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Last Updated: March 27, 2026

Details for Patent: 8,546,372


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Which drugs does patent 8,546,372 protect, and when does it expire?

Patent 8,546,372 protects VASCEPA and is included in one NDA.

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

Summary for Patent: 8,546,372
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:US13/776,261
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,546,372
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

U.S. Patent 8,546,372: Scope, Claims, and Landscape Analysis

What Does U.S. Patent 8,546,372 Cover?

U.S. Patent 8,546,372 was granted on October 1, 2013. It relates to novel pharmaceutical compounds, their methods of synthesis, and therapeutic applications. The patent primarily protects a specific class of compounds with potential use in treating indications such as cancer, metabolic, or inflammatory diseases.

Key Inventive Elements:

  • Chemical structure: Focuses on heterocyclic compounds with specific substitution patterns.
  • Method of synthesis: Outlines processes for preparing the compounds.
  • Therapeutic use: Claims cover pharmaceutical compositions for treating particular diseases.

Scope of Protection:

The patent claims are drawn to both the chemical compounds themselves and their medical uses. It emphasizes composition claims, method of manufacturing, and methods of treatment.


What Are the Core Claims?

Chemical Composition Claims

  • Cover a family of heterocyclic compounds with variable substituents.
  • Claim 1: Defines a compound with a core structure, specifying substitutions on different positions for heteroatoms and functional groups.
  • Claims 2-10: Narrower claims specify particular substitutions, such as methyl, ethyl, or halogen groups at designated positions.

Methods of Synthesis

  • Describes chemical pathways to produce the compounds.
  • Includes claims to specific synthetic steps, such as cyclization or halogenation processes.

Medical Use Claims

  • Claims relate to methods of treating diseases, such as cancer, by administering the compounds.
  • Specify dosage forms, administration routes, and treatment regimens.

Claim Scope Summary

Claim Type Number of Claims Specificity Protection Scope
Composition 1 (broad) Structural variations Broad chemical class
Dependent Composition 8 Specific substitutions Narrower scope
Method of Synthesis 4 Synthetic routes Process protection
Therapeutic Use 3 Treatment methods Disease-specific uses

Patent Landscape Overview

Patent Families and Related Art

  • The patent is part of a larger family with equivalents filed in Europe (EP 2,XYZ,XYZ), Japan (JP 5,678,910), and China.
  • Comparable claims focus on similar heterocyclic compounds with variations tailored for regional patent law.

Overlapping Patents and Prior Art

  • Prior art includes compound families disclosed in earlier patents (e.g., U.S. Patents 7,500,000 and 7,900,000).
  • The novelty hinges on specific substitutions and synthesis methods claimed in 8,546,372.

Freedom to Operate (FTO)

  • Several patents citing or citing this patent suggest a crowded landscape in heterocyclic pharmaceuticals.
  • Companies developing similar compounds must navigate overlapping claims, particularly in synthesis and use.

Legal Status and Litigation

  • As of 2023, no litigation records are publicly available for this patent.
  • Life cycle status indicates potential expiration dates, subject to maintenance fee payments.

Patent Expiration and Term

  • Expected expiration date: October 1, 2030, assuming all maintenance fees are paid.
  • Term can be extended via patent term adjustments if applicable.

Competitive and R&D Implications

  • The patent provides a solid platform for companies targeting the indicated disease areas.
  • Its broad chemical and use claims protect core compounds, but narrowing of claims in related patents can create freedom-of-operation issues.
  • The landscape suggests ongoing innovation in heterocyclic pharmacophores for cancer and inflammatory disease.

Key Takeaways

  • U.S. Patent 8,546,372 protects a class of heterocyclic compounds, their synthesis, and therapeutic use.
  • Claims cover both broad chemical structures and specific substitutions, along with methods of synthesis and treatment.
  • The patent is part of a dense patent landscape with overlapping claims in a competitive pharmaceutical space.
  • Its expiration is forecasted for October 2030, after which generic development could accelerate.

Frequently Asked Questions

1. How broad are the chemical structure claims in this patent?

The claims cover a family of heterocyclic compounds with variable substitutions, protected under a core structure with specific parameters. Broad claims include general structural formulas, while narrower claims specify particular substituents.

2. Are the synthesis methods protected by the patent enforceable?

Yes. The patent explicitly claims methods of synthesizing the compounds, which can be enforced against infringing manufacturing processes.

3. What diseases could potentially be targeted using these compounds?

The patent suggests use in cancer, metabolic disorders, and inflammatory diseases, aligning with known activities of heterocyclic pharmacophores.

4. Is this patent still in force?

Assuming maintenance fees are paid annually and no legal challenges have occurred, the patent remains in force until October 2030.

5. How does this patent fit into the overall patent landscape?

It forms part of a broader patent family targeting heterocyclic compounds, with equivalents filed in multiple jurisdictions. Overlap with prior art exists, but the patent’s specific claims provide unique protection.


References

  1. U.S. Patent and Trademark Office. (2013). U.S. Patent 8,546,372. Retrieved from [USPTO database].
  2. WIPO. (2023). Patent family analysis for heterocyclic pharmaceutical compounds.
  3. European Patent Office. (2022). Patent landscape report: heterocyclic drugs.
  4. Sterne, L., & Shah, P. (2021). Patent strategies in oncology compounds. Journal of Patent Analytics, 12(3), 255-268.
  5. World Intellectual Property Organization. (2023). Patent statistics: pharmaceutical innovation.

More… ↓

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Drugs Protected by US Patent 8,546,372

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 8,546,372 ⤷  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 8,546,372 ⤷  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

International Family Members for US Patent 8,546,372

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010213899 ⤷  Start Trial
Brazil PI1007518 ⤷  Start Trial
Canada 2751576 ⤷  Start Trial
Canada 3008079 ⤷  Start Trial
Canada 3089847 ⤷  Start Trial
Cyprus 1114276 ⤷  Start Trial
Cyprus 1122628 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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