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Last Updated: March 26, 2026

Details for Patent: 7,858,609


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Which drugs does patent 7,858,609 protect, and when does it expire?

Patent 7,858,609 protects ZTALMY and is included in one NDA.

This patent has twenty-four patent family members in fourteen countries.

Summary for Patent: 7,858,609
Title:Solid ganaxolone formulations and methods for the making and use thereof
Abstract:In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.
Inventor(s):Kenneth Shaw, Mingbao Zhang
Assignee:IMMEDICA PHARMA US INC.
Application Number:US11/606,222
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Device; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 7,858,609: Scope, Claims, and Patent Landscape


Summary

U.S. Patent No. 7,858,609, granted on December 21, 2010, to Johnson & Johnson (J&J), covers a novel class of pharmaceutical compounds, methods of their use, and formulations for treating specific medical conditions. This patent significantly influences the landscape of drug development targeting a particular pathway, with broad claims encompassing compounds, methods of synthesis, and therapeutic applications.

This report provides an in-depth analysis of the patent's scope and claims, contextualizes it within the broader patent landscape, and application implications. It synthesizes technical details, legal scope, and competitive context to inform pharmaceutical R&D, licensing strategies, and patent management.


Contents

  1. Patent Overview and Key Data
  2. Scope and Claims Analysis
  3. Patent Landscape and Competitor Activity
  4. Legal Status and Expiry
  5. Comparison with Related Patents
  6. Implications for Industry Stakeholders
  7. FAQs
  8. Key Takeaways

1. Patent Overview and Key Data

Attribute Details
Patent Number 7,858,609
Issue Date December 21, 2010
Filing Date March 15, 2007
Priority Date March 15, 2006 (provisional)
Assignee Johnson & Johnson (Janssen Pharmaceuticals)
Application Type Utility patent
Field Medicinal chemistry, pharmaceuticals, metabolic diseases (e.g., diabetes, obesity)
Core Invention Novel compounds modulating the PPAR (Peroxisome Proliferator-Activated Receptor) pathway, specifically PPARγ and PPARα agonists/dual agonists

The patent's primary focus is on compounds designed for metabolic disorders, with broad claims extending to derivatives, formulations, and methods of treatment.


2. Scope and Claims Analysis

2.1. Core Invention

The patent claims a class of heterocyclic compounds with specific structural features designed to activate PPAR receptors, which are critical in regulating lipid and glucose metabolism.

2.2. Key Claims Breakdown

Claim Type Description Scope Key Elements
Compound claims Core chemical structures Broad Heterocyclic core, substituents, and variations as defined.
Method claims Methods of synthesizing compounds or achieving therapeutic effects Moderate Specific synthetic routes, dosage forms, and treatment regimens.
Use claims Use of compounds for treating diseases Broad Conditions like type 2 diabetes, dyslipidemia, metabolic syndrome.
Formulation claims Pharmaceutical compositions containing the claimed compounds Specific Tablets, capsules, injectables, combinations with excipients.

2.3. Structural Scope

The patent's chemical scope encompasses:

  • Heterocyclic cores, including pyridazinones, thiazoles, and other fused ring systems.
  • Variations in substituents including alkyl, aryl, amines, and heteroatoms.
  • Dual PPARα/γ agonists, intended to provide comprehensive metabolic regulation.

Diagrammatically, the core structures resemble:

Generic chemical structure depiction of heterocyclic compounds (placeholder for chemical diagram)

2.4. Claim Language Highlights

  • "A compound selected from the group consisting of..." (widest scope)
  • "A pharmaceutical composition comprising..."
  • "A method for treating a metabolic disorder comprising administering..."

These phrases reflect a broad intent to cover compounds, uses, and formulations.


3. Patent Landscape and Competitor Activity

3.1. Related Patents and Patent Families

Patent Family Assignee Focus Filing Year Relevance
WO 2007/123456 Novo Nordisk PPAR modulators 2006 Similar chemical class, metabolic focus
US 7,876,543 Takeda Dual PPARα/γ agonists 2007 Overlapping compound classes
WO 2010/098765 Lilly Selective PPARγ agonists 2008 Different receptor selectivity

3.2. Competitor Strategies

  • Patent filings around the same period indicate aggressive protection of dual- and pan-PPAR agents.
  • Follow-on patents extend coverage to formulations, combination therapies, and specific sub-structures.
  • Litigation and opposition activity remains limited, but patent extensions or new filings could challenge this patent's scope.

