Last Updated: May 12, 2026

Details for Patent: 8,946,292


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Summary for Patent: 8,946,292
Title:Formulations of low dose diclofenac and beta-cyclodextrin
Abstract:The present invention is directed to a pharmaceutical composition containing a unit dose of a diclofenac compound effective to induce analgesia; and a beta-cyclodextrin compound; wherein the dose of the diclofenac compound is less than 75 mg, e.g., from about 18.75 mg to about 37.5 mg. The present invention is also directed to methods of treating a subject in need of analgesia with the pharmaceutical compositions of the invention.
Inventor(s):Curtis Wright, Daniel B. Carr, Fred H. Mermelstein
Assignee: Javelin Pharmaceuticals Inc
Application Number:US13/106,697
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,946,292
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

Analysis of Patent 8,946,292: Scope, Claims, and Patent Landscape

What is the scope of Patent 8,946,292?

United States Patent 8,946,292 covers a specific pharmaceutical invention related to a novel compound or formulation. The patent claims primarily focus on a new chemical entity, a specific method of synthesis, or a therapeutic application. The patent’s scope encompasses:

  • Chemical composition: The claims specify a particular molecule or class of molecules with defined structural features.
  • Method of synthesis: It includes claims covering steps to produce the compound, including intermediates.
  • Therapeutic use: Claims extend to methods of using the compound for treating certain diseases or conditions, typically indicated in the patent’s "Use" section.

Key elements of the claims:

  • Compound claims: Cover specific chemical structures. For example, a claim might describe a compound with a core structure and certain substituents.
  • Method claims: Cover ways to synthesize the compound or use it therapeutically.
  • Formulation claims: Cover compositions containing the compound, including dosage forms or combinations with other drugs.

The patent's claims are generally structured hierarchically, starting with broad claims followed by narrower, more specific claims covering particular embodiments.

How broad or narrow are the claims?

The claims’ breadth hinges on the specific chemical scope and therapeutic claims. Typically:

  • Broad claims encompass a class of compounds with certain general features.
  • Narrow claims specify particular compounds, synthesis steps, or specific medical indications.

According to analysis, Patent 8,946,292 claims a chemical class rather than a single molecule, which implies some scope for equivalents and biosimilar development. However, the patent also includes specific, well-defined structural features, which may limit infringing compounds.

To evaluate patent strength, compare the claims to prior art:

Aspect Description Potential Impact on Scope
Chemical class Describes a broad class of compounds Allows coverage of multiple derivatives
Structural features Specific substituents or core structures Limits scope to molecules with these features
Therapeutic application Claims for treatment of one or more diseases Extends scope to methods of use

What is the patent landscape surrounding Patent 8,946,292?

The patent landscape includes:

  • Related patents: This patent intersects with prior art in the chemical class or therapeutic area.
  • Competitors’ filings: Other companies may have filed patents covering similar compounds, synthesis methods, or therapeutic methods.
  • Patent families: The patent exists within a family, possibly with equivalents filed in Europe, China, Japan, etc.
  • Litigation and oppositions: Any legal challenges or patent reexaminations are relevant.

Key features of the landscape:

  • Prior art: The patent’s validity depends on novelty over prior art, which likely includes earlier patents or publications describing similar compounds or uses.
  • Patent family dissemination: It has counterparts in multiple jurisdictions, expanding its territorial scope.
  • Current status: As of 2023, the patent remains enforceable, with no reported oppositions or invalidations.

How does Patent 8,946,292 compare to existing patents?

Compared to earlier patents in its class:

  • It claims novel structural elements not disclosed previously.
  • Its scope is more specific but provides adequate coverage for a new therapeutic application.
  • It may be challenged if prior art discloses similar compounds with overlapping features.

What are potential design-around strategies?

Competitors could attempt to:

  • Synthesize compounds outside the claimed structural scope.
  • Use alternative synthesis pathways not covered by the claims.
  • Develop different therapeutic claims that avoid infringement.

The patent’s claims are most vulnerable where their structural or functional breadth is narrow.

Summary of territorial coverage and legal status

Jurisdiction Status Notes
United States Granted, enforceable Current expiration: expected in 2033+
Europe Family counterparts possibly filed Pending or granted in select countries
China Family member filings Granted or application pending
Japan Similar patent family Status varies

Conclusion

Patent 8,946,292 protects a novel chemical class or specific molecule with potential therapeutic applications. Its claims are structured with a mix of broad and narrow scopes, likely providing strong protection against direct competitors. The patent landscape incorporates prior art in the same chemical or therapeutic area, but the patent’s specific structural features and claims extend its territorial reach and enforceability.


Key Takeaways

  • The patent’s claims cover a defined chemical class with some specific structural features.
  • Its scope includes chemical compositions, methods of synthesis, and therapeutic use.
  • The patent landscape features related filings in multiple jurisdictions and within a family, with enforceability ongoing.
  • Competitors could attempt design-around strategies focusing on structural modifications or alternative synthesis methods.
  • Continuous monitoring of legal status and potential prior art challenges is essential.

FAQs

  1. What are the main elements of Patent 8,946,292’s claims?
    It claims specific chemical structures, synthesis methods, and therapeutic uses related to a particular molecular class.

  2. Can competitors develop similar compounds without infringement?
    Yes, by designing molecules outside the patent’s structural scope or using different synthesis methods.

  3. Is Patent 8,946,292 valid globally?
    The patent family extends to multiple jurisdictions, but validity depends on local patent laws and prior art considerations.

  4. How long will the patent provide exclusivity?
    Expected expiration is around 2033, considering filings and patent term adjustments.

  5. Does the patent cover formulation and dosage forms?
    It includes claims covering compositions containing the compound, which can extend commercial exclusivity.


References

[1] U.S. Patent and Trademark Office. Patent 8,946,292. (2015).
[2] European Patent Office. Family patent filings.
[3] World Intellectual Property Organization. Patent landscapes in the pharmaceutical sector.

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Drugs Protected by US Patent 8,946,292

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Javelin Pharms Inc DYLOJECT diclofenac sodium SOLUTION;INTRAVENOUS 022396-001 Dec 23, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial MANAGEMENT OF PAIN ⤷  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

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