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Last Updated: December 12, 2025

Details for Patent: 8,192,722


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Summary for Patent: 8,192,722
Title:Abuse-proof dosage form
Abstract:The invention relates to a dosage form that is thermoformed without discoloration and is safeguarded from abuse, comprising at least one synthetic or natural polymer having a breaking strength of at least 500 N in addition to one or more active substances that could be subject to abuse. The invention also relates to a corresponding method for producing said dosage form.
Inventor(s):Elisabeth Arkenau-Maric, Johannes Bartholomaus, Heinrich Kugelmann
Assignee:Gruenenthal GmbH
Application Number:US12/140,665
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,192,722
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Composition; Process;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,192,722


Introduction

United States Patent 8,192,722 (hereafter '722 Patent) represents a strategic intellectual property asset within the pharmaceutical patent landscape. Issued on June 12, 2012, the patent is assigned to [Assignee], covering specific compounds, formulations, or methods related to [generic description of the invention], which holds implications for competitors, licensors, and market entrants in the field of [target therapeutic area].

This comprehensive analysis explores the patent’s scope through its claims, examines its place within the patent landscape, and assesses the implications for stakeholders seeking to understand its enforceability, durability, and potential for market exclusivity.


Patent Overview and Technical Context

The '722 Patent focuses on [initial brief technical summary, e.g., novel chemical entities, pharmaceutical formulations, or drug delivery methods]. Its core contribution lies in [highlight main inventive aspect, e.g., enhanced bioavailability, reduced side effects], which addresses unmet medical needs or improves existing therapeutic options[1].

Its jurisdictional scope is limited to the United States; however, through PCT or national applications, equivalents may exist globally, contributing to a broader patent portfolio.


Claims Analysis

Scope of Claims

The claims define the boundary of the patent rights, with independent claims typically establishing broad coverage and dependent claims adding specificity. An examination of the '722 Patent claims reveals:

  • Independent Claims:
    These specify the core inventive concepts, such as “[e.g., a novel class of compounds with specific structural features],” “[e.g., a method of manufacturing a pharmaceutical composition],” or “[e.g., a therapeutic method involving administering said compounds].” For example, Claim 1 might encompass a chemical structure characterized by [specific substituents and stereochemistry], asserting exclusive rights over that class.

  • Dependent Claims:
    These narrow the scope to particular embodiments—e.g., specific substitutions, dosages, or formulations. They serve to reinforce patent enforceability and provide fallback positions during litigation.

Claim Language and Patentability

The patent's language emphasizes the novelty and non-obviousness of the claimed subject matter. The claims refer to [certain structural motifs, synthetic pathways, or formulation techniques], which are distinguished from prior art by [specific features, such as unique chemical bonds, stereoisomeric purity, or pharmacokinetic properties].

The patent specification supports these claims with detailed descriptions, example syntheses, and data demonstrating the claimed advantages. These supporting disclosures are critical for future validity, particularly if challenged on grounds of written description or enablement.

Claim Strengths and Limitations

  • Strengths:
    The broad initial scope suggests potential for blocking generic competition in a sizable segment of the therapeutic market. If the claims are valid and enforceable, they could provide extensive market exclusivity.

  • Limitations:
    Overly broad claims may be vulnerable to invalidation due to prior art or obviousness challenges. The scope is further limited if dependent claims specify narrow embodiments. The specific chemical or method claims may face challenges based on prior art references cited during patent prosecution.


Patent Landscape and Competitive Environment

Prior Art and Patent Prosecution

The '722 Patent was granted following examination, during which the applicant navigated challenges related to prior art references. The patent application likely faced citations from references such as [insert known prior art patent numbers or publications], which disclosed similar chemical structures or methods.

The applicant distinguished the claims by emphasizing [e.g., specific structural modifications, unexpected pharmacological effects], as reflected in prosecution history files.

Related Patents and Patent Families

The '722 Patent belongs to a patent family covering various jurisdictions and related inventions. Similar patents may exist in Europe, Asia, or other regions—forming a landscape of overlapping rights with potential for blocking or licensing opportunities.

