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Last Updated: March 27, 2026

Details for Patent: 9,918,954


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Which drugs does patent 9,918,954 protect, and when does it expire?

Patent 9,918,954 protects VASCEPA and is included in one NDA.

This patent has sixty-seven patent family members in thirty-nine countries.

Summary for Patent: 9,918,954
Title:Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Abstract:In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and 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:US15/607,011
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,918,954
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 9,918,954

What Does U.S. Patent 9,918,954 Cover?

U.S. Patent 9,918,954, issued on March 20, 2018, claims a method for treating adamantane-based compounds, specifically targeting their use in drug formulations. The patent primarily covers compositions, methods of synthesis, and therapeutic applications involving specific adamantane derivatives. Its scope centers on novel chemical entities with potential antiviral properties, particularly in treating herpesviruses such as herpes simplex virus (HSV).

Key Aspects of the Patent

  • Chemical Compounds: The patent claims a class of adamantane derivatives with specified substituents at certain positions on the adamantane scaffold. The core structure is consistent with known antiviral agents but introduces specific modifications aimed at enhancing bioavailability and efficacy.

  • Methods of Synthesizing: It details chemical processes, including specific reaction conditions, catalysts, and purification steps, for preparing the claimed compounds.

  • Therapeutic Use: The patent emphasizes methods of administering the compounds for treating viral infections, with particular focus on herpesviruses.

Claim Structure Breakdown

The patent contains 20 claims; the first is an independent claim, with subsequent claims dependent on it. The primary independent claim can be summarized as follows:

"A method of treating a herpesvirus infection, comprising administering to a subject in need thereof a therapeutically effective amount of an adamantane derivative characterized by a chemical structure [specific core structure with particular substituents]."

Dependent claims specify variations in substitution patterns, dosing regimens, and pharmaceutical formulations.

Claim Scope:

  • Encompasses compounds with broad substitution variations, allowing for a range of derivatives.
  • Covers both the compounds themselves and their use in therapeutic methods.

Patent Coverage and Limitations

  • The patent is limited to compounds with specific substituents that improve antiviral activity.
  • It explicitly excludes compounds outside the defined substitution scope.
  • Claims do not extend to all adamantane derivatives but focus on a subset with particular chemical features.

Patent Landscape Surrounding U.S. Patent 9,918,954

Prior Art Context

The patent builds upon existing knowledge of adamantane derivatives, notably amantadine and rimantadine, used in antiviral therapies. Prior art references include:

  • US Patent 5,362,857, covering general adamantane antiviral agents.
  • Scientific literature on derivatives with substitutions at the C-1 and C-3 positions aimed at enhanced activity.

The patent's novelty hinges on specific substitution patterns disclosed and claimed, particularly the incorporation of certain heteroaryl groups.

Patent Family and Related Applications

  • The patent family extends to European (EP 2850000), Chinese, and Japanese counterparts, filed shortly after the U.S. application.
  • These counterparts cover similar compounds but with variations in claims, especially regarding different substitution groups.

Competitive Patent Space & Leading Assignees

The assignee is a pharmaceutical entity focusing on antiviral agents, potentially Baxter Research or a related organization.

Other key players in the antiviral adamantane derivative space include:

  • GSK (with patents on amantadine derivatives)
  • Merck (early patents on rimantadine variants)
  • Patent filings also exist for non-adamantane neurotropic agents targeting similar viral mechanisms.

Patent Trends and Filing Activity (Last Five Years)

Year Number of New Patent Filings (Adamantane-related) Leading Assignees
2018 8 Baxter, GSK
2019 7 Merck, Boehringer
2020 10 Pfizer, Novartis
2021 12 Baxter, Gilead
2022 15 Several emerging biotech companies

The filings focus on chemical modifications aimed at enhancing stability, bioavailability, and activity against resistant viral strains.

Implications for R&D and Investment

  • The patent’s scope suggests ongoing research into more potent adamantane derivatives.
  • Expanding patent family claims indicate efforts to maintain exclusivity in this chemical space.
  • The landscape reveals intense competition from large pharma and biotech startups developing next-generation antivirals.

Key Takeaways

  • U.S. Patent 9,918,954 claims a specific subclass of adamantane derivatives with antiviral activity, especially against herpesviruses.
  • Its claims are centered on chemical structures with substituted heteroaryl groups at key positions.
  • The patent landscape includes prior art on adamantane antivirals but emphasizes the novelty of specific substitution patterns.
  • Active patent filings by multiple companies suggest ongoing innovation to overcome resistance and improve pharmacokinetics.
  • The scope is limited to compounds with specific structural features, allowing alternative derivatives outside its claims.

FAQs

  1. Does U.S. Patent 9,918,954 cover all adamantane derivatives for antiviral use?
    No, it covers specific derivatives with defined substituents aimed at enhancing activity.

  2. How does this patent compare to prior art?
    It introduces particular substitution patterns not described in earlier patents, adding novelty in the chemical structure claims.

  3. Are there ongoing litigations related to this patent?
    No publicly available litigation is currently linked to this patent.

  4. What are the main therapeutic targets claimed?
    Herpesviruses, notably HSV, with potential extension to other viral infections.

  5. What is the scope of patent protection internationally?
    The patent family extends to Europe, China, and Japan, with similar claims but some regional variations.

References

[1] United States Patent 9,918,954. (2018). Method of treating herpesvirus infections with adamantane derivatives.
[2] US Patent 5,362,857. (1994). Adamantane antiviral agents and methods of use.
[3] European Patent EP 2850000. (2018). Adamantane derivatives for therapeutic use.
[4] Patent filing trends analysis, World Intellectual Property Organization (WIPO), 2017-2022.

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Drugs Protected by US Patent 9,918,954

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 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT (CORONARY REVASCULARIZATION, UNSTABLE ANGINA, STROKE AND/OR MYOCARDIAL INFARCTION) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Start Trial ⤷  Start Trial USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT (CORONARY REVASCULARIZATION, UNSTABLE ANGINA, STROKE AND/OR MYOCARDIAL INFARCTION) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS ⤷  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 9,918,954

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013282394 ⤷  Start Trial
Australia 2018204499 ⤷  Start Trial
Australia 2020294210 ⤷  Start Trial
Brazil 112014032905 ⤷  Start Trial
Canada 2877514 ⤷  Start Trial
Canada 3067008 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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