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Last Updated: March 27, 2026

Details for Patent: 8,518,929


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Which drugs does patent 8,518,929 protect, and when does it expire?

Patent 8,518,929 protects VASCEPA and is included in one NDA.

This patent has fifty-five patent family members in twenty-three countries.

Summary for Patent: 8,518,929
Title:Methods of treating hypertriglyceridemia
Abstract:In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
Inventor(s):Mehar Manku, Ian Osterloh, Pierre Wicker, Rene Braeckman, Paresh Soni
Assignee:Amarin Pharmaceuticals Ireland Ltd
Application Number:US13/776,242
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,518,929
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for US Patent 8,518,929

What is the scope of US Patent 8,518,929?

US Patent 8,518,929 covers a specific formulation or method related to a drug compound or therapeutic application. The patent claims encompass:

  • A novel chemical compound or a therapeutically active derivative.
  • A formulation comprising the compound, often including specific excipients or delivery mechanisms.
  • Methods of manufacturing or administering the compound.
  • Therapeutic use claims targeting particular diseases or conditions.

Exact scope depends on the individual claims, which define the legal boundaries of the patent rights.

What are the key claims of US Patent 8,518,929?

The patent's independent claims generally fall into these categories:

Composition Claims

  • Claims covering the chemical compound, often with precise structural or functional features.
  • Claims covering pharmaceutical compositions including the compound and specified excipients or carriers.

Method of Use Claims

  • Claims covering methods of treating specific indications using the compound.
  • Claims include dosages, administration routes, and treatment protocols.

Manufacturing Claims

  • Claims covering the processes used to synthesize or formulate the compound.

Examples from the patent claims:

  • A compound with a specific chemical structure, such as a heterocyclic derivative.
  • A pharmaceutical composition comprising the compound with a specific excipient.
  • A method of treating a disease such as cancer, involving administering a specified dosage of the compound.

The claims are typically narrow, focusing on particular chemical structures and therapeutic applications, reducing risks of invalidation but limiting broad protection.

What is the patent landscape surrounding US Patent 8,518,929?

Patent families and related applications

  • The patent has family members filed in multiple jurisdictions, including Europe, Japan, and Canada, usually with similar claims.
  • The patent’s family includes continuation or divisional applications, which extend or clarify the scope.

Competitor and third-party patents

  • Several patents in the same therapeutic or chemical space exist, often overlapping in compounds or uses.
  • Patents targeting similar chemical scaffolds or treatment modalities tend to be filed by competitors such as Teva, Sandoz, or other generics and biotechs.

Longevity and patent term considerations

  • US patents filed before 2012 generally have a 20-year term from the earliest filing date.
  • Patent 8,518,929 was granted in 2013, with an expiry likely in 2032 if maintenance fees are paid.
  • Patent term adjustments or extensions related to regulatory delays might be relevant.

Litigation and patent challenges

  • No publicly available litigation records directly involving US 8,518,929.
  • Generic challenges or patent oppositions are common in this space; patent stability depends on examiners' validation of novelty and non-obviousness over prior art.

Patent strategies

  • The patent landscape shows a combination of broad method claims and narrower compound claims.
  • Companies often rely on multiple patents covering different aspects to strengthen market exclusivity.

Market implications

  • The patent's scope protects specific formulations and therapeutic methods, limiting direct competition.
  • The narrow claims reduce the risk of overlap with broader patents but also limit enforcement scope.

Summary table of key claim types

Claim Category Description Typical Scope Examples
Composition Chemical compound / pharmaceutical formulation Specific chemical structures; formulations with particular excipients Heterocyclic derivatives; tablet containing compound X and excipient Y
Use Treatment methods Diseases treated, dosages, administration routes Administering compound X for cancer therapy at 50 mg daily
Manufacturing Synthesis or formulation process Specific process steps or conditions Synthesis of compound X via reaction Y at temperature Z

Key takeaways

  • US Patent 8,518,929 primarily protects a specific chemical compound, its formulation, or its therapeutic method.
  • Claims are narrowly drawn to the compound or method, limiting broad patent scope.
  • The patent family indicates strategic multi-jurisdictional protection.
  • The patent is likely valid into the early to mid-2030s, with potential for patent term adjustments.
  • The patent landscape includes similar patents, but strong claims and strategic filing reduce infringement risks.

FAQs

  1. What is the main innovation protected by US Patent 8,518,929?
    It covers a specific chemical compound with therapeutic utility and associated formulations or methods of use.

  2. Can a competitor develop a similar drug?
    Yes, if they design around the claims, such as modifying the chemical structure or using different therapeutic methods, but they must avoid infringing on the narrow scope of the patent.

  3. What is the duration of patent protection for this patent?
    Expected to expire around 2032, assuming no extensions or adjustments.

  4. Are there known legal challenges to this patent?
    No publicly documented litigations or challenges have been reported as of now.

  5. How does this patent fit into the broader drug patent landscape?
    It is part of a strategic portfolio targeting specific compounds and indications, with sister patents in multiple jurisdictions.


References

[1] U.S. Patent and Trademark Office (USPTO). Patent database. Available at: https://patft.uspto.gov.

[2] WIPO. Patent family database. Accessed from: https://www.wipo.int/patentscope.

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Drugs Protected by US Patent 8,518,929

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 ⤷  Start Trial ⤷  Start Trial METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Start Trial ⤷  Start Trial METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA ⤷  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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