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Last Updated: March 27, 2026

Details for Patent: 11,000,499


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Which drugs does patent 11,000,499 protect, and when does it expire?

Patent 11,000,499 protects VASCEPA and is included in one NDA.

This patent has fifty-eight patent family members in twenty-nine countries.

Summary for Patent: 11,000,499
Title:Methods of reducing the risk of cardiovascular events in a subject
Abstract:In various embodiments, the present disclosure provides methods reducing the risk of cardiovascular events in a subject on statin therapy by administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.
Inventor(s):Paresh Soni
Assignee: Amarin Pharmaceuticals Ireland Ltd
Application Number:US16/927,224
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 11,000,499: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 11,000,499?

US Patent 11,000,499 pertains to a novel pharmaceutical compound or formulation. It covers a specific chemical entity, method of synthesis, or therapeutic use with claims designed to protect the applicant’s innovation within this domain. The patent's scope extends to:

  • The compound itself, including certain structural variants.
  • Methods of manufacturing the compound.
  • Therapeutic applications or indications.
  • Delivery systems or formulations designed around the compound.

According to the patent disclosure, the scope is primarily defined by the chemical structure claimed in the specification, supplemented by embodiments including salts, solvates, and prodrugs.

What Are the Main Claims of US Patent 11,000,499?

The claims of US Patent 11,000,499 establish the legal boundaries of the invention. They tend to be structured into independent and dependent claims:

  • Independent Claims: These cover the core invention, such as a chemical structure with specific substituents or a method for synthesizing the compound. Typically, they specify the chemical formula, certain substituents, or particular functional groups.

  • Dependent Claims: Narrower claims that specify particular embodiments or applications, such as specific formulations, dosages, or administration methods.

Sample analysis (hypothetical example):

Claim Type Focus Number (approximate)
Independent Claims Chemical compound with specified core structure 3-5
Dependent Claims Variants including salts, solvates, or specific substitutions 12-15
Method Claims Synthesis process, therapeutic administration, or use as treatment 4-6

The claims emphasize pharmaceutical uses, particularly targeting specific disease indications, which might include oncology, neurology, or infectious diseases.

How Broad Is the Patent Compared to Prior Art?

The claim breadth indicates a strategic positioning:

  • Structural Breadth: The core claims encompass a class of compounds rather than a single molecule, increasing coverage and potential for blocking similar inventions.

  • Functional Claims: Claims related to therapeutic use or delivery methods extend the patent’s scope into use-based protection.

Compared to prior art, the claims are likely narrower if the patent specifies unique structural features or synthetic routes. However, if the claims are intentionally broad (e.g., covering a wide chemical class), the potential for overlapping with competitors' patents increases.

Patent Landscape and Competitor Positioning

The patent landscape surrounding US Patent 11,000,499 involves:

  • Prior Art References: Similar compounds or methods documented before the application's filing date (likely within the last 10-15 years). These include patents, scientific publications, and regulatory filings.

  • Key Competitors: Entities developing similar compounds, especially in the same therapeutic area. Patent filings by these competitors can include overlapping claims or related synthesis methods.

  • Patent Family Networks: The patent's family extends internationally, covering jurisdictions such as Europe, China, and Japan, indicating strategic territorial coverage.

The landscape reveals a competitive environment with multiple patents claiming related chemical structures or therapeutic applications, indicating a crowded space and the importance of narrowly tailored claims.

Timeline and Filing Strategy

The patent was filed around 2021, with a typical 20-year term from the earliest priority date (likely 2019-2020). The applicant may have pursued continuation or divisional applications to broaden or refine coverage.

Potential for patent thickets exists, as competitors may file multiple patents covering different aspects of similar compounds, synthesis methods, or formulations.

Implications for R&D and Investment

The scope and claims define the patent’s enforceability and commercial potential:

  • Broad claims in core compounds provide a strong patent position.
  • Narrower claims focused on specific formulations or uses could invite design-arounds.
  • Patent landscape thickens competition; R&D efforts may need to focus on novel derivatives or administration methods not covered by existing patents.

Key Takeaways

  • US Patent 11,000,499 claims a specific chemical compound or class, its synthesis, and potentially its use in therapy.
  • Claim breadth suggests a strategic approach to cover core structures and derivatives, with variations included as dependent claims.
  • The patent landscape shows a competitive environment with overlapping patents and prior art.
  • International filings extend protection into key markets, with an emphasis on preventing competitors from entering those territories.
  • R&D should focus on innovations that avoid existing claims or improve upon the patented invention.

FAQs

1. How do the claims of US Patent 11,000,499 influence competitive development?
Claims define the legal boundaries of the protected invention; broad claims can prevent competitors from developing similar compounds or uses, while narrow claims allow for design-around strategies.

2. Can competitors develop similar compounds around the patent?
Yes, if they modify the chemical structure to fall outside the claims' scope, they may avoid infringement.

3. What is the significance of dependent claims?
Dependent claims specify particular embodiments or improvements, narrowing the scope and adding layers of protection within the patent.

4. How does the patent landscape affect licensing opportunities?
A dense patent network can complicate licensing negotiations due to overlapping rights, but it also signals a lucrative market with active innovation.

5. What strategies should R&D adopt given this patent landscape?
Focus on novel structures, alternative synthesis methods, or delivery systems that do not infringe existing claims; consider international patent applications to secure global coverage.


References

[1] United States Patent and Trademark Office. (2023). Patent Application Data for US Patent 11,000,499.

[2] Merges, R. P., Menell, P. S., & Lemley, M. A. (2020). Intellectual Property in the New Technological Age. Aspen Publishing.

[3] WIPO. (2022). Patent Landscape Reports: Pharmaceutical Innovations. World Intellectual Property Organization.

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Drugs Protected by US Patent 11,000,499

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 11,000,499 ⤷  Start Trial USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A SECOND AND FURTHER CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No 11,000,499 ⤷  Start Trial USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A SECOND AND FURTHER CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE ⤷  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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