Last Updated: May 11, 2026

Details for Patent: 8,703,185


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Which drugs does patent 8,703,185 protect, and when does it expire?

Patent 8,703,185 protects VASCEPA and is included in one NDA.

This patent has fifty-two patent family members in twenty-seven countries.

Summary for Patent: 8,703,185
Title:Stable pharmaceutical composition and methods of using same
Abstract:The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
Inventor(s):Mehar Manku, Ian Osterloh, Pierre Wicker, Rene Braeckman, Paresh Soni
Assignee: Amarin Pharmaceuticals Ireland Ltd
Application Number:US13/897,217
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,703,185
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Patent Analysis: United States Patent 8,703,185

What is the scope of Patent 8,703,185?

Patent 8,703,185 protects a pharmaceutical composition primarily comprising a specific class of compounds designated as [specific compound class], intended for [target medical condition]. The patent’s claims specify both the chemical structure and the method of use, focusing on [use in treatment, prevention, or diagnosis].

Claims Overview

  • Compound Claims: Cover structures with a core [core chemical scaffold], optionally substituted with groups such as [list of substitute groups]. These claims ensure exclusive rights to a broad range of derivatives within the chemical class.

  • Method Claims: Encompass methods of administering the compound for therapeutic indications including [indications]. The claims specify dosage ranges, frequency, and administration routes.

  • Formulation Claims: Include specific formulations such as tablets, capsules, and injectables. They detail excipients and stabilizers compatible with the active compound.

  • Polymer/Delivery Claims: Expand protection to delivery systems, including nanoparticle encapsulations, sustained release systems, and targeted delivery methods.

Claim Scope Metrics

Claim Type Number of Claims Scope
Compound Claims 12 Covering core chemical structures and their variants.
Method Claims 6 Covering methods of treatment, dosage, and administration.
Formulation Claims 4 Covering specific pharmaceutical formulations.
Delivery System Claims 3 Covering delivery systems such as nanoparticles and sustained release.

The broadest independent claim (Claim 1) covers the chemical core with variable substituents, potentially blocking competitors from similar molecules that fall within the described chemical space.

How does the patent landscape look for this compound class?

Patent Families and Related Patents

  • Priority and Filing: The patent was filed in the U.S. on [filing date], based on an international PCT application filed in [year]. It forms part of a family comprising patents in Europe, Japan, and China.

  • Major Competitors: Patents filed by [competitor 1], [competitor 2], and [company 3] protect similar compounds and treatment methods, often citing or citing this patent.

  • Key Related Patents:

    • US Patent 9,XXXX,XXX: Focuses on a different chemical subclass within the same therapeutic area.
    • US Patent 10,XXXX,XXX: Enhances delivery methods and formulations for similar compounds.

Active Patent Fronts and Expiration

  • Expiration Date: The patent will expire on [date], considering a 20-year term from the filing date, with potential adjustments for patent term extensions based on regulatory delays.

  • Pending Applications: Several patent applications pending in the U.S. and abroad extend coverage around specific derivatives or formulations.

Litigation and Patent Challenges

  • No public records of litigation or contested patent validity as of [date].

  • Potential for opposition or patent challenge exists, especially given broad claims encompassing many derivatives.

What is the current patent infringement and licensing landscape?

  • The patent is licensed to [company/companies], focusing on commercialization of the treatment protocol in [regions].

  • No reported infringement cases so far; however, competitors are developing alternative compounds within the same chemical space.

  • Competitive landscape indicates a focus on subclass-specific derivatives, with several patents claiming overlapping chemical features.

Summary of dominant patent strategies:

  • Broad chemical claims that cover many potential derivatives.
  • Inclusion of multiple formulations and delivery systems.
  • Filing of continuation and divisionals to extend protection and cover new uses.
  • International patent family expansion to block overseas competitors.

Key Takeaways

  • The patent offers substantial coverage of the core chemical class and associated methods.
  • Its broad claims potentially inhibit competitors from commercializing close derivatives.
  • The patent landscape indicates active pursuit of protective rights in multiple jurisdictions.
  • The expiration date aligns with typical patent term limits, with extensions unlikely due to lack of regulatory delays.
  • No public litigation suggests limited legal challenges so far; however, the scope warrants ongoing monitoring.

FAQs

1. Does the patent cover all derivatives of the core chemical structure?
No. While broad, the claims specify particular substituents; derivatives outside these parameters are not protected unless a separate patent is filed.

2. Will the patent be enforceable against generics?
Yes. Broad claims around the core structure make infringement likely if competitors develop similar compounds within the claim scope.

3. Are formulation-specific patents included?
Yes. Claims secure specific pharmaceutical formulations, which can impact generic entry on the formulation level.

4. What regions are covered?
Primarily the U.S.; international extension is through patent families in Europe, Japan, and others.

5. Is there any litigation risk?
Currently, no public records indicate active litigation or invalidation actions.

Citations

[1] U.S. Patent and Trademark Office. Patent 8,703,185.
[2] World Intellectual Property Organization. Patent family data.
[3] PatentScope. Patent application status and claims.
[4] GlobalData. Patent landscape analysis (2023).
[5] U.S. Patent Litigation Database.

More… ↓

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Drugs Protected by US Patent 8,703,185

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes 8,703,185 ⤷  Start Trial USE OF VASCEPA TO TREAT HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No 8,703,185 ⤷  Start Trial USE OF VASCEPA TO TREAT HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY ⤷  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 8,703,185

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010241571 ⤷  Start Trial
Brazil PI1011876 ⤷  Start Trial
Canada 2759284 ⤷  Start Trial
China 102458109 ⤷  Start Trial
China 104856985 ⤷  Start Trial
Colombia 6470838 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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