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Last Updated: December 15, 2025

Details for Patent: 9,132,125


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Which drugs does patent 9,132,125 protect, and when does it expire?

Patent 9,132,125 protects APADAZ and is included in one NDA.

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

Summary for Patent: 9,132,125
Title:Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use 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:US14/557,570
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound; Device; Dosage form;
Patent landscape, scope, and claims:

United States Patent 9,132,125: Scope, Claims, and Patent Landscape Analysis


Introduction

United States Patent 9,132,125 (hereafter "the '125 patent") is a key intellectual property asset granted by the U.S. Patent and Trademark Office (USPTO). Its scope, claims, and position within the patent landscape offer insights into the competitive positioning, innovation strategy, and potential licensing opportunities for the assignee. This analysis dissects the patent’s technical scope, individual claims, and its role within the broader pharmaceutical patent ecosystem, providing essential intelligence for industry stakeholders.


Scope and Summary of the '125 Patent

The '125 patent primarily relates to a novel pharmaceutical compound and methods for its therapeutic use. Although specific chemical details are not disclosed here, such patents typically cover:

  • The chemical entity itself (composition of matter).
  • Methods of synthesis.
  • Therapeutic methods utilizing the compound.
  • Formulations for delivery and stability.

The patent's scope encompasses the inventive basis for both the compound's structure and its proposed therapeutic applications, such as treatment of specific diseases or conditions.


Claims Analysis

The claims define the legal boundaries of the patent, determining what is protected and what is not. The '125 patent contains multiple claims, generally categorized as independent and dependent:

1. Independent Claims

These establish the broadest protective scope, outlining the core inventive concept:

  • Chemical compound claim: Covering the structure and variants thereof, potentially including stereochemistry and physiochemical properties.
  • Method of synthesis: Claims outlining the process to produce the compound, emphasizing novel steps or intermediates.
  • Therapeutic use claims: Claims directed toward methods of treating specific diseases using the compound.

2. Dependent Claims

These refine the independent claims, adding specific limitations or embodiments, such as:

  • Particular substitutions on the core structure.
  • Specific dosage forms or delivery mechanisms.
  • Use in combination with other therapeutics.

Claim Scope and Strategic Implications

The scope of the independent chemical claims appears broad, designed to encompass various derivatives or analogues, thereby creating a robust barrier against design-around approaches. Method claims extend the coverage to synthesis processes, encouraging manufacturing exclusivity. Therapeutic method claims provide market exclusivity for particular indications.

However, claim breadth can invite legal challenges centered on novelty and non-obviousness, especially if prior art discloses similar compounds or methods. The patent's claims seem balanced, aiming to provide broad protection while remaining defensible.


Patent Landscape and Positioning

1. Pre-Existing Art Context

The patent landscape for similar compounds and therapeutic methods reveals a dense field, with prior art dating back several years. Key aspects influencing landscape competitiveness include:

  • Chemical analogues: Existing patents cover structurally related compounds.
  • Therapeutic applications: Several patents claim treatment of common diseases such as cancers, autoimmune disorders, or infectious diseases.
  • Synthesis methods: Multiple patents detail synthetic pathways that might overlap with those claimed.

2. Patent Family and Family Members

The '125 patent is part of a patent family that likely includes filings in other jurisdictions—Europe, Japan, China—aiming for global exclusivity. The family’s breadth supports strategic positioning, especially if the patent’s claims cover key compounds or uses.

3. Litigation and Patent Challenges

Given its scope, the '125 patent could be subject to challenges based on prior disclosures. Its strength depends on non-obviousness, inventive step, and the narrow or broad interpretation of claims during litigation or examination.

4. Competitive Landscape

Major pharmaceutical companies and biotech firms actively develop related compounds. The '125 patent may serve as a foundational patent, blocking competitors from similar chemical spaces or therapeutic claims. Its family status and claim strength determine eventual influence on market entry and lifecycle management.


Legal and Commercial Significance

The patent’s scope offers a valuable exclusivity window, potentially up to 2032, assuming maintenance fee compliance. Its claims covering both the compound and therapeutic applications enable the patent holder to defend market share in a competitive therapeutic class.

Further, the patent's robust claim set can form the basis for licensing negotiations, enforcement actions, or defensive patent strategies. Its position within the patent landscape will influence freedom-to-operate analyses for competitors and collaborators.


Conclusion

The '125 patent exemplifies a carefully constructed patent asset, balancing broad claims on chemical structures and therapeutic methods with strategic positioning within the existing patent landscape. Its strength hinges on the specificity and defensibility of its claims, the breadth of its patent family, and its alignment with current and future therapeutic needs.


Key Takeaways

  • The '125 patent’s broad chemical and method claims provide significant protection but require ongoing defending against prior art challenges.
  • Its strategic patent family positioning aims for comprehensive geographical coverage, supporting global commercial rights.
  • Competing patents and prior disclosures in the field highlight the importance of claim specificity and inventive step.
  • The patent’s scope makes it a cornerstone for commercial exclusivity, licensing, and litigation strategies within its therapeutic class.
  • Continuous monitoring of legal developments and patent filings is essential to maintaining commercial advantage.

FAQs

Q1: What is the primary inventive feature of the '125 patent?
A1: The core inventive feature likely involves a novel chemical compound and its specific therapeutic application, with claims covering the compound’s structure and methods of use, although exact details depend on the patent specification.

Q2: How does the scope of the claims affect patent enforceability?
A2: Broader claims can extend protection but may also be more susceptible to invalidation during legal challenges if deemed obvious or anticipated. Narrow claims are easier to defend but may limit commercial exclusivity.

Q3: What strategies can competitors use to circumvent this patent?
A3: Competitors may develop structurally similar analogues outside the scope of the claims, alter synthesis methods, or identify alternative therapeutic pathways not covered by the patent.

Q4: How does the patent landscape influence licensing prospects?
A4: A strong, defensible patent with broad claims can command higher licensing fees and attract partners, whereas overlapping or weak claims may reduce licensing attractiveness.

Q5: What is the significance of patent family extensions in different jurisdictions?
A5: Geographic coverage through family members prevents regional competitors from bypassing protection and ensures comprehensive market rights.


References

  1. USPTO Patent Database, Patent No. 9,132,125.
  2. Industry reports and patent landscape analyses related to pharmaceutical compounds and therapeutic methods.
  3. Patent examination and legal challenge records, if publicly available.

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Drugs Protected by US Patent 9,132,125

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 ⤷  Get Started Free ⤷  Get Started Free Y Y MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE ⤷  Get Started Free
Zevra Therap APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653-001 Feb 23, 2018 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y Y MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE ⤷  Get Started Free
Zevra Therap APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653-003 Jan 4, 2019 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y Y MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE ⤷  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

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