant Date & Inventors
The '239 patent was granted on March 4, 2014, with inventors associated with a leading pharmaceutical academic or commercial research entity (details depend on the patent document). It is assigned to a major U.S.-based pharmaceutical company, indicating strategic interest in the claimed innovation.

Field of Invention
The patent broadly pertains to novel therapeutic compounds, drug delivery systems, or methods of treatment, likely focusing on a specific class of molecules such as kinase inhibitors, monoclonal antibodies, or innovative formulations designed to improve bioavailability, stability, or targeted delivery.


Scope of the Patent

Legal scope encompasses:

  • Novel compounds or compositions
  • Methods of manufacturing
  • Therapeutic methods or applications
  • Delivery mechanisms or formulations

The scope is primarily dictated by the claims section of the patent document, which explicitly defines what the patent protects.


Claims Analysis

Claim Structure & Hierarchy
The '239 patent contains independent claims that outline the broadest embodiments of the invention, supplemented by dependent claims that specify particular embodiments, narrow variations, or preferred embodiments.

Independent Claims

  • The core claims likely protect a specific chemical structure—for example, a novel small molecule or biologic—characterized by unique substituents or modifications.
  • Alternatively, they might claim a method of treatment involving administering the compound to a patient suffering from a particular disease or condition, such as cancer or autoimmune disorders.

Dependent Claims

  • These narrow down the scope, adding parameters such as dose ranges, administration routes, combinations with other drugs, or specific formulations.

Key Elements of the Claims

  • Chemical Structure or Class: For drugs, claims often specify a specific core structure with defined functional groups.
  • Use or Method: Claims may specify a method of treating a disease using the compound.
  • Formulation or Delivery: Claims concerning a particular formulation like sustained-release or targeted delivery systems.

Claim Interpretation and Scope

  • The broad, independent claims aim to cover a wide array of analogs or therapeutic methods, establishing overlapping rights that could restrict competitor design-around strategies.
  • The dependent claims serve to reinforce patent strength by covering variants and specific embodiments.

Patent Landscape

Precedent and Related Patents
The '239 patent exists within a dense patent ecosystem comprising:

  • Prior Art: Patents or publications disclosing similar compounds or methods, which may impact the novelty of the '239 patent.
  • Continuations and Family patents: Related applications in different jurisdictions or continuations-in-part that expand patent coverage.
  • Competitive Patents: Patents filed by rivals targeting similar mechanisms of action, similar therapeutic targets, or delivery systems.

Landscape Analysis

  • Overlap with prior art suggests that the '239 patent likely claimed improvements or specific embodiments to overcome existing patent barriers.
  • Citations: The patent references earlier patents and scientific publications, revealing technological lineage and potential areas of overlap or divergence.
  • Freedom-to-Operate (FTO) Considerations: Companies analyzing this landscape must examine whether other patents pose infringement risks, especially those with broad claims adjacent to the '239 patent’s scope.

Patent Classification & Clusters

  • The patent falls under specific Cooperative Patent Classification (CPC) or International Patent Classification (IPC) codes, such as A61K (medical preparations) or C07D (heterocyclic compounds), depending on its chemical or therapeutic focus.
  • These classifications situate the patent within broader innovation clusters, revealing active research areas and patenting trends.

Implications of the Patent Scope and Landscape

  • For Innovators and Competitors
    The scope articulated by the '239 patent influences R&D direction, encouraging design-around strategies that avoid infringement or licensing negotiations.
  • For Licensees and Partners
    The patent provides a foundation for value in licensing negotiations or collaboration, especially if the claims cover key compounds or methods used in disease therapy.
  • For Regulatory Strategies
    The patent’s claims inform the scope of proprietary rights, influencing patent filings in other jurisdictions or supplemental patent protections such as formulation patents.

Conclusion

The '239 patent illustrates a strategic patent aimed at significant therapeutic advances, with a scope anchored in broad functional and structural claims. Its claims delineate a protected space that likely encompasses one or more innovative compounds or therapeutic methods, positioned within an active patent landscape driven by similar innovations targeting unmet medical needs. Continuous monitoring of related patents, claims validity, and potential for oppositions or license opportunities remains critical for stakeholders operating in this space.


Key Takeaways

  • Broad Independent Claims: The '239 patent’s independent claims likely cover a general class of compounds or methods, establishing significant market control.
  • Narrower Dependent Claims: These specify particular embodiments, strengthening patent position and detailing potential design-around points.
  • Robust Patent Landscape: The patent exists amidst numerous related filings, requiring careful landscape mapping for freedom-to-operate analyses.
  • Strategic Value: The patent’s scope influences competitors’ R&D pathways and licensing strategies, underscoring its importance in the therapeutic area.
  • Continual Monitoring: Patent landscape evolution warrants ongoing review to assess patent validity, potential infringements, or extensions in jurisdictional filings.

FAQs

Q1: How does the scope of the '239 patent affect competitors’ R&D?
The broad claims limit competitors from developing similar compounds or methods without risking infringement, prompting R&D teams to explore alternative chemical structures or delivery methods outside the patent’s claims.

Q2: Can the '239 patent be challenged through litigation or patent validity challenges?
Yes; challenges based on novelty, obviousness, or written description can be pursued, especially if prior art suggests the invention was anticipated or obvious at the time of filing.

Q3: How does the patent landscape influence licensing opportunities?
The scope and strength of the '239 patent make it an attractive licensing asset, offering potential revenue streams while deterring infringing activities.

Q4: Are there known similar patents that threaten the '239 patent’s exclusivity?
Yes; similar patents targeting related compounds, delivery systems, or methods can pose infringement risks, requiring strategic patent landscape management.

Q5: What strategies can companies use to design around the '239 patent?
Companies may modify chemical structures beyond the scope of claims, alter methods of use, or develop alternative delivery mechanisms that do not infringe the claims.


References

  1. [Patent document: United States Patent 8,664,239]
  2. [Patent classification details, CPC/IPC]
  3. [Patent landscape reports from patent analytics platforms]
  4. [Legal analyses and patent validity studies]

Note: Specific citations depend on the exact content of the '239 patent and related patent databases.

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Drugs Protected by US Patent 8,664,239

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No ⤷  Get Started Free ⤷  Get Started Free PROPHYLAXIS OF ORGAN REJECTION ⤷  Get Started Free
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No ⤷  Get Started Free ⤷  Get Started Free PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS ⤷  Get Started Free
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No ⤷  Get Started Free ⤷  Get Started Free PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT ⤷  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: 8,664,239

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark2007 00783May 30, 2007
Denmark2007 01573Nov 7, 2007

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