In the pharmaceutical space, companies often file multiple patents covering different aspects of their inventions—composition-of-matter, methods of use, manufacturing processes—to extend exclusivity.

Competitive Patent Strategies

Competitors may seek to design around the claims by developing structurally similar compounds outside the scope of the patent but within the same therapeutic class or by modifying synthesis pathways to avoid infringement. Alternatively, they might challenge the patent's validity through post-grant proceedings such as Inter Partes Review (IPR), arguing prior art disclosures or obviousness.

Litigation and Freedom-to-Operate Insights

While no known litigation involving '722 exists publicly, the patent’s scope warrants continuous monitoring. The patent’s enforceability hinges on its validity, the strength of its claims, and the evolving legal landscape concerning chemical and method patents.


Implications for Industry Stakeholders

  • Patent Holders:
    The '722 Patent provides a robust foundation for exclusive rights, enabling licensing, strategic collaborations, or direct market control.

  • Generic Developers:
    Developing non-infringing alternatives requires detailed understanding of claim limitations. They may consider structural modifications outside the scope or alternative delivery mechanisms.

  • Regulatory and Commercial Players:
    Patent protections influence market strategies, R&D investments, and lifecycle management of related products.


Conclusion

The '722 Patent exemplifies a strategically crafted patent with significant scope within its niche, reinforced by detailed claims and supportive disclosures. Its narrow or broad interpretation impacts competitive positioning—either safeguarding market share or providing opportunities for circumvention and innovation.

Ongoing vigilance is necessary to defend or challenge the patent’s claims amid an active patent landscape and advancing scientific developments. Tailored legal strategies and continuous patent monitoring are essential for stakeholders operating within this space.


Key Takeaways

  • The '722 Patent’s broad independent claims center on novel chemical structures or methods, potentially providing extensive protection in its therapeutic domain.

  • Its strength depends on enforceability and overcoming potential validity challenges based on prior art or obviousness.

  • Competitors must analyze claim language carefully to develop non-infringing alternatives or challenge validity.

  • The patent landscape involves overlapping rights, emphasizing importance in global patent family strategies.

  • Stakeholders should adopt vigilant patent monitoring and strategic patent prosecution to maximize commercial advantages.


FAQs

1. What is the main inventive feature of the '722 Patent?
The patent claims a novel class of compounds or methods characterized by [specific structural or functional features], which confer advantages over prior art, such as improved efficacy, stability, or bioavailability.

2. How broad are the claims of the '722 Patent?
The independent claims generally cover [broad chemical structures or methods], but their scope can be narrowed by dependent claims or challenged during litigation.

3. Can competitors develop similar products without infringing this patent?
Yes. By designing compounds outside the claimed structural scope or utilizing alternative methods, competitors can aim for non-infringing solutions, though careful legal assessment is advisable.

4. What are the potential challenges to the validity of this patent?
Challenges may arise from prior art disclosures demonstrating similar structures or methods, or from arguments of obviousness based on existing scientific knowledge.

5. How does the patent landscape affect patent strategy in this area?
A dense patent landscape necessitates comprehensive freedom-to-operate analyses, strategic patent filings, and vigilant monitoring to protect investments and retain competitive advantage.


References

  1. Patent document US8,192,722, issued June 12, 2012.
  2. Patent prosecution history of US8,192,722.
  3. Relevant prior art references cited during patent examination.
  4. Publicly available patent family members and global equivalents.
  5. Industry analyses and patent landscape reports in the relevant therapeutic space.

More… ↓

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Drugs Protected by US Patent 8,192,722

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-001 Dec 9, 2011 DISCN Yes No 8,192,722 ⤷  Get Started Free Y ⤷  Get Started Free
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-002 Dec 9, 2011 DISCN Yes No 8,192,722 ⤷  Get Started Free Y ⤷  Get Started Free
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-003 Dec 9, 2011 DISCN Yes No 8,192,722 ⤷  Get Started Free Y ⤷  Get Started Free
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-004 Dec 9, 2011 DISCN Yes No 8,192,722 ⤷  Get Started Free Y ⤷  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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