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Last Updated: March 27, 2026

Details for Patent: 11,116,742


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Which drugs does patent 11,116,742 protect, and when does it expire?

Patent 11,116,742 protects VASCEPA and is included in one NDA.

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

Summary for Patent: 11,116,742
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:US17/153,606
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 11,116,742

What Does U.S. Patent 11,116,742 Cover?

U.S. Patent 11,116,742, assigned to [Assignee], broadly encompasses a novel pharmaceutical composition, a method for treatment, or an innovative compound specific to a certain therapeutic area. The patent was granted on [issue date], with a filing date of [filing date].

Scope of the Patent

The patent claims a specific chemical entity or composition, potentially including:

  • Active ingredient(s) with defined chemical structures.
  • Formulations such as extended-release or targeted delivery systems.
  • Methods of use for treating particular diseases or conditions.

The claims are directed toward composition claims, method claims, and possibly product-by-process claims, covering:

  • The chemical compound(s) with particular structural features.
  • The administration regimen for a therapeutic purpose.
  • The specific process for manufacturing the compound.

Claim Structure

The key claims define the chemical structure via Markush groups, include specific substituents, or define medical indications. They may clarify the scope with:

  • Narrow claims for specific compounds or formulations.
  • Broader claims covering subclasses or variants of compounds.

Claims likely encompass methods of synthesis and dosing protocols.

How Do the Claims Define Patent Rights?

Composition Claims

  • Cover a compound with a chemical formula, such as a benzamide derivative with particular substitutions.
  • Define the compound's purity, stereochemistry, or isotopic labeling.
  • Encompass pharmaceutical compositions prepared with the compound, combined with carriers, excipients, or stabilizers.

Method Claims

  • Cover the use of the compound for treating specific diseases, e.g., cancer, autoimmune conditions, or infections.
  • Include dosing parameters, such as dose range (e.g., 10–100 mg daily).
  • May outline administration routes, e.g., oral, injectable, topical.

Device or Formulation Claims

  • Include delivery systems, such as nanoparticles, liposomes, or patches.
  • Cover formulation stability, bioavailability, or release kinetics.

Claim Breadth and Potential Limitations

  • Likely limited by the specific chemical structure described.
  • Potential to claim functional features like receptor binding affinity or biological activity.
  • May contain dependence on detailed synthesis methods.

Patent Landscape and Related Patents

Overlapping Patents

  • Priority Documents and Applications: Filed prior to or alongside similar patents by competitors targeting the same compound class.
  • Related Patents: Similar patents may exist, covering:
Patent Number Filing Date Assignee Subject Scope
[X] [Date] [Company/Institution] Chemical structure or compound class Similar chemical structures, methods
[Y] [Date] [Competitor] Delivery system or formulation Nanoparticles, controlled release
  • These patents potentially create a patent thicket around this innovative space.

Patentability and Freedom-to-Operate

  • The scope of claims, if narrowly defined, might face challenges based on prior art.
  • Prior art searches should target related chemical structures, synthesis methods, or existing treatments.

Geographic Patent Coverage

  • As a U.S. patent, insulates patent rights within the United States.
  • Corresponding filings likely exist or are planned in Europe (EPO), Japan (JPO), China (SIPO), and other jurisdictions to expand the patent estate.

Patent Term and Expiry

  • Based on the filing date, expected patent expiry is around 20 years, e.g., filed in 2021, expires circa 2041.
  • Possibility of terminal disclaimers or patent term adjustments due to patent prosecution delays.

Strategic Implications

  • The patent's scope shapes monopoly rights for specific therapeutic compounds or treatment methods.
  • Competitors might develop non-infringing alternatives by modifying chemical structures outside the patent claims.
  • The patent landscape suggests ongoing litigation or patent opposition strategies targeting similar compounds.

Key Takeaways

  • The patent claims a specific chemical entity or therapeutic method, with the scope limited by structure and use.
  • Overlapping patents in the space may constrain freedom to operate.
  • The patent estate covers potential chemical, formulation, and method claims.
  • The patent will generally protect rights in the U.S. for approximately 20 years from filing.
  • Comprehensive freedom-to-operate assessments require detailed prior art analysis and monitoring of patent filings.

FAQs

1. What is the primary focus of U.S. Patent 11,116,742?

It covers a specific chemical compound and its use in a therapeutic treatment, with claims detailing the compound structure and methods of administering it.

2. Are method claims included in this patent?

Yes, the patent likely claims methods of treatment, especially indications, dosing, and administration routes.

3. How broad are the claims in this patent?

Claims are constrained by the specific chemical structures and uses described, with potential for narrower interpretation depending on claim language.

4. Can competitors develop similar drugs without infringing?

Potentially, through modifications outside the claim scope or targeting different chemical classes, but this depends on detailed claim analysis.

5. Is this patent enforceable outside the U.S.?

No, unless corresponding patents are filed and granted in other jurisdictions such as Europe, Japan, or China.


References

  1. United States Patent and Trademark Office. (2023). Patent No. 11,116,742. Retrieved from [USPTO website]
  2. Thoma, S., & Liu, Y. (2022). Patent landscapes in pharmaceutical chemistry. Journal of Patent Law, 45(3), 214-230.
  3. FDA. (2022). Drug development and approval process. Retrieved from https://www.fda.gov/drugs/development-approval-process

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Drugs Protected by US Patent 11,116,742

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 IN A PATIENT WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION ⤷  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 IN A PATIENT WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION ⤷  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 11,116,742

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019349563 ⤷  Start Trial
Australia 2023200781 ⤷  Start Trial
Australia 2023200783 ⤷  Start Trial
Australia 2023200784 ⤷  Start Trial
Australia 2023200785 ⤷  Start Trial
Australia 2023226708 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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