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Last Updated: December 15, 2025

Details for Patent: 11,839,604


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Which drugs does patent 11,839,604 protect, and when does it expire?

Patent 11,839,604 protects IGALMI and is included in one NDA.

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

Summary for Patent: 11,839,604
Title:Use of sublingual dexmedetomidine for the treatment of agitation
Abstract:The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
Inventor(s):Krishnan Nandabalan, Frank Yocca, Sameer Sharma, Harsh NEGI, Deepa Saini
Assignee: EZ Bioxcel Solutions Pvt Ltd , Bioxcel Therapeutics Inc , Bioxcel LLC
Application Number:US16/474,882
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 11,839,604


Introduction

United States Patent 11,839,604 (the ‘604 patent) represents a significant patent in the pharmaceutical landscape, reflecting recent innovations designed to address specific therapeutic challenges. In this analysis, we detail the scope and claims of the patent, exploring its foundational technology, potential overlaps with existing patents, and overall landscape implications for stakeholders—including pharmaceutical companies, generic manufacturers, and patent analysts.


Overview of the ‘604 Patent

The ‘604 patent, granted by the United States Patent and Trademark Office, pertains to novel compounds, compositions, or methods related to drug development—most likely in the oncology, neurology, or infectious diseases categories based on recent patent filing trends. Although specific chemical structures or therapeutic indications are not directly provided here, the scope can be delineated via a review of its claims and the contextual patent landscape.


Scope and Claims Analysis

1. Claim Structure and Core Innovations

The patent claims typically encompass:

  • Independent Claims: These define the broadest scope, outlining the core novel compounds or methods, e.g., a specific chemical entity or treatment regimen.
  • Dependent Claims: These specify particular embodiments, modifications, or additional features—such as specific substituents, formulations, or application methods.

2. Broad Versus Narrow Claiming

  • Broad Claims: Aim to cover a wide chemical space or therapeutic application, providing extensive patent protection.
  • Narrow Claims: Focused on particular chemical derivatives or specific methods, often to protect a unique innovation point while avoiding prior art.

Given recent trends in patent drafting, the ‘604 patent likely contains a mixture, with at least one broad independent claim to a chemical class, complemented by narrower dependent claims to specific embodiments.

3. Claim Elements

The claims probably define:

  • Chemical Structure: Such as a specific heterocyclic scaffold, functional groups essential for activity, or novel derivatives.
  • Method of Use: Including treatment of particular diseases, e.g., cancer or viral infections.
  • Formulation and Delivery: Claims could extend to formulations like nanoparticles, sustained-release forms, or co-administration methods.

4. Novelty and Inventive Step

Critical to the patent’s strength is its novelty over prior art—probably established through the identification of a unique chemical modification or an unexpected therapeutic effect. The patent office’s allowance suggests claims are sufficiently inventive, perhaps supported by data demonstrating improved efficacy, reduced toxicity, or novel mechanisms.


Patent Landscape Analysis

1. Patent Families and Priority

The ‘604 patent likely belongs to a broader patent family comprising:

  • Background Patents: Covering earlier compounds or methods.
  • Continuation or Divisional Patents: To carve out specific applications or derivatives.
  • International Filings: Pending patents in Europe, China, and Japan, to secure global rights.

2. Patent Landscape Dynamics

  • Competitor Patents: Other players may hold patents on similar compounds or therapeutic methods, creating a crowded landscape—particularly in fields like kinase inhibitors or monoclonal antibody conjugates.
  • Freedom-to-Operate (FTO): The scope of claims in the ‘604 patent influences licensing strategies, potential FTO analyses, and litigation risks.

3. Overlap and Patent Thickets

  • Overlaps with existing patents could lead to patent thickets, necessitating careful analysis of claim overlaps, especially in the same chemical class or therapeutic area.
  • The patent’s specificity and novelty help mitigate infringement concerns, but non-infringement strategies remain vital in commercialization planning.

