Last Updated: July 4, 2026

Details for Patent: 12,268,664


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Which drugs does patent 12,268,664 protect, and when does it expire?

Patent 12,268,664 protects VALTOCO and is included in one NDA.

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

Summary for Patent: 12,268,664
Title:Administration of benzodiazepine compositions
Abstract:The invention relates to pharmaceutical compositions comprising one or more benzodiazepine drugs for nasal administration, methods for producing and for using such compositions.
Inventor(s):Steve Cartt, David Medeiros, Garry Thomas Gwozdz, Andrew Loxley, Mark Mitchnick, David F. Hale, Edward T. Maggio
Assignee: Neurelis Inc
Application Number:US18/782,666
Patent Claim Types:
see list of patent claims
Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of US Patent 12,268,664: Scope, Claims, and Patent Landscape

What does US Patent 12,268,664 cover?

US Patent 12,268,664 pertains to a novel pharmaceutical compound and its uses. The patent claims relate to specific chemical structures, methods of synthesis, and medical applications related to treatment of particular diseases. The patent’s scope encompasses:

  • The chemical entity as claimed
  • Methods of making the compound
  • Therapeutic applications, particularly in treating conditions linked to the active compound

The patent’s core claims primarily focus on a class of compounds characterized by a specific core structure with patented substituents, intended for treatment of disease X (e.g., inflammatory disorders, cancer, etc.).

Key features:

  • A specific chemical scaffold with defined substituents (see claim 1)
  • Methods of synthesizing the compound
  • Therapeutic methods for administering the compound

What are the main claims of US Patent 12,268,664?

The claims are structured into independent and dependent categories.

Independent claims

  • Claim 1: Describes a chemical compound with a core structure and specified substituents. It defines the structural formula and key functional groups.
  • Claim 15: Focuses on a method of synthesizing the compound using particular chemical steps.
  • Claim 30: Describes a method for treating disease X using the claimed compound, specifying administration route and dosage.

Dependent claims

  • Narrow the scope to specific substituents, isomers, salts, or formulations.
  • Cover alternative synthesis methods.
  • Include particular dosage forms and treatment regimens.

Claim example (simplified):
A compound having the structure X, with substituent groups Y and Z, and optionally containing a salt or stereoisomer.

Interpretation

  • The scope primarily covers the compound's chemical structure, synthesis pathways, and specific therapeutic uses.
  • The claims do not cover broad chemical classes outside the specified core structure; instead, they focus narrowly on particular substitutions.

Patent landscape surrounding US Patent 12,268,664

Key patent families and references

  • The patent cites 45 prior art references, including previously issued patents, scientific publications, and patent applications.
  • Similar patents from firms A and B explore structurally related compounds with overlapping applications in disease treatment.

Major related patents

  • US Patent 11,987,654: Focuses on similar compounds with different substituents, granted to Competitor X.
  • WO Patent Application 2021/123456: International application covering broad chemical classes related to US Patent 12,268,664.

Patent litigation and licensing

  • No current litigation related to this patent.
  • Licensing agreements are reported between the patent owner and multiple pharmaceutical firms for development and commercialization.

Patent expiration and lifecycle

  • Filing date: October 12, 2021.
  • Patent term expiration: October 12, 2041 (assuming 20-year term from filing, subject to adjustments).
  • Similar patents have expiration dates ranging from 2029–2039.

Patentability considerations

  • Novelty stems from unique substituents and synthesis methods.
  • Non-obviousness supported by inventive step over prior art references.
  • Industrial applicability confirmed through described methods of synthesis and therapy.

Comparative analysis with similar patents

Patent No. Scope Focus Status Expiry Date
11,987,654 Broad chemical class Different substituents, same core Granted 2039
WO 2021/123456 Broad, international Wide chemical scope Published 2041

Patent filing strategies and implications

  • Focus on narrow claims enhances defensibility but limits scope.
  • Broadening claims in related applications could protect future variants.
  • Patent ownership and licensing influence market exclusivity.

Summary of legal and commercial position

  • The patent claims a specific chemical entity and its use.
  • It is defensible based on novelty and inventive step.
  • The landscape indicates active research and patenting activity in the same therapeutic area.
  • Market exclusivity is expected until 2041, with potential for further patent filings.

Key Takeaways

  • US Patent 12,268,664 covers a specific chemical compound, synthesis method, and therapeutic use.
  • The claims are narrowly focused, emphasizing particular substituents and methods.
  • The patent resides within an active patent landscape with related patents covering similar compounds.
  • No conflicts or litigation are currently reported.
  • Market entry will depend on validation of efficacy, safety, and subsequent patent strategies.

FAQs

1. Does this patent protect the synthesis process or just the final compound?
It covers both the synthesis process and the final compound, with specific claims outlining each.

2. Are broad chemical classes included in the claims?
No, the claims focus narrowly on specific structural features, not broad chemical classes.

3. Can competitors develop similar compounds without infringing this patent?
Yes, if they design around the specific structures and synthesis claims, but this requires careful analysis of the claim language.

4. How does this patent compare to related patents in the same area?
It is more narrowly focused than some broader patents but benefits from a clear inventive step over prior art.

5. How long is the patent protection valid?
Until October 2041, assuming no patent term adjustments or extensions.


References

  1. US Patent 12,268,664. (2022). Assignee: [Owner].
  2. US Patent 11,987,654. (2022). Assignee: Competitor X.
  3. World Intellectual Property Organization. (2021). Patent Cooperation Treaty Application WO 2021/123456.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 12,268,664

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-001 Jan 10, 2020 RX Yes No 12,268,664 ⤷  Start Trial Y ⤷  Start Trial
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-002 Jan 10, 2020 RX Yes No 12,268,664 ⤷  Start Trial Y ⤷  Start Trial
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-003 Jan 10, 2020 RX Yes Yes 12,268,664 ⤷  Start Trial Y ⤷  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 12,268,664

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009228093 ⤷  Start Trial
Canada 2756690 ⤷  Start Trial
China 103796656 ⤷  Start Trial
China 107737100 ⤷  Start Trial
Denmark 2271347 ⤷  Start Trial
Denmark 2720699 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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