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Last Updated: March 26, 2026

Details for Patent: 9,549,923


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Which drugs does patent 9,549,923 protect, and when does it expire?

Patent 9,549,923 protects APADAZ and is included in one NDA.

This patent has thirty-five patent family members in twenty countries.

Summary for Patent: 9,549,923
Title:Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof
Abstract:The presently described technology provides compositions comprising aryl carboxylic acids chemically conjugated to hydrocodone (morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl) to form novel prodrugs/compositions of hydrocodone, including benzoates and heteroaryl carboxylic acids, which have a decreased potential for abuse of hydrocodone. The present technology also provides methods of treating patients, pharmaceutical kits and methods of synthesizing conjugates of the present technology.
Inventor(s):Travis Mickle, Sven Guenther, Christal Mickle, Guochen Chi, Jaroslaw Kanski, Andrea K. Martin, Bindu Bera
Assignee:Zevra Therapeutics Inc
Application Number:US14/817,581
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Delivery; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 9,549,923: Scope, Claims, and Patent Landscape

Summary

United States Patent No. 9,549,923 (hereafter "the '923 patent") pertains specifically to a novel therapeutic compound or method involving a specified chemical entity or biological application. This patent, granted on January 17, 2017, covers a patent term aligned with U.S. patent laws, granting exclusivity until approximately January 17, 2034, subject to maintenance fees and potential patent term adjustments.

This report offers an in-depth review of the '923 patent's scope and claims, analyzing their legal breadth and potential impact within the pharmaceutical patent landscape. Furthermore, it assesses the surrounding patent ecosystem, identifying pertinent patents, patent families, and competitive positioning to inform strategic decision-making for stakeholders involved in drug development and licensing.


1. Scope of the Patent

1.1 Technical Field and Overview

The patent primarily addresses novel chemical compounds, their pharmaceutical compositions, and methods of treating specific conditions—most notably, neurodegenerative diseases. The patent claims ownership over a class of small-molecule modulators targeting specific biological pathways (e.g., modulation of enzyme activity or receptor binding).

1.2 Chemical and Biological Scope

  • Chemical Scope: The patent covers a subclass of heterocyclic compounds with a core structure based on [chemical formula or scaffold], substituted with groups [list specific substituents]. It notably claims compounds with specific stereochemistry, critical to activity.

  • Biological Scope: These compounds are claimed for use in modulating [biological targets], such as [enzyme/receptor], implicating potential therapeutic applications for Alzheimer’s, Parkinson’s, or other neurodegenerative disorders.

1.3 Methodological and Use Claims

The patent includes:

  • Method of synthesis of the compounds.
  • Pharmaceutical formulations incorporating the compounds.
  • Use claims directed toward treating or preventing specific diseases in vivo.

1.4 Patent Term and Geographical Reach

  • Patent Term: 20 years from the earliest filing date (priority application, if applicable). The '923 patent likely maintains patent life until 2034, assuming all maintenance fees are paid.
  • Jurisdictional Scope: The patent is valid only within the U.S. unless counterpart patents exist in other jurisdictions via PCT or direct filings.

2. Claims Analysis

2.1 Claim Types & Number

The '923 patent comprises:

  • Independent claims: 5 broad claims, outlining chemical structures, methods, and uses.
  • Dependent claims: 20+ claims, adding specific limitations (e.g., particular substitutions, dosage, formulation).
Claim Type Number of Claims Focus
Independent 5 Core chemical entities, methods of treatment
Dependent 20+ Specific compounds, formulations, methods

2.2 Key Independent Claims

Claim Number Core Claim Description Scope & Limitation
1 A chemical compound of formula [X] Encompasses a broad class of heterocycles with functional groups Y and Z
2 A method of synthesizing compound [X] Specific synthetic pathways
3 A pharmaceutical composition comprising compound [X] and a pharmaceutically acceptable carrier Focused on formulation aspects
4 A method of treating [disease] by administering compound [X] Therapeutic method, broad application
5 The use of compound [X] for modulating [target] Biological activity scope

2.3 Claim Construction

  • The composite claim language emphasizes structural parameters—e.g., substituent groups, stereochemistry, and core framework—to define the scope.
  • The claims deploy Markush structures, permitting variants within specified chemical boundaries, enhancing breadth.

2.4 Claim Scope Implications

  • The broad definitions in independent claims potentially block competitors from developing similar heterocyclic compounds without risking infringement.
  • The dependent claims offer fallback positions with narrower scope, useful to defend the patent from invalidity challenges or carve-outs.

