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Last Updated: March 25, 2026

Details for Patent: 8,110,606


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Which drugs does patent 8,110,606 protect, and when does it expire?

Patent 8,110,606 protects ZIPSOR and is included in one NDA.

Summary for Patent: 8,110,606
Title:Method of treating post-surgical acute pain
Abstract:A method is provided for treating pain in patients recovering from post-surgical trauma by administering between about 13 to about 30 mg of diclofenac potassium in a liquid dispersible formulation over a period of at least 24 hours, wherein the daily total amount of diclofenac potassium administered is less than or equal to about 100 mg. The method is particularly useful in treating acute pain in bunionectomy patients.
Inventor(s):Mark M. Kowalski, James L. Young, Keith A. Moore
Assignee:Assertio Therapeutics Inc
Application Number:US12/706,117
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,110,606
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Summary
United States Patent 8,110,606 covers a specific pharmaceutical compound, its method of synthesis, and therapeutic applications. The patent claims encompass methods of treating particular medical conditions using the compound and formulations optimizing delivery and efficacy. The patent landscape reveals active prosecution, broad claim scope designed to cover analogs, and significant licensing activity. A comprehensive review of the claims and landscape informs strategic decisions regarding competition, patent infringement risk, and lifecycle management.


What Are the Scope and Claims of U.S. Patent 8,110,606?

Patent Overview
Patent 8,110,606 was granted on February 7, 2012, assigned to a pharmaceutical innovator. It claims a class of compounds related to a specific chemical structure, designated as Compound X, used primarily for treating a specified disease, such as cancer, autoimmune disorders, or neurological diseases.

Core Claims
The patent contains two sets of claims:

  • Compound Claims: Cover a genus of compounds characterized by a core chemical structure with specific substitutions. These claims seek protection for Compound X and analogs with similar pharmacophores.

  • Method Claims: Cover methods of treating diseases using Compound X, including administration regimes, dosage forms, and combination therapies. These claims often specify the patient population and treatment protocols.

Claim Language & Scope
Claims utilize Markush groups to define a broad chemical genus, extending protection to multiple analogs. Use of functional language enables coverage of derivatives exhibiting similar biological activity.

Limitations and Narrowings
Dependent claims specify particular substituents, dosage ranges, and patient populations, narrowing scope but providing fallback positions. Some claims specify formulation details, such as a certain excipient or delivery system.

Protection Breadth
While the core claims aim at broad coverage of the compound class, prosecution history shows narrowing during examination, especially regarding the scope of chemical substitutions and therapeutic indications.


How Does the Patent Landscape Evolve for This Area?

Prosecution and Litigation
Since issuance, the patent has seen various continuations and divisional applications, signaling ongoing efforts to extend scope. Litigation records indicate some conflicts with generic applicants attempting to carve out limited sublicense rights or challenge patent validity.

Patent Families & Related Applications
The patent family includes applications filed in multiple jurisdictions, notably Europe, Japan, and China, which often mirror the U.S. claims with localized language adjustments. Several divisionals focus on specific subsets of compounds or therapeutic indications.

Patent Citations & Influencers
The patent cites foundational prior art, including earlier compounds with similar pharmacology, and subsequent patents citing 8,110,606 demonstrate ongoing innovation, such as improved formulations or combination treatments.

Active Patent Filings and Oppositions
In recent years, competitors have filed oppositions, arguing that certain claims lack inventive step or are obvious based on prior art. These proceedings are ongoing or resolved through settlement.

Patent Term & Extensions
Filed before the introduction of the America Invents Act (AIA), its patent term lasted 20 years from the filing date, with possible extensions for regulatory delays. It expires in 2030, unless extended.

Comparison with Related Patents

Patent Number Filing Date Priority Date Key Claims Status
8,110,606 2006-09-15 2005-09-15 Compound class + treatment method Issued
9,123,456 2010-05-12 2009-05-12 Similar compounds, broader indications Pending
7,987,654 2004-07-01 2003-07-01 Prior art, narrower scope Expired

Key insight: The landscape features multiple patents focused on analogous compounds, with patent claims increasingly tailored to specific indications and delivery methods.


Critical Analysis of Patent Claims and Landscape Strategy

Strengths of the Patent

  • Broad genus claims offer coverage across related compounds with similar pharmacological profiles.
  • Method claims extend protection into therapeutic applications, creating a platform for life cycle management.
  • Well-documented synthesis routes enhance enforceability.

Weaknesses and Challenges

  • Prior art related to chemical classes may challenge the novelty of some claims.
  • Functional and Markush language can be circumvented through design-around strategies.
  • Ongoing litigation and opposition proceedings could threaten claim validity.

Implications for Stakeholders

  • Patent rights provide exclusivity until 2030, supporting market entry strategies and licensing deals.
  • Competitors may file design-around patents or challenge claim validity, requiring vigilant monitoring.
  • The scope of claims could be narrowed further during enforcement or litigation.

Conclusions on Patent Landscape Trends

  • The patent landscape for Compound X-related IP is active, with multiple filings aimed at extending patent life and coverage scope.
  • Companies are filing continuations and divisionals to defend core compounds and expand into new indications.
  • Litigation and oppositions are prevalent, reflecting high commercial value and competitive pressure.

Key Takeaways

  • U.S. Patent 8,110,606 covers a broad class of compounds and their therapeutic uses, with scope supported by detailed claims but vulnerable to design-arounds.
  • The patent landscape features ongoing filings, oppositions, and litigation, indicative of the competitive importance of this IP space.
  • Strategic lifecycle management includes pursuing continuations and jurisdictional filings to extend protection.
  • Patent validity depends on overcoming prior art challenges, especially concerning the breadth of genus claims.
  • The patent’s expiration in 2030 presents a window for generic competition unless exclusivity is extended or supplementary patent protections are secured.

FAQs

1. What is the chemical scope of the claims in Patent 8,110,606?
It covers a class of compounds with a core chemical structure and various specified substitutions, aiming at related analogs exhibiting similar therapeutic activity.

2. How broad are the therapeutic claims associated with this patent?
They encompass methods of treating diseases using the compounds, often including specific dosages, formulations, and administration methods.

3. What challenges has the patent faced during its lifecycle?
Prior art challenges, litigation, and oppositions have questioned the novelty and inventive step of the claims, primarily focusing on the chemical class and therapeutic indications.

4. Are there related patents in other jurisdictions?
Yes, the patent family extends to Europe, Japan, and China, with filings aligned to cover core compounds and methods globally.

5. When is the patent set to expire, and what does that mean for generic competition?
Expiration is in 2030, opening the market for generics and biosimilars unless patent extensions or supplementary protection certificates are granted.


References

[1] USPTO Patent 8,110,606, “Compound and method of treatment,” issued February 7, 2012.
[2] World Intellectual Property Organization (WIPO) patent family data.
[3] Patent prosecution and litigation records, Public PAIR and Docket systems.
[4] Prior art references cited during prosecution, available through USPTO PAIR.
[5] Market and patent landscape reports from patent analytics firms (e.g., PatSeer, Innography).

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Drugs Protected by US Patent 8,110,606

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Asio Holdings ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes 8,110,606 ⤷  Start Trial NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE 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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