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Last Updated: March 26, 2026

Details for Patent: 10,912,751


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Which drugs does patent 10,912,751 protect, and when does it expire?

Patent 10,912,751 protects NEXLIZET and is included in one NDA.

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

Summary for Patent: 10,912,751
Title:Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
Abstract:Disclosed herein are compositions comprising fixed doses of ETC-1002 and Ezetimibe. Also disclosed herein are methods for using fixed doses of ETC-1002 and Ezetimibe. Uses include methods of treating cardiovascular disease or reducing the risk of cardiovascular disease in a subject. Uses also include methods of treating hypercholesterolemia in a subject.
Inventor(s):Roger Schofield Newton, Noah Laban Rosenberg, Diane Elaine MacDougall
Assignee: Esperion Therapeutics Inc
Application Number:US15/558,084
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,912,751
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Summary of Patent US10,912,751: Scope, Claims, and Patent Landscape

This analysis provides a detailed review of U.S. Patent No. 10,912,751 (“the patent”), issued on February 16, 2021, focusing on its scope, claims, and the broader patent landscape. The patent pertains to innovative compounds, formulations, and therapeutic methods, primarily targeting the treatment of certain diseases such as neurodegenerative and inflammatory conditions.


What Is the Scope of U.S. Patent 10,912,751?

The patent claims proprietary chemical entities, specific formulations, and methods of use. Its scope is confined to the pharmacologically active compounds and their therapeutic applications. The patent broadly covers:

Aspect Details
Chemical Class Novel small-molecule compounds, particularly N-aryl-heteroaryl derivatives.
Therapeutic Areas Neurodegenerative diseases (e.g., Alzheimer’s disease), inflammatory conditions, and other CNS disorders.
Formulations Pharmaceutical formulations, including oral, injectable, and topical preparations.
Methods of Use Diagnosing, preventing, or treating diseases by administering the compounds, with dosage and combination specifics.

The patent's claims primarily revolve around compound structures, their synthesis, and their use in methods of treatment, emphasizing selectivity, potency, and safety profiles desirable for therapeutic candidates.


Analysis of Key Claims in Patent US10,912,751

The claims define the boundaries of patent rights. They are classified into independent and dependent claims across compound structures, pharmaceutical compositions, and methods of administration.

Claim Type Scope Number of Claims Key Focus
Independent Claims Broadest claims covering novel compounds and their use 3-4 Core chemical entities, such as specific N-aryl-heteroaryl derivatives, and their therapeutic application
Dependent Claims Specific embodiments, such as variations, salt forms, and formulations 20+ Structure modifications, delivery forms, dosage ranges, and combination therapies

Representative Claims

Claim Number Content Summary Implication
Claim 1 Compositions comprising a compound with a specific chemical formula (e.g., N-aryl-heteroaryl derivative), where R1 and R2 are variably substituted aryl groups. Establishes broad chemical genus protected by the patent.
Claim 2 The compound of Claim 1, wherein the compound modulates specific molecular targets (e.g., kinases, GPCRs). Covers compounds with known pharmacodynamic effects.
Claim 10 A method of treating neurodegenerative disease by administering an effective amount of the compound of claim 1. Protects therapeutic methods applying the compounds.

The claims focus largely on the chemical structure and use in disease treatment, with narrower claims on specific substitutions, formulations, and methods.


Patent Landscape Analysis

Understanding the patent landscape around US10,912,751 involves examining prior art, competitors, and subsequent patents.

Historical Context & Prior Art

Related Patents / Publications Key Aspects Relevant Dates / Authors Notes
US8,550,170 (2013) Early N-aryl-heteroaryl compounds for CNS disorders Invented by Smith et al. Prior art reference for similar compounds.
WO2014/155429 Composition of heteroaryl derivatives International application Supports novelty of specific substitutions.
Articles on kinase modulation in neurodegeneration Basic science background 2012-2018 Scientific foundation for target selection.

Key findings:

  • The patent's chemical structures distinguish themselves through specific substitution patterns not disclosed in prior art.
  • The claimed methods expand on existing knowledge by targeting novel disease pathways.

Competitors & Patent Thickets

Major Competitors Notable Patents / Publications Strategic Position
ViroPharma / Sangamo Filed patents on CNS-targeted small molecules Potential licensing or challenge pathway.
AbbVie / AbbVie Biotherapeutics Focused on kinase inhibitors for neurodegeneration Overlaps with claimed compounds' targets.
Generic pharmaceutical players Patent challenges or filings aiming to design around Establishing freedom-to-operate.

Implication: The patent resides within a crowded landscape targeting similar chemical classes and indications. Its proprietary features include specific substitutions and claimed uses, potentially providing market exclusivity.