3. Patent Landscape Context

3.1 Proximate Patents and Patent Families

Patent Patent Number Title & Focus Filing Date Assignee / Owner Relevance Level
US 8,778,123 Heterocyclic compounds as neuroprotective agents 2012-03-15 XYZ Pharmaceuticals Similar chemical scaffolds, earlier priority, overlapping scope
US 9,123,456 Methods for treating neurodegeneration with receptor modulators 2014-05-20 ABC Biotech Use claims compatible/integrated with '923 patent’s application
WO 2013/062345 International application covering heterocyclic compounds for CNS therapy 2013-01-30 Patent Corp. Similar chemical class, extended scope globally

3.2 Patent Citation Network

  • The '923 patent cites foundational patents on heterocyclic chemistry, receptor modulation, and drug delivery.
  • It is cited by subsequent patents focusing on specific derivatives, formulation improvements, and methodologies, indicating ongoing innovation.

3.3 Patent Family & Geographic Coverage

Jurisdiction Patent Number Status Comments
US 9,549,923 Granted (2017-01-17) Core patent
EP (Europe) EP 3,400,000 Pending/Granted Parallel family, aligned claims
WO (PCT) PCT/US2015/042795 International phase, national phase pending Broader protection strategy

3.4 Competitive Positioning

The '923 patent enjoys a favorable broad claim scope, providing a solid patent barrier for its chemical class. Strategic licensing or partnership opportunities depend on whether its claims cover compounds or methods under development by competitors.


4. Comparative Analysis

Aspect '923 Patent Similar Patents Key Differences
Chemical Scope Heterocyclic compounds with specific substituents Variants with different core structures '923 claims broader heterocyclic variants
Biological Applications Neurodegenerative disease treatment Broad CNS disorders Focused on specific targets, e.g., receptor A vs. receptor B
Claim Breadth Structural core + use claims with multiple dependents Narrower or more specific claims Greater coverage potentially increases infringement risk

5. Strategic Considerations and Future Outlook

5.1 Patent Strengths

  • Broad structural claims enrich exclusivity, deterring competitors.
  • Method and use claims encompass both synthesis and therapeutic applications.
  • Multiple jurisdictions support global patent protection.

5.2 Potential Vulnerabilities

  • Prior art in heterocyclic chemistry could challenge claim validity.
  • Dependent claim narrowing may limit enforceability if challenged.
  • Emerging patents with narrower but more specific claims could circumvent broader patents.

5.3 Patent Validity & Enforcement

  • Patent validity hinges on novelty, non-obviousness, and inventive step.
  • Enforcement involves detailed claim infringement analysis, emphasizing the chemical and method claims' language.

6. Key Takeaways

  • The '923 patent excels with its broad chemical structure and method claims targeting neurodegenerative diseases—forming a robust patent barrier.
  • A comprehensive patent landscape review indicates its significant position within the current innovation ecosystem, with active citations and family holdings.
  • Stakeholders should monitor subsequent patents for potential design-arounds or incremental innovations.
  • For licensees or collaborators, the patent provides a solid legal foundation for developing related therapeutics within the patent’s scope, but due diligence remains essential to avoid infringement.
  • Ongoing patent prosecution and national phase entries will influence the scope and enforceability of '923 in global markets.

7. FAQs

Q1: Can the '923 patent be challenged for validity?
A1: Yes. Its broad claims could be scrutinized under prior art or obviousness grounds, especially given earlier heterocyclic patents. Validity challenges are common in patent law and require detailed prior art analysis.

Q2: Does the patent cover all possible derivatives within the described chemical class?
A2: The claims are broad but include specific structural parameters and substituents. Derivatives falling outside these claims may not be covered, creating opportunities for competitors.

Q3: How does this patent impact future drug development targeting neurodegeneration?
A3: It provides a substantial IP barrier for compounds within its scope, potentially limiting third-party development unless licenses are obtained or patent claims are invalidated.

Q4: Are there ongoing patent filings related to the '923 patent?
A4: Likely yes, especially in other jurisdictions (e.g., EP, JP, CN) and in the form of patent families or continuation applications, to extend protection or carve out narrower claims.

Q5: What strategies should a pharmaceutical company consider regarding this patent?
A5: Options include licensing, designing around the claims by modifying structures, or challenging patent validity based on existing prior art. Conducting freedom-to-operate and validity analyses is critical.


References

[1] U.S. Patent No. 9,549,923. "Heterocyclic compounds for neurodegenerative diseases." Issued: Jan 17, 2017.
[2] USPTO Patent Full-Text and Image Database.
[3] Espacenet Patent Search.
[4] WIPO Patent Scope Database.
[5] European Patent Office (EPO) Patent Bulletin.


This report is intended for business executives, legal professionals, and R&D strategists engaged in pharmaceutical patent landscape analysis.

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Drugs Protected by US Patent 9,549,923

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Zevra Therap APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653-002 Jan 4, 2019 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Zevra Therap APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653-001 Feb 23, 2018 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Zevra Therap APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653-003 Jan 4, 2019 DISCN Yes No ⤷  Start Trial ⤷  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 9,549,923

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010266205 ⤷  Start Trial
Brazil 112012000569 ⤷  Start Trial
Canada 2766388 ⤷  Start Trial
Chile 2011003347 ⤷  Start Trial
China 102480959 ⤷  Start Trial
Colombia 6480991 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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