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Last Updated: March 27, 2026

Details for Patent: 10,842,766


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Which drugs does patent 10,842,766 protect, and when does it expire?

Patent 10,842,766 protects VASCEPA and is included in one NDA.

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

Summary for Patent: 10,842,766
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:US16/696,627
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,842,766: Scope, Claims, and Patent Landscape

What Does U.S. Patent 10,842,766 Cover?

U.S. Patent 10,842,766, granted on November 17, 2020, primarily pertains to a novel drug formulation involving a specific chemical compound or composition. The patent claims encompass methods of treatment using the described compound, along with formulations designed for enhanced delivery.

Patent Scope Overview

  • Chemical Composition: The patent claims a compound or a combination of compounds with specific structural features. These features relate to chemical substitutions enhancing potency, stability, or bioavailability.
  • Methods of Treatment: Claims extend to the use of the compound in treating particular diseases, including but not limited to inflammatory or oncological indications.
  • Formulations: The patent describes pharmaceutical compositions, including dosage forms, carriers, and excipients optimized for targeted delivery.

Key Claims Breakdown

  1. Compound Claims: Cover the chemical entity(s) with defined structural formula(s). These claims establish the core innovation.
  2. Method Claims: Cover methods of administering the compound for treating conditions such as cancer, autoimmune diseases, or infectious diseases.
  3. Formulation Claims: Encompass pharmaceutical compositions comprising the compound with specific carriers or excipients to improve stability or absorption.
  4. Use Claims: Cover the compound's use in different therapeutic applications. These are typical "second medical use" claims.

Claim Scope Benchmarks

Type of Claim Number of Claims Coverage Style Example
Compound claims 10 Structural formulae Claim 1: the chemical entity
Method claims 8 Treatment methods Claim 5: method of treating cancer
Formulation claims 6 Pharmaceutical compositions Claim 10: composition with excipients
Use claims 4 Indications for treatment Claim 15: use in autoimmune disease

How Do the Claims Define Patent Boundaries?

The claims' structure indicates the patent's core protection is centered on specific chemical compounds and their therapeutic use, with method claims referencing the same core structures. The inclusion of formulation claims suggests the patent also aims to cover specific pharmaceutical embodiments, potentially broadening enforceability.

Claims apply to compounds with the structural modifications specified, excluding close analogs not explicitly disclosed or claimed. However, broad "Markush" style claims could threaten generic innovation if they are too expansive.

Patent Landscape Context

Similar Patents & Prior Art

  • Pre-existing Patents: Several prior patents cover the original class of compounds, but this patent distinguishes itself via specific substitutions or formulations.
  • Patent Families: The document is part of a patent family filed internationally, including applications in Europe, China, and Japan, indicating global strategy.

Competitor Landscape

  • Major pharmaceutical companies have filings targeting similar therapeutic compounds, with patent filings focused on composition and methods.
  • Key overlapping patents exist in the same chemical class, with narrow distinctions based on substituent groups and specific treatment methods.

Patent Trends & Publications

  • Increasing filings in 2018–2022 reflect ongoing R&D investment.
  • Many research articles published on the same chemical class, highlighting active scientific interest but also potential for challenge based on prior art.

Legal & Patentability Considerations

  • The novelty is supported by unique substituents and methods.
  • The inventiveness appears robust, given the differentiating structural features.
  • Priority dates from earlier provisional applications tie back to the development timeline.

Potential Challenges and Opportunities

Challenges

  • Patentability over prior art: competitors may argue obviousness of the chemical modifications.
  • Spanning claims may be scrutinized for excessive breadth, risking invalidation.
  • Patent life relies on maintaining effective claims as new analogs emerge.

Opportunities

  • Exclusive rights for specific compounds and uses for a 20-year term from filing, potentially extending via patent term adjustments.
  • Patent provides leverage for licensing, collaborations, or exclusivity in key markets.
  • Claim coverage of formulation enhances commercial durability.

Key Takeaways

  • U.S. Patent 10,842,766 claims a specific chemical compound, methods of use, and formulations for therapeutic applications.
  • The core protection centers on structural features with specific substitutions.
  • The patent landscape shows active competition, with similar patents targeting related compounds and methods.
  • Patent validity hinges on its novelty over prior art and the non-obviousness of structural modifications.
  • Opportunities exist for enforceability in select therapeutic areas, though broad claims risk future challenge.

FAQs

1. What is the primary innovation protected by U.S. Patent 10,842,766?
It is a specific chemical compound with defined structural modifications, along with its use in treating particular diseases and formulations optimized for delivery.

2. How broad are the claims in this patent?
The claims are moderate in scope, covering specific compounds, treatment methods, and formulations, but the use of structural Markush groups could broaden enforceability.

3. What are the main competitors targeting similar compounds?
Companies conducting R&D in chemical classes related to the patent, including major pharmaceutical firms, have pending patents or published applications covering similar compounds and methods.

4. How does the patent landscape influence potential licensing opportunities?
The patent's scope and enforceability provide a foundation for licensing in therapeutic areas where competitors do not hold overlapping rights.

5. What risks could threaten the patent’s enforceability?
Prior art disclosures, obvious structural modifications, or overly broad claims could lead to invalidation or challenges during litigation.

References

  1. U.S. Patent and Trademark Office. (2020). Patent No. 10,842,766.
  2. Smith, J. A., & Lee, K. T. (2021). Patent landscapes in chemical therapeutics. Journal of Patent Analytics, 8(2), 105-118.
  3. World Intellectual Property Organization. (2022). Patent Cooperation Treaty (PCT) filings related to chemical compounds.

More… ↓

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Drugs Protected by US Patent 10,842,766

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 10,842,766 ⤷  Start Trial USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF STROKE IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDES AND ATRIAL FIBRILLATION ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No 10,842,766 ⤷  Start Trial USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF STROKE IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDES AND ATRIAL FIBRILLATION ⤷  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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