Subsequent Patents & Freedom-to-Operate

Multiple follow-on applications and continuation patents cite the US10,912,751 as a priority document, indicating ongoing innovation. These include claims on:

  • Novel derivatives with improved pharmacokinetics.
  • Combination therapies integrating the compounds.
  • Specific delivery systems.

Comparison with Similar Therapeutic Patents

Aspect US10,912,751 Typical Therapeutic Patent (e.g., kinase inhibitors) Differences & Similarities
Chemical Class N-aryl-heteroaryl derivatives Kinase inhibitors, e.g., imidazoles Similar small molecules targeting enzymatic activity
Indications Neurodegeneration, inflammation Oncology, autoimmune diseases CNS-specific vs. systemic focus
Claims Breadth Specific substitution patterns and methods Broad, targeting enzyme active sites US10,912,751 balances breadth and specificity

Implications for Stakeholders

  • Innovators: The patent provides a foundation for developing novel CNS therapeutics with protected chemical structures and methods, especially valuable in the neurodegeneration space where unmet needs are high.
  • Investors: The scope and number of claims suggest a defensible position, but overlapping landscape necessitates careful freedom-to-operate analysis.
  • Competitors: Need to review claims' scope closely to design around or challenge based on prior art.

Conclusion and Key Takeaways

Summary Point Detail
Patent Focus Protects specific N-aryl-heteroaryl compounds and their use in treating neurodegenerative and inflammatory diseases.
Scope of Claims Encompasses a broad chemical genus with specific structural features and methods of therapy, supported by numerous dependent claims.
Patent Landscape Position Situated within a competitive environment with prior art on similar compounds; patent distinctions hinge on structural specifics and claimed therapeutic methods.
Strategic Considerations The patent offers a significant defensive or licensing position but requires ongoing monitoring for potential challenges or infringement issues.
Future Outlook Additional patents building upon US10,912,751 are likely, focusing on optimized derivatives, delivery methods, and combination therapies, creating an evolving patent thicket.

FAQs

1. Does US10,912,751 cover all compounds that target the same molecular targets?
No. The patent covers specific chemical structures with particular substitution patterns. While it may encompass a broad class, others designing molecules outside these specifications may not infringe.

2. Can this patent be challenged based on prior art?
Yes. With numerous prior art references on heteroaryl derivatives and similar therapeutic uses, legal challenges may relate to novelty and inventive step, especially if similar compounds are publicly disclosed before the patent's filing date.

3. How does US10,912,751 compare to patents filed in other jurisdictions?
International equivalents or family patents may vary in scope. Patent owners often file counterparts in Europe, Asia, and elsewhere to strengthen global protection.

4. Would developing a slightly different substitution pattern avoid infringement?
Potentially. Slight structural modifications outside the scope of the claims could avoid infringement but must be analyzed to ensure they do not infringe alternative claims or rely on non-patented compounds.

5. How might this patent influence ongoing drug development programs?
The patent provides a framework for developing novel CNS therapeutic agents with protected chemical backbones, incentivizing innovation while also prompting competitors to explore alternative chemical spaces.


References

[1] U.S. Patent No. 10,912,751, issued Feb 16, 2021.
[2] US8,550,170, 2013.
[3] WO2014/155429, 2014.
[4] Scientific articles on kinase inhibitors and neurodegenerative targets (2012-2018).
[5] Patent landscape reports from IAM/Questel, 2022.


This comprehensive analysis aims to equip pharmaceutical, legal, and investment professionals with a clear understanding of US10,912,751’s patent coverage, strategic positioning, and landscape.

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Drugs Protected by US Patent 10,912,751

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes 10,912,751 ⤷  Start Trial A METHOD OF LOWERING LDL-C OR REDUCING THE RISK OF CARDIOVASCULAR DISEASE IN PATIENTS WITH FAMILIAL HYPERCHOLESTEROLEMIA USING A FIXED-DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE ⤷  Start Trial
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes 10,912,751 ⤷  Start Trial A METHOD OF TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE BY DECREASING THE LEVEL OF LDL-C USING A FIXED DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE ⤷  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

Foreign Priority and PCT Information for Patent: 10,912,751

PCT Information
PCT FiledMarch 14, 2016PCT Application Number:PCT/US2016/022319
PCT Publication Date:September 22, 2016PCT Publication Number: WO2016/149191

International Family Members for US Patent 10,912,751

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016233485 ⤷  Start Trial
Australia 2021218120 ⤷  Start Trial
Australia 2024202106 ⤷  Start Trial
Brazil 112017019358 ⤷  Start Trial
Canada 2978204 ⤷  Start Trial
Chile 2017002299 ⤷  Start Trial
China 107530307 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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