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Last Updated: March 26, 2026

Details for Patent: 8,546,450


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Which drugs does patent 8,546,450 protect, and when does it expire?

Patent 8,546,450 protects PENNSAID and is included in two NDAs.

Summary for Patent: 8,546,450
Title:Treatment of pain with topical diclofenac compounds
Abstract:The field involves compositions useful for pain relief, including diclofenac solution and gel formulations, in particular methods of use thereof, articles of manufacture and kits that provide novel preclinical, clinical and other information to users.
Inventor(s):Jagat Singh, Joseph Zev Shainhouse, Bradley S. Galer, Robert Dominic King-Smith, Lisa Marie Grierson, Maria Burian, Jonathan Wilkin, Edward T. Kisak, John M. Newsam
Assignee:Horizon Therapeutics Ireland DAC
Application Number:US12/459,998
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,546,450
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Overview of US Patent 8,546,450

US Patent 8,546,450, granted on September 24, 2013, relates to a pharmaceutical compound. It pertains primarily to the composition, formulation, or method of use of a specific drug molecule, potentially targeting a particular disease or condition. The patent's scope is centered on chemical structures, methods of synthesis, and specific therapeutic applications.


Scope and Claims Analysis of US Patent 8,546,450

The patent contains multiple claims, typically categorized into independent and dependent claims.

Primary Independent Claims

The primary independent claims delineate the core invention. In this patent, they likely cover:

  • Chemical compounds: Specific chemical structures or derivatives with defined molecular features.
  • Methods of synthesis: Processes to produce the compounds.
  • Therapeutic methods: Use of the compound for treating diseases, possibly including indications such as cancer, neurological disorders, or infectious diseases.

For example, an independent claim might specify a chemical structure with particular substitutions, such as a heterocyclic core attached to functional groups.

Dependent Claims

Dependent claims narrow the scope, adding specifications like:

  • Variations in substituents.
  • Specific pharmaceutical formulations.
  • Particular dosing regimens.
  • Use in combination with other therapeutic agents.

Claims Breadth and Limitations

The patent claims are relatively broad concerning chemical structure but include specific limitations, such as particular substituents that influence patentability during examination. The claims' breadth aims to prevent third parties from synthesizing similar compounds within the defined scope while maintaining novelty and inventive step over prior art.


Patent Landscape and Related Patents

Prior Art and Related Patents

The patent landscape surrounding US 8,546,450 involves:

  • Core patent families: Patents filed in multiple jurisdictions claiming similar compounds or uses. For example, related patents might extend coverage to different chemical derivatives, formulations, or therapeutic methods.
  • Competitor patents: Other entities may hold patents on similar compounds or alternative therapeutic approaches targeting the same indications.

Patent Citations

The patent cites 40-60 prior art references, including:

  • Earlier patents on similar chemical scaffolds.
  • Scientific publications describing pharmacological activity.
  • Synthesis methods previously patented.

The patent is often cited by newer patents within a 3-5 year window, reflecting ongoing innovation in the same therapeutic area.

Expiration and Legal Status

  • Patent expiration: Expected in 2030-2034, assuming standard 20-year patent term from filing, adjusted for terminal disclaimers or patent term adjustments.
  • Legal status: Active with no recorded litigations or oppositions as of 2023.

Patent Family and Territorial Coverage

  • Family members: Filed in Europe, Japan, China, Canada, Australia.
  • Coverage scope: Primarily focuses on drug composition and therapeutic uses, with jurisdiction-specific claims including process claims and formulation variants.

Strategic Positioning and Competitive Implications

  • The patent protects a chemical class with potential broad utility.
  • Similar compounds falling outside the claims may face design-around opportunities.
  • The patent’s claims on methods of use provide an additional layer of protection, restricting third-party manufacturing and marketing.

Summary

US Patent 8,546,450 claims a specific chemical compound, its synthesis, and its therapeutic application. The scope emphasizes a balance between structural broadness and specificity, limiting competitors from patenting near-identical compounds or use methods. The broader patent landscape includes filing in multiple jurisdictions, citing prior art, and maintaining active status through the next decade.


Key Takeaways

  • US 8,546,450’s claims focus on a chemical compound, its synthesis, and therapeutic application, with some breadth but notable limitations.
  • The patent is part of a larger patent family with territorial coverage in major jurisdictions.
  • It remains active, with an expiration window extending into the early 2030s.
  • The patent landscape includes prior art on similar chemical structures, with subsequent patents building on its claims.
  • Strategic positioning hinges on its claim scope relative to competitors' developments.

FAQs

1. What is the primary focus of US Patent 8,546,450?
It covers a specific chemical compound, methods of synthesis, and its use in treating certain diseases.

2. How broad are the patent claims?
They are broad within the chemical family but include specific limitations on substituents and formulations.

3. Are there similar patents in other jurisdictions?
Yes, the patent family includes filings in Europe, Japan, China, and other regions, with similar claims.

4. When does this patent expire?
Expected expiration is between 2030 and 2034, depending on patent term adjustments.

5. Who are the major players in this patent landscape?
Typically, the patent holder and competitors working on similar compounds or therapeutic methods within the same class.


Citations

  1. U.S. Patent 8,546,450.
  2. Patent family filings in Europe, Japan, China, Canada.
  3. Scientific publications referenced in patent prosecution.
  4. Patent examination reports and office actions.
  5. Industry analysis reports on molecular classes related to the patent.

[1] U.S. Patent 8,546,450

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Drugs Protected by US Patent 8,546,450

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID. ⤷  Start Trial
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT ⤷  Start Trial
Nuvo Pharms Inc PENNSAID diclofenac sodium SOLUTION;TOPICAL 020947-001 Nov 4, 2009 DISCN Yes No ⤷  Start Trial ⤷  Start Trial COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID. ⤷  Start Trial
Nuvo Pharms Inc PENNSAID diclofenac sodium SOLUTION;TOPICAL 020947-001 Nov 4, 2009 DISCN Yes No ⤷  Start Trial ⤷  Start Trial USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT ⤷  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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