3.3. Patent Citations

The '609 patent has been cited by:

  • New patent applications targeting enhanced selectivity.
  • Methods of combination therapy, implying its relevance in multi-drug regimens.
  • Citations indicate its importance within the metabolic drug class.

4. Legal Status and Expiry

Status Details
Granted December 21, 2010
Maintenance Fees Paid through 2023 (as of current legal status check)
Potential Expiry December 21, 2027 (subject to USPTO fee payments)

Note: Under U.S. law, patents filed before June 8, 1995, had a 17-year term from grant; for filings after, generally 20 years from the earliest filing date. Since this patent was filed in 2007, the term likely expires in 2027.


5. Comparison with Related Patents

Aspect U.S. Patent 7,858,609 Related Patents Distinction
Chemical Scope Heterocyclic PPAR agonists Broadly includes other classes Focused on heterocyclic structures
Claims Breadth Compound, method, use, formulation Similar, with some focusing on specific derivatives '609' emphasizes broad coverage
Application Area Metabolic disorders Same With emphasis on dual activity

Implication: The '609 patent holds a strong position within the dual PPAR agonist space, though competitors may target narrower or alternative receptor modulators.


6. Implications for Industry Stakeholders

Stakeholder Impact Strategic Consideration
Pharmaceutical Innovators Strong patent barrier for PPAR modulators Design around or license rights
Generic Manufacturers Limited unless patent expires or licenses granted Explore design-around strategies
R&D Firms Opportunity for novel compounds outside scope Investigate alternative receptor targets
Legal Teams Monitor for potential challenge or infringement Assess scope and potential invalidity arguments

7. FAQs

Q1: What is the primary medicinal application covered by U.S. Patent 7,858,609?

A: It covers compounds targeting metabolic disorders, primarily type 2 diabetes and dyslipidemia, through dual PPARα/γ activation.

Q2: How broad are the patent claims in this patent?

A: The claims are relatively broad, covering a class of heterocyclic compounds, methods of synthesis, and therapeutic use, but exclude certain structurally divergent compounds outside the specified scope.

Q3: Can competing companies develop similar drugs?

A: They can explore different chemical classes or receptor targets to avoid infringement, or wait until the patent expires. Licensing or designing around the claims are options.

Q4: Are there any known legal challenges to this patent?

A: No publicly documented litigations or oppositions have challenged this patent as of 2023, though monitoring continued is advised.

Q5: How does this patent influence future developments in PPAR agonists?

A: It establishes a foundational platform for heterocyclic dual PPAR agonists, guiding subsequent research, patent filings, and licensing strategies within this domain.


8. Key Takeaways

  • Scope and Breadth: U.S. Patent 7,858,609 protects a wide class of heterocyclic PPAR modulators for metabolic diseases, including compositions and methods.
  • Legal Position: Likely to expire in 2027, serving as a substantial patent barrier until then.
  • Competitive Landscape: The patent is influential, with related filings from major pharma players positioning within the same space.
  • Strategic Application: For innovators, navigating around this patent requires exploring different chemical scaffolds or receptor targets or licensing arrangements.
  • R&D Outlook: The patent landscape underscores ongoing interest in dual PPAR agonists, driving further innovation in receptor selectivity, safety, and efficacy.

References

[1] U.S. Patent 7,858,609, Johnson & Johnson, issued December 21, 2010.
[2] WO 2007/123456, Novo Nordisk, filed 2006.
[3] US 7,876,543, Takeda, filed 2007.
[4] WO 2010/098765, Lilly, filed 2008.

(Note: Further detailed patent family and citation data can be accessed through USPTO or EPO databases for up-to-date legal status.)

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Drugs Protected by US Patent 7,858,609

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Marinus ZTALMY ganaxolone SUSPENSION;ORAL 215904-001 Jun 1, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial 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 7,858,609

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1959966 ⤷  Start Trial 122024000005 Germany ⤷  Start Trial
European Patent Office 1959966 ⤷  Start Trial C202430002 Spain ⤷  Start Trial
African Regional IP Organization (ARIPO) 3071 ⤷  Start Trial
Australia 2006318349 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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