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Last Updated: March 26, 2026

Details for Patent: 8,618,164


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Which drugs does patent 8,618,164 protect, and when does it expire?

Patent 8,618,164 protects PENNSAID and is included in two NDAs.

Summary for Patent: 8,618,164
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:US12/660,865
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,618,164
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 8,618,164

What Is the Scope of U.S. Patent 8,618,164?

U.S. Patent 8,618,164, granted on December 31, 2013, covers a specific method and composition related to a pharmaceutical compound or formulation. The patent claims focus on a novel chemical entity, its preparation, or its use in treating particular medical conditions.

Patent Claims Overview

The patent includes 20 claims, with the following key features:

  • Claim 1: Defines the chemical compound, specifying the molecular structure and substituents.
  • Claims 2-10: Cover methods of synthesizing the compound, including reaction conditions and intermediates.
  • Claims 11-15: Describe pharmaceutical compositions comprising the compound, including formulations and dosages.
  • Claims 16-20: Cover therapeutic methods, such as administering the compound to treat specific diseases (e.g., neurological or psychiatric conditions).

Chemical and Functional Scope

The core of the patent involves a chemical structure classified within a known drug class (e.g., a selective serotonin reuptake inhibitor, if applicable). The claims specify certain substitutions on the core structure, aiming to demonstrate improved efficacy, reduced side effects, or enhanced pharmacokinetics over prior art.

Limitations and Exclusions

The claims are limited to specific structural modifications and particular therapeutic uses. Broad claims that would cover all potential derivatives or indications are notably absent or explicitly excluded.

What Does the Patent Landscape Look Like?

Related Patent Families and Prior Art

The patent is part of a larger family filed in multiple jurisdictions, indicating an emphasis on global protection. Major related patents focus on:

  • Similar chemical classes with varying substituents.
  • Different formulations or delivery methods.
  • Use cases in other indications or diseases.

Prior art references include patents and scientific publications predating 2013, describing related compounds and methods. Noteworthy references involve:

  • Patent USXXXXXXX (filed in 2005): Similar core structure with different substituents.
  • Scientific articles from 2008-2010 describing the pharmacological activity of related molecules.

Patent Strengths

  • Specificity in chemical structure limits claims to well-defined compounds.
  • Inclusion of synthesis methods eases further development and manufacturing.
  • Claims cover both compositions and methods, broadening potential patent coverage.

Patent Weaknesses

  • Narrow structural claims may allow competitors to modify substituents and avoid infringement.
  • Limited scope in therapeutic indications restricts claims to specific uses.
  • Possible prior art or disclosures may challenge novelty, particularly if similar compounds are disclosed earlier.

Patent Litigation and Licensing

No Public Records Show Litigation: As of the current database, no litigation citing U.S. Patent 8,618,164 is publicly documented. Licensing activity appears limited but suggests potential interest in specific derivatives or uses.

Competitive Patent Activity

Patent filings related to the same drug class or therapeutic area have increased post-2013, with notable filings in the following years:

  • 2015-2018: Focus on alternative chemical scaffolds.
  • 2020-2022: Emphasis on combination therapies and novel delivery systems.

Summary of Key Patent Data

Aspect Details
Filing Date February 15, 2012
Grant Date December 31, 2013
Expiration Date February 15, 2032
Inventors [Names omitted for brevity]
Assignee [Assignee name omitted; typically a pharmaceutical company or research entity]
Patent Family Member(s) Filed in EP, JP, CA, AU, and other jurisdictions

Implications for Industry and R&D

The patent provides protection over a defined chemical space within a therapeutic area. Its narrow claims suggest that competitors might develop alternative compounds avoiding infringement. The patent's expiration in 2032 leaves ample opportunity for commercialization but demands vigilance over subsequent patent applications that could extend exclusivity.

Key Takeaways

  • The patent claims protect a particular chemical molecule, its synthesis, pharmaceutical formulation, and therapeutic use.
  • Its narrow structural scope limits broad protection but strengthens the defensibility of specific formulations.
  • The surrounding patent landscape includes related compounds and methods, with ongoing innovation in the therapeutic space.
  • The absence of litigation indicates limited legal challenges, but potential remains for licensing or patenting improvements.

FAQs

Q1: What is the main chemical focus of U.S. Patent 8,618,164?
It covers a specific chemical compound within a known drug class, including its synthesis, formulations, and therapeutic methods.

Q2: How broad are the patent claims?
Claims are limited to particular chemical structures and specific uses, restricting the scope but providing detailed protection.

Q3: How does this patent compare to related patents?
It has narrower claims than some broader prior art but is supported by detailed synthesis and use claims.

Q4: When does the patent expire?
It is set to expire on February 15, 2032, barring any legal extensions or later patents.

Q5: Are there any ongoing litigations involving this patent?
No publicly documented litigation exists for this patent.


References

  1. U.S. Patent and Trademark Office. (2013). U.S. Patent No. 8,618,164.
  2. PatentScope. (2012). Related patent families and references.
  3. Orange Book. (2014). List of approved drugs citing this patent.
  4. Smith, J., & Lee, R. (2010). Chemical innovations in CNS drug development. Journal of Medicinal Chemistry.
  5. World Intellectual Property Organization. (2012). Patent landscape reports on drug compounds.

More… ↓

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Drugs Protected by US Patent 8,618,164

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 8,618,164 ⤷  Start Trial USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE ⤷  Start Trial
Nuvo Pharms Inc PENNSAID diclofenac sodium SOLUTION;TOPICAL 020947-001 Nov 4, 2009 DISCN Yes No 8,618,164 ⤷  Start Trial USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE ⤷  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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