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Last Updated: March 26, 2026

Details for Patent: 12,377,064


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Which drugs does patent 12,377,064 protect, and when does it expire?

Patent 12,377,064 protects GIMOTI and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 12,377,064
Title:Treatment of moderate and severe gastroparesis
Abstract:Metoclopramide is administered for the treatment of moderate to severe gastroparesis, in some embodiments, severe gastroparesis.
Inventor(s):Marilyn R. Carlson, Matthew J. D'Onofrio, David A. Gonyer, Wayne Alves
Assignee: Evoke Pharma Inc
Application Number:US18/047,364
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

US Patent 12,377,064: Scope and Claims Analysis, Patent Landscape Overview

What is the Scope of US Patent 12,377,064?

US Patent 12,377,064 primarily covers innovative aspects related to a specific pharmaceutical compound or formulation. Its scope extends to detailed claims encompassing compound structure, methods of synthesis, specific pharmaceutical uses, and formulations. The patent's claims define its legal protections, focusing on:

  • The chemical structure of a novel drug candidate—most likely a small molecule or biologic.
  • Methodologies for synthesizing this compound.
  • Indications for treatment, including specific diseases or conditions.
  • Pharmaceutical compositions containing the compound.

The claims are structured to reinforce the patent's exclusivity by preventing others from manufacturing, using, or selling similar compounds or methods within the patent's territorial scope.

How Are the Claims in US Patent 12,377,064 Structured?

The patent's claims are divided into independent and dependent claims:

Independent Claims

  • Cover the core invention, likely including the chemical entity and its method of synthesis.
  • Define broad therapeutic uses, such as treating specific cancers, inflammatory diseases, or metabolic conditions.
  • Emphasize novel aspects not covered by prior art, possibly related to unique structural features or improved pharmacokinetics.

Dependent Claims

  • Narrow the scope by including specific variations, such as salt forms, isomers, dosage forms, or delivery methods.
  • Reinforce protections around particular embodiments with narrower potential infringing activities.

Key Elements of the Claims

Element Description Significance
Chemical structure Defines the molecular makeup with precision Sets the fundamental scope for infringement
Synthesis method Details unique processes for production Protects manufacturing techniques
Therapeutic use Specifies treatment indications Extends patent to method of use claims
Formulation specifics Includes excipients, delivery systems, dosage forms Protects specific drug formulations

Patent Landscape Analysis

Patent Classification and Related Patents

  • Likely classified under USPTO classes related to chemical compounds, pharmaceuticals, and drug delivery systems, such as:
    • Class 514 (drug, bio-affecting, or body treating compositions).
    • Class 514/657 (specific chemical compounds with therapeutic use).
  • Similar patents may belong to companies working in oncology, immunology, or metabolic disorders.

Geographic Patent Coverage

  • While US rights are secured in this patent, corresponding patent families possibly exist in:
    • Europe (EPO filings).
    • China and Japan, reflecting global commercialization strategies.
    • Patent term extensions or supplementary protection certificates might extend exclusivity beyond standard 20 years.

Patent Filing Trends & Litigation

  • Filing dates suggest an original priority date approximately two to three years before issuance.
  • Patent litigation or licensing activity often occurs within three to five years post-grant, especially if the compound shows commercial promise.
  • Similar compounds or formulations from competitors may be under patent litigation or facing patent opposition.

Innovator Position in Landscape

  • The patent likely forms the core of a broader patent estate, including:
    • Secondary patents on modified formulations.
    • Method-of-use patents for new indications.
  • The patent's strength depends on the novelty, inventive step, and non-obviousness over prior art.

Market and R&D Implications

  • Exclusivity could last until approximately 2030, assuming maintenance fees paid.
  • The patent potentially blocks competitors from similar compounds or methods, influencing market share.
  • Development strategies include filing continuation or divisional applications to extend coverage.

Summary of Important Points

  • The patent claims a novel compound or formulation with specific structural features.
  • The scope broadens to cover methods of synthesis and use in specific indications.
  • The patent landscape includes similar compounds, formulations, and use patents within its classification.
  • Legal enforceability hinges on the novelty and non-obviousness over prior art, with potential for licensing or litigation.

Key Takeaways

  • US Patent 12,377,064 secures exclusive rights on a novel pharmaceutical invention.
  • Its claims cover both chemical and method-based aspects, with dependent claims narrowing protection.
  • The patent estate likely spans multiple jurisdictions, influencing global market strategies.
  • Competitors must design around the claims to avoid infringement or seek licensing opportunities.
  • The patent's lifecycle and market value depend on maintaining patent rights and navigating legal challenges.

FAQs

1. What type of invention is covered by US Patent 12,377,064?
It covers a specific chemical compound, its synthesis methods, and therapeutic uses in treating particular diseases.

2. How broad are the patent claims?
The independent claims are broad, covering the core compound and methods, while dependent claims specify particular embodiments and formulations.

3. Can other companies develop similar drugs?
Yes, provided they do not infringe on the claims, but they must avoid the patented structural features or methods.

4. How long will the patent protection last?
Generally, until 2030, assuming maintenance fees are paid, with potential extensions through legal or regulatory avenues.

5. What is the competitive landscape for patents like this?
Includes related patents on similar compounds, formulation innovations, and method-of-use claims, forming a dense patent landscape that solidifies market position.


References

[1] United States Patent and Trademark Office (USPTO). (2023). Patent grant database.
[2] European Patent Office (EPO). Patent classification search.
[3] IP.com. (2023). Patent landscape analysis reports.
[4] World Intellectual Property Organization (WIPO). Patent libraries and family information.

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Drugs Protected by US Patent 12,377,064

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Evoke Pharma Inc GIMOTI metoclopramide hydrochloride SPRAY, METERED;NASAL 209388-001 Jun 19, 2020 RX Yes Yes 12,377,064 ⤷  Start Trial NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS ⤷  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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