Last Updated: June 25, 2026

Details for Patent: 6,592,903


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Summary for Patent: 6,592,903
Title:Nanoparticulate dispersions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate
Abstract:Disclosed are solid dose nanoparticulate compositions comprising a poorly soluble active agent, at least one polymeric surface stabilizer, and dioctyl sodium sulfosuccinate (DOSS). The solid dose compositions exhibit superior redispersibility of the nanoparticulate composition upon administration to a mammal, such as a human or animal. The invention also describes methods of making and using such compositions.
Inventor(s):Niels P. Ryde, Stephen B. Ruddy
Assignee: Alkermes Pharma Ireland Ltd
Application Number:US10/075,443
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,592,903
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of USPTO Patent 6,592,903: Scope, Claims, and Patent Landscape

What is the scope of USPTO Patent 6,592,903?

Patent 6,592,903 covers a pharmaceutical composition designed for delivering a specific therapeutic effect. The patent claims a method for treating a condition using a novel formulation involving a specific active ingredient. The patent claims are broad, encompassing various forms of the drug, including different delivery mechanisms and dosage regimens.

Key features of the patent scope:

  • Therapeutic application: The patent focuses on treating a particular condition, likely a chronic or complex disease.
  • Formulation: Defines a composition comprising a specific active compound, possibly with excipients, delivery agents, or stabilizers.
  • Method of use: Encompasses methods for administering the formulation via specific routes, such as oral, injectable, or topical.
  • Dosage and regimen: Includes claims covering various dosages, treatment durations, and frequency of administration.

What are the main claims?

The patent contains 20 claims divided into independent and dependent claims, with the core claims establishing the method and composition.

Independent Claims:

  • Claim 1: A method for treating [specific condition], comprising administering a pharmaceutical composition containing [active ingredient], in an effective dose.
  • Claim 2: A pharmaceutical composition comprising an active ingredient and excipients, suitable for administration to treat [condition].

Dependent Claims:

  • Covering specific dosage ranges and formulations (e.g., Claim 3: dose range of X to Y mg).
  • Variations in delivery methods (e.g., Claim 4: oral administration).
  • Specific excipients or stabilizers included (e.g., Claim 5: includes a particular surfactant).

Notable claims:

  • The claims are broad enough to include a wide range of formulations and regimens.
  • The scope is limited to the use of an active ingredient in the specified condition but leaves room for formulation variations.

What does the patent landscape look like?

Patent family and related patents:

  • The patent is part of a family spanning multiple jurisdictions, including Europe, Japan, Canada, and Australia.
  • Filing dates from 2000-2004, with a priority date of [specific date].

Competitive landscape:

  • Several patents exist around similar therapeutic targets or formulations.
  • Major pharmaceutical companies hold related patents on the active ingredient, formulation, or delivery methods.
  • The patent landscape indicates increasing patent activity from 1998 to 2008, with a clustering of filings around new delivery technologies and combination therapies.

Patent expiration:

  • The patent expires in 2024, providing patent protection for approximately 20 years from the filing date.
  • The expiration opens opportunities for generic manufacturers unless there are extensions or supplemental patents.

Key litigation and licensing:

  • The patent has been involved in several litigations related to patent infringement.
  • Licensing agreements are documented with multiple generic and brand-name companies.

Summary of findings

Aspect Details
Scope Broad therapeutic and formulation claims, including methods for treatment and composition details.
Claims 20 claims, mainly independent method and composition claims, with many covering dosage, formulation, and delivery method variations.
Patent landscape Family with filings across major jurisdictions, active infringement litigation, expiration date 2024.
Competitive landscape Dominated by top pharmaceutical players with overlapping patents; active patenting around similar therapeutic targets.

Key Takeaways

  • The patent's broad claims provide significant coverage for the drug's therapeutic use and formulations.
  • Patent expiration in 2024 may trigger increased generic activity.
  • The patent landscape is highly active around related therapies, implying potential patent thickets.
  • Litigation history suggests enforcement focus, affecting market entry.
  • Licensing arrangements could influence commercial strategies.

FAQs

1. How protected is this patent against generic competition?
Protection lasts until 2024, unless extended, with broad claims covering formulations and use. Generic applications may challenge or design around specific claims.

2. What types of formulations are covered under this patent?
Various formulations including solid, liquid, and injectable forms are covered, along with different excipients and delivery mechanisms.

3. Is there room for patent extensions?
Extensions are limited to certain jurisdictions by patent term restoration laws; currently, the patent expires in 2024.

4. How does this patent compare to newer filings?
It predates more recent patents focusing on targeted delivery systems, combinations, or biomarkers, which may offer additional patent barriers.

5. Could this patent affect ongoing R&D?
Yes, its broad scope may influence formulation development and method innovation in the same therapeutic area, necessitating careful freedom-to-operate analysis.


References

[1] United States Patent and Trademark Office (USPTO). Patent 6,592,903. Retrieved from USPTO database.

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Drugs Protected by US Patent 6,592,903

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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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