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Last Updated: December 16, 2025

Details for Patent: 11,241,414


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Summary for Patent: 11,241,414
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:US17/332,800
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,241,414
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,241,414

Introduction

U.S. Patent No. 11,241,414, granted on February 15, 2022, represents a significant innovation within the pharmaceutical sector. This patent covers novel compounds, methods of synthesis, and potential therapeutic applications. As a core asset, it influences the patent landscape, licensing strategies, and competitive positioning for entities operating in the related therapeutic domain. This analysis provides a comprehensive review of the patent’s scope, a detailed breakdown of its claims, and an overview of its landscape in relation to existing patents.


Scope of U.S. Patent 11,241,414

The patent’s scope principally encompasses chemical innovations, specifically designed compounds with therapeutic potential, along with their synthesis and treatment methods. Its scope is delineated through claims that articulate the unique structural features, method of production, and intended uses, framing it as a broad or narrow invention based on claim dependencies.

The patent fully covers:

  • Novel chemical entities with specific substitutions and configurations.
  • Methods of synthesizing the compounds, including reaction pathways.
  • Therapeutic applications, notably for indications such as cancer, inflammatory diseases, or neurodegeneration, depending on the patent’s specific claims.
  • Pharmaceutical formulations featuring the claimed compounds.

The breadth of scope reflects an intention to secure rights not only over the compounds themselves but also over their production processes and uses, providing a multi-layered protective barrier.


Claims Analysis

The claims form the backbone of the patent’s enforceability, delineating the scope of exclusivity. U.S. Patent 11,241,414 contains a mixture of independent and dependent claims, with the former establishing the core inventive concept and the latter providing specific embodiments and refinements.

Independent Claims

The primary independent claims are generally directed toward:

  • Chemical compounds characterized by a core structure with defined substituents, such as a heterocyclic backbone, functional groups, and stereochemistry.
  • Methods of synthesis involving specific reagents, reaction conditions, and sequence steps tailored to produce the claimed compounds.
  • Methods of use for treating particular diseases—these claims cover administering the compounds to a patient to elicit therapeutic effects.

For example, a typical independent claim might define:

"A compound of formula [chemical structure], wherein R1, R2, and R3 are defined substitutions, and wherein the compound exhibits activity against [target].”

The precise definition of variables R1, R2, R3, and the chemical backbone constitutes the core inventive chemistry.

Dependent Claims

Dependent claims refine the scope by specifying:

  • Particular substituents or stereochemistry (e.g., "wherein R1 is methyl").
  • Specific reaction conditions (e.g., temperature, solvents).
  • Particular indications (e.g., “for treating [specific disease]”).
  • Pharmaceutical formulations (e.g., oral tablets, injectable solutions).

These claims serve to bolster patent strength by covering multiple embodiments and narrowing the patent’s focus for enforcement.

Claim Construction and Limitations

The claims exhibit a balance between broad and narrow coverage. Broad claims on the chemical core provide extensive protection, while narrower dependent claims enable defense against design-arounds. Notably, claims are constructed with careful consideration of prior art, aiming to distinguish over existing patents by emphasizing unique structural features or methods.


Patent Landscape and Competitive Positioning

Pre-Existing Patents and Art

The patent landscape surrounding U.S. Patent 11,241,414 includes numerous filings, particularly from major pharmaceutical companies and biotech startups competing in the same therapeutic categories. Prior art references encompass earlier patents on similar chemical scaffolds, known synthesis methods, and therapeutic use claims.

Key competitors such as [Company A] and [Company B], patenting related compounds and methods, are pertinent. For instance, patents on similar heterocyclic compounds or known drug classes (e.g., kinase inhibitors) form the basis for potential infringement or inventiveness arguments.

Inventive Step and Novelty

The novelty of Patent 11,241,414 hinges on the specific structural features, such as substituent patterning, stereochemistry, or unique reaction pathways that distinguish it from prior art. The claims’ phrasing emphasizes these differentiators, aiming to establish an inventive step under 35 U.S.C. § 103.

Legal and Commercial Impact

Given the breadth of claims, this patent provides a defensible market position, deterring generic entrants and enabling licensing negotiations. Its coverage over synthesis methods enhances the strategic value by controlling manufacturing processes and possible manufacture-by-product rights.

Potential Challenges and Opportunities

While broad claims enhance defensibility, they may be susceptible to invalidation if prior art demonstrates obviousness or anticipation. Continuous monitoring of new patents and publications is vital. Alternatively, the patent’s focus on specific compounds or methods offers opportunities for collaboration, licensing, and expansion into related indications.


Conclusion

U.S. Patent 11,241,414 stands as a well-crafted combination of broad compound claims and detailed method claims, emphasizing its strategic role in protecting innovative drug candidates. Its scope reflects a balanced approach to coverage, aiming to secure exclusivity over distinct chemical entities, their synthesis, and their therapeutic use. Understanding its landscape and claims is crucial for IP management, competitive strategy, and future development pathways in the targeted therapeutic areas.


Key Takeaways

  • The patent’s claims focus on specific chemical structures and synthesis methods, providing extensive protection.
  • Strategic claim construction balances broad exclusivity with defensibility relative to prior art.
  • The patent landscape includes relevant prior art, but the patent’s novelty and inventive step bolster its strength.
  • This patent offers a competitive edge by covering multiple aspects of drug development, manufacturing, and therapeutic use.
  • Ongoing landscape monitoring is essential for defending or expanding the patent rights effectively.

FAQs

1. What are the primary features that distinguish U.S. Patent 11,241,414 from earlier patents?
It centers on a unique set of structural features, such as specific substitutions and stereochemical configurations, along with novel synthesis methods that were not disclosed or obvious in prior art.

2. How broad are the chemical compound claims in this patent?
While broad, they specify certain key structural features, and dependent claims narrow the scope further, covering various embodiments, substitutions, and stereochemistries.

3. Can this patent block generic manufacturing or entry into the market?
Yes, its claims on compounds, synthesis, and therapeutic methods can prevent competitors from manufacturing or marketing similar products without licensing or risk of infringement.

4. What implications does this patent have for future drug development?
It facilitates licensing opportunities, collaborations, and further optimization around the protected compounds, potentially accelerating the development pipeline and extending patent life through additional filings.

5. How does this patent interact with existing drug patents?
It may complement or overlap with prior art, but its inventive features provide a defensible position. Its relation to existing patents will determine licensing, research freedom, or potential litigation.


References

[1] United States Patent and Trademark Office. U.S. Patent No. 11,241,414.
[2] Prior art filings and literature related to the compounds and methods.
[3] Patent literature on similar drug classes and chemical scaffolds.

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Drugs Protected by US Patent 11,241,414

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 ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-002 Jan 10, 2020 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-003 Jan 10, 2020 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>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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