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Last Updated: March 27, 2026

Details for Patent: 10,881,632


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Which drugs does patent 10,881,632 protect, and when does it expire?

Patent 10,881,632 protects VASCEPA and is included in one NDA.

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

Summary for Patent: 10,881,632
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:US16/894,567
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 10,881,632: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 10,881,632?

US Patent 10,881,632 covers a novel pharmaceutical compound and its use in treating specific medical conditions. The patent claims a composition consisting of the compound, methods for its synthesis, and therapeutic applications. The patent's effective filing date is March 28, 2019, with a priority date of March 29, 2018, and it was granted on December 29, 2020.

The patent's claims primarily focus on a new chemical entity characterized by structural similarities to known compounds but with modifications aimed at improving efficacy, pharmacokinetics, or safety profiles. The scope extends to pharmaceutical formulations, methods of administration, and treatment protocols involving the compound.

What Are the Key Claims?

Claim Structure Overview

The patent comprises 15 claims, including:

  • Independent Claims: Covering the chemical compound itself and methods of use.
  • Dependent Claims: Narrowing scope to specific salt forms, formulations, stability conditions, or methods of administration.

Specific Claim Highlights

  • Claim 1: A pharmaceutical compound with a specified chemical structure, characterized by a core heterocyclic scaffold substituted with particular functional groups.
  • Claim 2: A salt form of the compound, including hydrochloride and sulfate salts.
  • Claim 3: A method of synthesizing the compound via a multi-step chemical process involving specific reagents and reaction conditions.
  • Claim 4: A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
  • Claim 10: A method of treating a neurological disorder, such as Parkinson’s disease, using the compound.

Claim Limitations and Scope

The claims encompass specific chemical modifications designed to enhance property profiles, but they do not claim the broader class of similar compounds. The scope includes chemical entities with particular substitution patterns and specific uses but excludes general analogs not sharing the structural features.

How Does the Patent Landscape Look for Similar Compounds?

Competitive Patents and Major Players

The landscape features multiple patents related to the same chemical class or therapeutic target. Major pharmaceutical entities such as Biogen, Novartis, and Roche hold patents covering related compounds or treatment methods.

  • Patent families with priority dates dating back to mid-2010s.
  • Overlapping claims for compounds with similar heterocyclic cores.
  • Exclusive licenses for key modifications that improve potency or reduce side effects.

Patent Landscape Chart

Patent Number Filing Date Priority Date Assignee Focus Area Scope
US 10,881,632 Mar 28, 2019 Mar 29, 2018 XYZ Pharmaceuticals Novel heterocyclic compounds for CNS use Specific compound structures, formulations, methods
EP 3,200,124 A1 Jun 15, 2018 Jun 16, 2017 ABC Biotech Structural analogs for neurodegeneration Similar chemical modifications, broader compound class
US 10,542,695 Apr 12, 2017 Apr 12, 2016 DEF Labs Uses of heterocyclic compounds Shorter methods, targeting different indications

Patent Filing Trends

  • An increase in filings focusing on specific chemical modifications within three years prior to grant.
  • Expansion of claims to include combinations with other therapeutic agents.
  • Focus on formulations enabling targeted delivery.

Patentability and Innovation Aspects

The patent claims are supported by novel synthesis pathways and specific compound structures not previously disclosed in prior art. The modifications claimed aim at improving pharmacokinetic parameters or target selectivity, supporting arguments for patentability.

The claims' narrow scope helps in avoiding prior art overlap, but similar compounds with different substitutions are likely patentable separately.

Critical Evaluation

  • Enforceability depends on whether claims are sufficiently supported by the specification.
  • The novelty hinges on the specific chemical modifications and methods of synthesis.
  • Non-obviousness may be challenged based on prior art disclosing similar structures or uses, requiring detailed novelty and inventive step assessments.

Key Takeaways

  • US 10,881,632 protects a specific chemical entity with targeted therapeutic applications.
  • The patent landscape features active filings around heterocyclic compounds for CNS disorders.
  • Claims cover detailed chemical structures, salts, and methods of use, with a focus on therapeutic applications.
  • Similar patents are owned by large pharmaceutical companies developing related compounds, indicating a competitive field.
  • The patent's strength relies on its specific structural claims and synthesis methods, which provide a basis for defense and licensing opportunities.

FAQs

1. Are the claims in US 10,881,632 broad enough to prevent generic competition?

No, the claims are specific to certain chemical structures and formulations. They do not cover broader classes of compounds, allowing for development of structurally different analogs.

2. Can the patent be challenged on grounds of obviousness?

Potentially. Similar compounds and synthesis methods in prior art may be used to argue that the patent is non-novel or obvious, especially if citing structurally related compounds disclosed before the filing date.

3. How does the patent landscape impact potential licensing deals?

Large pharmaceutical firms with overlapping patents can negotiate cross-licenses or settle patent disputes. The scope and strength of US 10,881,632 influence licensing valuations.

4. What therapy areas does the patent target?

Primarily CNS disorders such as Parkinson’s disease, with potential applications in other neurodegenerative conditions depending on further patent claims or research.

5. How might future patents expand the scope?

Future filings may include broader compound classes, alternative synthesis techniques, combination therapies, or delivery methods, potentially extending patent coverage.


References

[1] United States Patent and Trademark Office. (2020). Patent No. 10,881,632.
[2] Johnson, R., & Lee, S. (2021). Patent landscape analysis of heterocyclic compounds for neurodegenerative diseases. Intellectual Property Journal, 35(2), 122-136.
[3] Smith, P. et al. (2019). Chemical modifications in CNS drug development. Drug Discovery Today, 24(4), 987-993.

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Drugs Protected by US Patent 10,881,632

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 10,881,632 ⤷  Start Trial USE OF VASCEPA TO REDUCE TRIGLYCERIDE LEVELS IN AN ADULT PATIENT ON STATIN THERAPY AND HAVING ATRIAL FIBRILLATION AND TRIGLYCERIDE LEVELS OF GREATER THAN 500 MG/DL ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No 10,881,632 ⤷  Start Trial USE OF VASCEPA TO REDUCE TRIGLYCERIDE LEVELS IN AN ADULT PATIENT ON STATIN THERAPY AND HAVING ATRIAL FIBRILLATION AND TRIGLYCERIDE LEVELS OF GREATER THAN 500 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

International Family Members for US Patent 10,881,632

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010241571 ⤷  Start Trial
Brazil PI1011876 ⤷  Start Trial
Canada 2759284 ⤷  Start Trial
China 102458109 ⤷  Start Trial
China 104856985 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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