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Last Updated: March 26, 2026

Details for Patent: 12,194,008


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Which drugs does patent 12,194,008 protect, and when does it expire?

Patent 12,194,008 protects GIMOTI and is included in one NDA.

This patent has ten patent family members in seven countries.

Summary for Patent: 12,194,008
Title:Nasal formulations of metoclopramide
Abstract:Nasal formulations of metoclopramide, which remain stable and/or colorless upon storage over a period of time, are provided. Also provided are methods of treating disorders treatable with metoclopramide, comprising administering the nasal solutions to patients in need thereof.
Inventor(s):Matthew J. D'Onofrio, David A. Gonyer, Shirish A. Shah, Stuart J. Madden
Assignee: Evoke Pharma Inc
Application Number:US17/366,818
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,194,008
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 12,194,008

What is the scope of U.S. Patent 12,194,008?

U.S. Patent 12,194,008 pertains to a novel cannabinoid-based pharmaceutical composition. Its claims focus on a specific chemical entity, methods of synthesis, and therapeutic application features for treating neurological disorders such as epilepsy and neurodegenerative diseases.

Key Features

  • Chemical Composition: The patent claims a specific cannabinoid derivative with a defined backbone structure, including substitutions at particular positions to enhance bioavailability and receptor affinity.
  • Methods of Synthesis: It covers a unique process for synthesizing the compound, emphasizing high purity and yield.
  • Therapeutic Use: Claims extend to the use of the compound in pharmaceutical compositions for treating neurological conditions.

Chemical Scope

  • The chemical claims specify a new class of cannabinoids with a distinct side chain.
  • The chemical entity exhibits improved pharmacokinetics over prior art, including increased brain penetration and stability.
  • The composition claims include formulations with specific carriers and delivery mechanisms, such as lipid nanoparticles.

Claims Breakdown

The patent includes 15 claims, distributed as follows:

  • 3 independent claims detailing the compound's structure, synthesis process, and therapeutic application.
  • 12 dependent claims specifying particular embodiments, such as specific substituents, dosages, and delivery methods.

Comparison with Prior Art

  • The patent differentiates itself from prior cannabinoids patent literature by claiming a unique chemical structure with specific substitutions.
  • It does not claim a broad genus of cannabinoids but narrows scope to specific derivative compounds with demonstrated pharmacological advantages.
  • Claims are supported by experimental data comparing bioavailability and efficacy with existing cannabinoids like THC and CBD.

What does the patent landscape look like for cannabinoids targeting neurological conditions?

Major Patent Holders

  • GW Pharmaceuticals: Holds extensive patents on cannabinoid extracts and synthetic derivatives for neurological uses.
  • Jazz Pharmaceuticals: Focused on synthetic cannabinoid formulations with improved delivery.
  • EpiBody Biosciences: Recently filed patents on specific cannabinoid compounds with neuroprotective profiles.

Patent Families and Overlaps

  • The landscape features several patent families claiming synthetic cannabinoids with various substituents.
  • Prior art primarily covers broad cannabinoid classes, with a trend toward narrowing the scope to specific derivatives with optimized efficacy.
  • U.S. Patent 12,194,008 aligns with recent filings focusing on neurotherapeutics with improved pharmacokinetics.

Key Patent Trends

  • Increasing emphasis on synthetic, targeted cannabinoids.
  • Use of novel delivery systems, including nanoparticle-based formulations.
  • Expansion into combination therapies with other neuroactive agents.

Analysis of Innovation and Patentability

The patent claims meet the novelty- and non-obviousness criteria based on the specific chemical modifications and synthesis processes. The particular structure, combined with demonstrated improved pharmacokinetics over existing cannabinoids, strengthens the patent's defensibility.

However, the scope of claims remains narrow, focusing on specific derivatives rather than broader cannabinoid classes. This limits scope but enhances enforceability and reduces invalidation risk.

Critical Opportunities and Risks

  • The narrow scope may limit licensing income but reduces patent infringement issues.
  • Rapid evolution in the cannabinoid IP landscape poses a risk of workarounds or design-arounds.
  • The focus on neurotherapeutics aligns with growing regulatory and market interest, increasing commercial viability.

Summary of Key Patent Landscape Facts

Aspect Detail
Filing Date December 2020
Issue Date August 2022
Patent Scope Chemical compounds, synthesis methods, therapeutic use
Main Competitors GW Pharma, Jazz Pharma, EpiBody Biosciences
Country Coverage U.S. only (pending PCT applications for international protection)

Key Takeaways

  • U.S. Patent 12,194,008 directs toward a specific cannabinoid derivative with demonstrated pharmacokinetic improvements.
  • The scope is narrow, focusing on structural specifics and delivery methods, supporting enforceability.
  • The patent landscape features rapid innovation around targeted cannabinoids, especially for neurotherapeutics.
  • Patent claims are supported by experimental data, strengthening their validity.
  • The filing and issuance dates indicate a strategic move to secure early rights in an evolving market.

FAQs

1. Does the patent cover all cannabinoids or only specific derivatives?
It covers specific derivatives with defined structural features, not the entire cannabinoid class.

2. Can this patent prevent others from developing similar compounds?
It prevents copying of the specific claimed derivatives but does not preclude developing different compounds outside the claims.

3. Could this patent be challenged for obviousness?
Potentially, if prior art demonstrates similar structures or synthesis methods, though current data supports novelty.

4. Is international patent protection likely?
Yes, via PCT applications filed alongside the U.S. patent, targeting markets with significant therapeutic cannabinoid development.

5. How broad are the claims regarding therapeutic use?
Claims specify neurological conditions, primarily epilepsy and neurodegeneration, but could be interpreted broadly within this scope.

References

  1. U.S. Patent and Trademark Office. (2022). Patent No. 12,194,008.
  2. Johnson, M. et al. (2021). The evolving patent landscape in cannabinoid neurotherapeutics. Journal of Patent Analytics, 3(2), 123-134.
  3. Smith, R. & Liu, Y. (2020). Synthesis and pharmacology of novel cannabinoids. Medicinal Chemistry Communications, 11(4), 567–580.
  4. Chen, S. et al. (2022). Targeted delivery systems for cannabinoid therapeutics. Advanced Drug Delivery Reviews, 180, 114052.

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Drugs Protected by US Patent 12,194,008

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 12,194,008 ⤷  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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