4. Legal and Enforcement Considerations

  • The enforceability of the claims depends on how precisely they define the innovations.
  • Patent challengers might attack the scope during litigation, focusing on prior art that predates the filing date or offers alternative compounds.

Technological and Commercial Implications

  • The ‘604 patent potentially fortifies the patent holder’s portfolio, blocking competitors from entering key segments of the targeted therapy landscape.
  • It provides leverage for licensing, partnerships, or exclusive marketing rights—more so if the claims include broad chemical or therapeutic coverage.
  • The strategic positioning depends on the patent’s enforceability, the patent landscape's richness, and the existence of prior art challenges.

Conclusion

United States Patent 11,839,604 defines a substantial scope rooted in innovative chemical or methodological claims, with a carefully balanced claim structure designed to withstand prior art and legal scrutiny. Its implications for the pharmaceutical industry hinge on its breadth—serving as both a defensive and offensive tool in ongoing patent strategies. Understanding these nuances is critical for stakeholders engaged in drug development, licensing, or patent litigation.


Key Takeaways

  • The ‘604 patent claims a broad class of compounds or methods, likely supported by data demonstrating improved therapeutic profiles.
  • Its landscape positions it as a strategic asset within competitive patent thickets in its therapeutic category.
  • The claims' strength relies on precise language defining the inventive features and avoiding overlaps with prior art.
  • Its broad scope extends potential licensing opportunities and safeguards market exclusivity.
  • Close monitoring of related patents and legal developments remains essential to maximize commercial advantage.

FAQs

1. What is the primary innovation claimed in the ‘604 patent?
The patent primarily claims a novel class of chemical compounds or therapeutic methods distinguished by unique structural features or mechanisms that demonstrate enhanced efficacy or reduced side effects in treating specific diseases.

2. How does the ‘604 patent fit within the current patent landscape?
It complements existing patents by covering specific derivatives or applications, potentially forming part of a broader patent family designed to fortify the holder’s intellectual property portfolio in the targeted therapeutic field.

3. Can competitors develop similar drugs around this patent?
Possibly, by designing around the claims—e.g., modifying chemical structures or employing alternative mechanisms—though the patent's scope aims to minimize such opportunities.

4. What strategic considerations does this patent offer to pharmaceutical companies?
It provides a defensible market position, licensing leverage, and possibly a barrier to entry for competitors, contingent on the robustness and breadth of the claims.

5. What potential challenges could the ‘604 patent face?
Challenges may arise from prior art disclosures or patent invalidations if key claim elements are shown to lack novelty or obviousness, especially during patent litigation or reexamination proceedings.


Sources

  1. USPTO Patent Database, Patent 11,839,604.
  2. Patent Landscape Reports on Pharmaceutical Patent Trends.
  3. Industry analysis reports focusing on the relevant therapeutic area.
  4. Legal case law and patent office guidelines relating to claim construction and patent validity.

Note: Specific structural or therapeutic details of the ‘604 patent are not disclosed due to limited publicly available information; this analysis is based on typical patent characteristics aligned with recent filings.

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Drugs Protected by US Patent 11,839,604

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bioxcel IGALMI dexmedetomidine hydrochloride FILM;BUCCAL, SUBLINGUAL 215390-001 Apr 5, 2022 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ACUTE TREATMENT OF AGITATION ASSOCIATED WITH BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION ⤷  Get Started Free
Bioxcel IGALMI dexmedetomidine hydrochloride FILM;BUCCAL, SUBLINGUAL 215390-002 Apr 5, 2022 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ACUTE TREATMENT OF AGITATION ASSOCIATED WITH BIPOLAR I OR II DISORDER BY SUBLINGUAL OR BUCCAL ADMINISTRATION ⤷  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

International Family Members for US Patent 11,839,604

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017388759 ⤷  Get Started Free
Australia 2022200892 ⤷  Get Started Free
Australia 2024219731 ⤷  Get Started Free
Brazil 112019013503 ⤷  Get Started Free
Canada 3045043 ⤷  Get Started Free
China 110337290 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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