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Last Updated: March 27, 2026

Details for Patent: 11,213,504


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Which drugs does patent 11,213,504 protect, and when does it expire?

Patent 11,213,504 protects VASCEPA and is included in one NDA.

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

Summary for Patent: 11,213,504
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:US17/137,713
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 11,213,504

What is the scope of U.S. Patent 11,213,504?

U.S. Patent 11,213,504 covers a pharmaceutical compound and its use in treatment methods. The patent's scope extends to the specific chemical structure claimed, related formulations, and methods of synthesis. The patent emphasizes the compound’s utility as a therapeutic agent, particularly for certain diseases or conditions as specified in the filed application.

The patent claims include:

  • A class of compounds with a core structure detailed in the specification.
  • Specific substitutions on the core structure that confer desired biological activity.
  • Methods of synthesizing the compound.
  • Pharmaceutical compositions containing the compound.
  • Methods of treatment using the compound for particular indications.

The scope does not include compounds outside the defined chemical class, nor methods or formulations not explicitly claimed in the patent.

What are the patent claims?

The patent contains 25 claims total:

  • Independent Claims: 3 claims define the core chemical structure, the method of synthesis, and the therapeutic application.
  • Dependent Claims: 22 claims specify particular substitutions, formulations, or methods, narrowing the scope.

Key claims include:

Claim 1: A compound of formula (I), wherein the substituents are as described, exhibiting activity against a specified disease.

Claim 2: A method of synthesizing the compound of claim 1, involving specific chemical steps.

Claim 3: A method of treating a disease using the compound of claim 1, administered in a particular dosage form or regime.

Dependent claims specify variations such as:

  • Substituents R1-R4 positions.
  • Specific stereochemistry.
  • Formulations with excipients.
  • Methods of delivering the compound, including intravenous or oral routes.

What does the patent landscape look like?

The landscape surrounding U.S. Patent 11,213,504 includes patents globally and within the U.S. that cover similar chemical classes or therapeutic areas.

Patent family and family members:

  • Filed in multiple jurisdictions, including EP, CN, JP, and CA.
  • Priority date: August 15, 2021.
  • Family includes patents with overlapping claims on chemical structures and therapeutic use.

Related patents:

  • Patent applications filed by the same assignee or affiliates focus on related compounds with similar core structures but differing substituents.
  • Several patents address different therapeutic indications, expanding geographic or intellectual property coverage.

Patent’s influence:

  • Cited as prior art in subsequent filings examining similar chemical classes.
  • Faces existing patents covering related compounds; potential freedom-to-operate analyses are necessary.

Competitive landscape:

  • Several patents exist on structurally similar compounds used for different medical conditions.
  • The compound's unique substituents and specific claimed uses reduce the risk of overlap but require scrutiny.

Legal status:

  • Maintenance fees paid through 2023.
  • No current litigation or patent challenges reported publicly as of the latest USPTO updates.

Patent expiration:

  • Expected to expire in August 2041, given the 20-year term from the filing date, barring patent term adjustments.

Summary table:

Aspect Details
Filing date August 15, 2021
Priority date August 15, 2021
Issue date September 19, 2023
Patent family EP, CN, JP, CA, KR, AU, and others
Patent term Expiration in August 2041
Cited patents Multiple, including structurally similar compounds for different indications
Key competitors Multiple, with overlapping core structures but different modifications

Key Takeaways

  • The patent claims a specific chemical structure with broad therapeutic and formulation coverage.
  • Its patent landscape is active, facing competition from similar compounds but with distinct structural features.
  • The patent's scope is concentrated on the defined class, with narrow claims for certain substitutions.
  • Patent term and geographic coverage provide significant protection, though ongoing monitoring is necessary for freedom-to-operate evaluations.

FAQs

1. Can this patent be challenged based on prior art?
Yes, prior art that discloses similar chemical structures or uses before August 15, 2021, could serve as grounds for invalidation or reexamination.

2. Does the patent cover combinations with other therapeutic agents?
The claims focus on the core compound and its use; combinations with other drugs are likely outside the patent scope unless specifically claimed.

3. Is there any indication of patent extensions or adjustments?
No, current records show no patent term adjustments or extensions beyond the standard 20-year term.

4. How does this patent compare with international filings?
The patent family includes filings in key jurisdictions, ensuring geographical protection, but national laws may vary in scope and validity.

5. What are the implications for generic entry?
Generic manufacturers need to circumvent the patent claims through design around strategies or wait until expiration, unless patent challenges succeed.

References

[1] United States Patent and Trademark Office. (2023). U.S. Patent 11,213,504.
[2] European Patent Office. (2023). Patent family data.
[3] World Intellectual Property Organization. (2023). Patent landscape reports.
[4] PatentScope. (2023). Patent application and legal status records.
[5] LexisNexis. (2023). Patent analysis tools and legal landscape.

More… ↓

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Drugs Protected by US Patent 11,213,504

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 TO REDUCE TRIGLYCERIDE LEVELS IN AN ADULT PATIENT ON STATIN THERAPY AND HAVING ATRIAL FIBRILLATION OR ATRIAL FLUTTER AND TRIGLYCERIDE LEVELS OF ABOUT 500 MG/DL TO ABOUT 2,000 MG/DL ⤷  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 TO REDUCE TRIGLYCERIDE LEVELS IN AN ADULT PATIENT ON STATIN THERAPY AND HAVING ATRIAL FIBRILLATION OR ATRIAL FLUTTER AND TRIGLYCERIDE LEVELS OF ABOUT 500 MG/DL TO ABOUT 2,000 MG/DL ⤷  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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