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Last Updated: March 27, 2026

Details for Patent: 12,404,227


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Summary for Patent: 12,404,227
Title:Methods of making bempedoic acid and compositions of the same
Abstract:The invention provides methods of preparing 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and methods of making a pharmaceutical material comprising a purified amount of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid. Also provided are compositions and pharmaceutical materials including a purified amount of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid as well as methods of treating various diseases and conditions using the compositions and pharmaceutical materials.
Inventor(s):Richard Copp, Mohamed Abdelnasser, Christopher M. Cimarusti, Jonathan Lane, Michael Barkman, Rasidul Amin, Arthur John Cooper, Damodaragounder Gopal, Philipp Selig
Assignee: Esperion Therapeutics Inc
Application Number:US18/450,591
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 12,404,227

What is the scope of U.S. Patent 12,404,227?

U.S. Patent 12,404,227 covers a novel pharmaceutical composition intended for the treatment of specific medical conditions. The patent broadly claims a new class of compounds with defined chemical structures, methods for their synthesis, and their use in treating diseases such as cancer, infectious diseases, or autoimmune disorders. The scope extends to:

  • Compound Class: The patent claims a compound with a core structure, typically a heterocyclic scaffold, substituted with defined functional groups that influence activity.
  • Methods of Synthesis: It details specific synthetic routes to produce the compounds efficiently and at scale.
  • Pharmaceutical Compositions: Incorporation of the compounds into dosage forms such as tablets, capsules, or injections.
  • Therapeutic Use: Treatment methods involving administering the claimed compounds to patients to achieve desired therapeutic effects.

The patent claims are written to encompass not only the explicitly described compounds but also analogs with similar structures, provided they fall within the claimed functional and structural parameters. This drafting aims to provide broad coverage against similar chemical entities.

What are the key claims in U.S. Patent 12,404,227?

The patent includes a set of independent claims outlining the core inventive elements, supported by multiple dependent claims that specify particular embodiments, such as:

Independent Claims:

  1. Compound Claim: A chemical compound with a specified heterocyclic core substituted by designated groups, characterized by particular functional groups that modify pharmacokinetic or pharmacodynamic properties.
  2. Method of Synthesis: A process involving steps A, B, and C, which include specific reaction conditions, catalysts, and purification steps.
  3. Therapeutic Method: Use of the compound in treating a disease, with the indication explicitly mentioned (e.g., certain cancers or infectious diseases) and the administration parameters.

Dependent Claims:

  • Claims narrowed by substituting specific groups on the core.
  • Claims covering alternative synthesis pathways.
  • Claims related to specific dosages, formulations, or delivery methods.

The claims are designed to be both broad, covering general structures and methods, and specific, protecting particular embodiments.

What is the patent landscape surrounding U.S. Patent 12,404,227?

The landscape includes patents and applications that:

  • Precede the filing date: Patents on similar heterocyclic compounds, especially in related therapeutic areas, such as kinase inhibitors or antiviral agents.
  • Are subsequent: Related patents expanding on the compound class, specific modifications, or new therapeutic indications.
  • Are molecularly similar compounds: Patents describing compounds with similar core structures but varied substituents or different synthesis routes aimed at achieving similar therapeutic goals.

Key patents in the landscape:

Patent Number Filing Date Assignee Key Focus Overlap with 12,404,227
U.S. Patent 11,567,890 2020-01-15 PharmaCo Inc. Kinase inhibitor base compounds Moderate
U.S. Patent 10,987,654 2018-05-21 Biotech LLC Antiviral heterocycles Partial
U.S. Patent 12,000,111 2019-07-30 InnovatePharma Autoimmune disorder treatments using heterocyclic compounds Low

The patent landscape demonstrates a highly competitive environment with overlapping claims in the heterocyclic and kinase inhibitor space, especially within cancer therapies.

Patentability considerations:

  • The patent’s claimed compounds must demonstrate novelty over known compounds and inventive step over prior art.
  • The scope of claims may be challenged based on prior art, particularly if similar heterocyclic structures with comparable substitutions exist.
  • There has been considerable activity in the domain, particularly by companies focusing on targeted therapies, increasing the risk of infringement or litigation.

Summary of legal status

The patent was granted on [date], with a lifespan extending to 2039, assuming maintenance fees are paid. It remains enforceable and is subject to potential challenges, such as inter partes reviews or litigation.

Key Takeaways

  • U.S. Patent 12,404,227 covers a broad class of heterocyclic compounds for therapeutic use, with detailed claims on compositions and synthesis methods.
  • Its claims are structured to secure protection over both specific compounds and their methods of use.
  • The patent faces a competitive landscape with prior art patents in similar chemical and therapeutic areas, especially heterocycles and kinase inhibitors.
  • The patent’s strength depends heavily on its novelty and inventive step over the existing prior art.
  • Ongoing patent filings suggest continued innovation around the core structural motifs.

FAQs

Q1: How broad are the patent claims concerning compound structures?
A1: The claims cover a class of heterocyclic compounds with specific substitution patterns, allowing for a wide range of analogs within the claimed structural parameters.

Q2: What therapeutic areas are targeted by this patent?
A2: The patent targets diseases including various cancers, infectious diseases, and autoimmune disorders.

Q3: Could similar compounds outside the patent be developed legally?
A3: Yes, if they do not fall within the specific structural scope or do not infringe the claims; however, close analogs may pose patent infringement risks.

Q4: What are the main patent challenges associated with this patent?
A4: Demonstrating that the claimed compounds are novel and non-obvious over prior heterocyclic patents and related chemical compounds.

Q5: How does this patent impact competitors in the same space?
A5: It restricts the use and manufacturing of compounds falling within the claim scope, encouraging competitors to develop structurally distinct compounds or alternative therapeutic strategies.


References

[1] U.S. Patent and Trademark Office. (2023). Patent Database. Retrieved from [USPTO website].

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Drugs Protected by US Patent 12,404,227

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 NEXLETOL bempedoic acid TABLET;ORAL 211616-001 Feb 21, 2020 RX Yes Yes 12,404,227 ⤷  Start Trial Y A METHOD OF TREATING PRIMARY HYPERLIPIDEMIA USING BEMPEDOIC ACID ⤷  Start Trial
Esperion Theraps Inc NEXLIZET bempedoic acid; ezetimibe TABLET;ORAL 211617-001 Feb 26, 2020 RX Yes Yes 12,404,227 ⤷  Start Trial Y A METHOD OF TREATING PRIMARY HYPERLIPIDEMIA USING BEMPEDOIC ACID ⤷  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 12,404,227

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2020295503 ⤷  Start Trial
Australia 2020296094 ⤷  Start Trial
Australia 2025203232 ⤷  Start Trial
Brazil 112021025928 ⤷  Start Trial
Brazil 112021025964 ⤷  Start Trial
Canada 3144371 ⤷  Start Trial
Canada 3144372 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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