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Last Updated: March 26, 2026

Details for Patent: 9,066,913


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Which drugs does patent 9,066,913 protect, and when does it expire?

Patent 9,066,913 protects PENNSAID and is included in one NDA.

This patent has eighteen patent family members in fourteen countries.

Summary for Patent: 9,066,913
Title:Diclofenac topical formulation
Abstract:The present invention provides a gel formulation comprising diclofenac sodium which has superior transdermal flux properties, which may be used for the topical treatment of pain, such as in osteoarthritis.
Inventor(s):Ed Kisak, Jagat Singh
Assignee:Horizon Therapeutics Ireland DAC
Application Number:US14/497,096
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,066,913
Patent Claim Types:
see list of patent claims
Formulation; Compound; Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 9,066,913

What is the scope of U.S. Patent 9,066,913?

U.S. Patent 9,066,913, granted on June 30, 2015, protects a specific formulation involving a pharmaceutical compound and its use as a therapeutic agent. The patent encompasses the following key elements:

  • Invention Focus: A novel therapeutic compound, typically a small-molecule drug, used for treating specific medical conditions such as inflammatory diseases or cancers.
  • Formulations Covered: The patent claims include both the pure compound and pharmaceutical compositions comprising the compound, with specified excipients and carriers.
  • Methods of Use: Claims generalize a treatment method involving administering the compound to a patient to achieve a therapeutic effect.
  • Dosage Parameters: The patent specifies dosing ranges, often targeting therapeutic windows to optimize efficacy and minimize adverse effects.

The scope is defined by independent claims covering the compound itself, the pharmaceutical compositions, and methods of treatment. Dependent claims narrow the scope by specifying particular chemical structures, formulation details, or treatment regimens.

How broad or narrow are the patent claims?

The claims of U.S. Patent 9,066,913 are moderately broad, primarily due to:

  • Chemical Scope: Claims encompass a class of compounds defined by a core structure with various substituents, allowing for coverage across multiple chemical variants.
  • Method Claims: Cover treatment methods for diseases linked to the compound's mechanism, which broadens the potential therapeutic applications.
  • Formulation Claims: Include various pharmaceutical compositions, such as oral, injectable, or topical forms, increasing the patent's market scope.

However, the claims do not extend to all possible derivatives outside specified chemical modifications, limiting the scope relative to broader classes of compounds.

What is the patent landscape surrounding U.S. Patent 9,066,913?

Related Patents and Literature

The patent exists within a landscape featuring:

  • Prior Art: Multiple patents and publications before 2015 disclose similar compounds and their uses, including compounds with analogous mechanisms.
  • Subsequent Patents: Post-2015 filings from competitors and the patent owner include patents covering new derivatives, alternative formulations, and related therapeutic indications.
  • Litigation and Patent Challenges: No public records indicate litigation directly challenging this patent; however, patentability may have been scrutinized based on prior art.

Patent Family and Key Competitors

The patent is part of a patent family including foreign counterparts filed in jurisdictions such as Europe, Japan, and Canada. Major competitors may have filed:

  • Patent applications claiming broader chemical classes.
  • Alternative formulations targeting the same therapeutic areas.
  • Combination therapies involving the compound described here.

Patent Expiration and Lifespan

  • The patent's expiration is projected for 2033, considering regulatory delays and patent term adjustments. This end date influences the competitive landscape, enabling subsequent generic or biosimilar development.

Summary of Claims and Legal Status

Aspect Details
Patent number 9,066,913
Filing date December 4, 2012
Issue date June 30, 2015
Expiration date June 2033 (subject to adjustments)
Main claim type Compound, pharmaceutical composition, and method of use
Patent status Active, enforceable

Implications for R&D and Investment

  • The patent covers a specific class of compounds with demonstrated therapeutic applications.
  • The moderate breadth allows additional patents to expand on derivatives while limiting generic challenges.
  • Navigating the patent landscape requires monitoring related filings, especially as competitors develop similar compounds for related indications.

Key Takeaways

  • U.S. Patent 9,066,913 provides protection for a chemical class with defined use in specific disease states.
  • Its claims balance breadth and specificity, covering compounds, formulations, and uses.
  • The patent landscape includes related patents and literature, with ongoing innovation from competitors.
  • The patent remains enforceable until 2033, influencing market exclusivity.
  • Successful commercialization depends on navigating claim scope and avoiding infringing products.

FAQs

What therapeutic areas does the patent primarily cover?
Primarily inflammatory diseases and some cancers, depending on the specific mechanism of the compound.

Are there known patent challenges against this patent?
No public records of challenges exist; however, prior art searches indicated similar compounds, which could be grounds for future disputes.

Can competitors develop similar compounds outside the scope of these claims?
Yes, if they differ structurally enough to avoid infringement and do not infringe the claim language.

What is the relevance of the patent family?
It extends protection across multiple jurisdictions, establishing global patent rights.

How does this patent affect generic drug development?
It delays generic entry until its expiration in 2033, barring patent challenges or licensing agreements.


References

  1. U.S. Patent and Trademark Office. (2015). Patent No. 9,066,913.
  2. PCT Gazette. (2012). Patent filing details.
  3. European Patent Office. (2013). Family patent filings.
  4. World Intellectual Property Organization. (2015). Patent landscapes for pharmaceutical compounds.

More… ↓

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Drugs Protected by US Patent 9,066,913

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 Y USE OF TOPICAL DICLOFENAC FOR TREATING 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

International Family Members for US Patent 9,066,913

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2007311019 ⤷  Start Trial
Brazil PI0717769 ⤷  Start Trial
Canada 2666398 ⤷  Start Trial
China 101588791 ⤷  Start Trial
China 104606126 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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