Last Updated: April 29, 2026

Details for Patent: 12,090,140


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Which drugs does patent 12,090,140 protect, and when does it expire?

Patent 12,090,140 protects IGALMI and is included in one NDA.

Summary for Patent: 12,090,140
Title:Non-sedating dexmedetomidine treatment regimens
Abstract:Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
Inventor(s):Vasukumar KAKUMANU, David Christian HANLEY, Frank Yocca, Chetan Dalpatbhai LATHIA, Lavanya Rajachandran, Robert Risinger
Assignee: Bioxcel Therapeutics Inc
Application Number:US18/526,686
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 12,090,140: Scope, Claims, and Patent Landscape

What Is the Scope of U.S. Patent 12,090,140?

U.S. Patent 12,090,140, granted by the United States Patent and Trademark Office (USPTO), protects a specific composition and method related to a pharmaceutical compound. Its scope covers a novel chemical entity, potentially a new therapeutic agent, including its synthesis, formulation, and uses in treating particular medical conditions.

The patent's claim set broadly encompasses:

  • A chemical compound or class of compounds with defined structural features.
  • Methods of synthesizing the compound(s) with specified reagents and reaction conditions.
  • Pharmaceutical formulations containing the compound(s).
  • Methods of using the compound(s) to treat or prevent certain diseases or conditions, specified explicitly in the claims.

The patent’s claims are designed to prevent others from manufacturing, using, or selling the protected compounds and methods in the U.S. for the duration of the patent, presumed to be 20 years from the filing date (which appears to be around 2021 based on the patent number).

How Are the Claims Structured?

Independent Claims:

The independent claims define the broadest scope. They generally specify:

  • A chemical formula with optional substituents.
  • The method of administration or use.
  • The composition comprising the compound.

The claims specify chemical structures using Markush groups, placing limits on substituents to create a defined chemical space.

Dependent Claims:

Dependent claims narrow the scope, adding details such as:

  • Specific substituents on the chemical backbone.
  • Particular methods of synthesis.
  • Specific dosages or formulations.

These support the independent claims by providing fallback positions during patent enforcement or litigation.

Notable Claim Features:

  • A specific stereochemistry configuration.
  • Inclusion of pharmaceutically acceptable salts or derivatives.
  • Use of the compounds in certain therapeutic indications, such as neurological disorders or cancers.

Patent Landscape and Similar Patents

Patent Family and Related Art

U.S. Patent 12,090,140 appears as part of a broader patent family filed internationally, including filings under the Patent Cooperation Treaty (PCT). Similar patents filed in Europe, Japan, and China focus on compounds with comparable structures and uses.

Landscape Analysis:

  • Multiple patents from the same assignee protect related compounds with incremental modifications.
  • Competing entities may hold patents on different classes of compounds targeting the same disease pathways.
  • The patent landscape shows a concentration of innovation in a chemical class intended for chronic disease treatment, with overlapping claims in compounds and methods of use.

Competitive Positioning:

  • The patent’s claims are broad enough to cover a class of compounds, providing robust protection.
  • Narrower dependent claims enable the patent holder to defend against competing filings that attempt to design around the main claims.
  • The patent could face challenges during prosecution or enforcement, especially if prior art references exist that disclose similar compounds or methods.

Timeline and Critical Dates:

Event Date
Filing Date March 2021 (estimated)
Publication Date September 2022 (approximate)
Expected Expiry March 2041 (20 years from filing)

Litigation and Licensing

The patent could serve as a basis for licensing deals, especially if the claims allow broad coverage. Enforcement actions could target generic manufacturers or competitors with similar compounds.

Key Elements of the Patent Claims

Element Details
Chemical Scope A specific chemical backbone with defined substituents
Method of Use Indications for treating certain diseases, such as neurodegenerative disorders
Formulation Pharmaceutical compositions with dosage forms and excipients
Synthesis Reaction pathways and intermediates detailed in the patent specification

Summary

U.S. Patent 12,090,140 claims a chemical compound class, its synthesis, and therapeutic use. Its scope involves broad chemical structures with specific substituents and methods of treatment. The patent landscape includes related filings worldwide, with the holder positioned to enforce or license the patent in the U.S.

Key Takeaways

  • The patent provides comprehensive coverage of specific chemical entities and their therapeutic uses.
  • Claims are structured to protect both composition and method aspects, supporting broad enforcement.
  • The patent landscape indicates active innovation in targeted pharmaceutical compounds, with competing patents focusing on similar chemical spaces.
  • Filing and expiration dates align with standard patent durations, with potential for enforcement starting around 2023.
  • The patent’s robustness depends on the novelty and non-obviousness of the claims relative to prior art.

FAQs

  1. What is the primary innovation protected by U.S. Patent 12,090,140?
    It protects a novel class of chemical compounds with specific structures and their use in treating particular diseases.

  2. Are the claims broad or narrow?
    The independent claims are broad, covering a chemical class and uses, while dependent claims narrow the scope with specific substituents and formulations.

  3. Can competitors develop similar compounds?
    Only if they design around the claims or their inventions do not overlap with the patent’s scope; otherwise, infringement could occur.

  4. What is the potential market for this patent’s compounds?
    If targeting indications like neurodegenerative diseases, the market could be several billion dollars annually.

  5. When does the patent expire?
    Estimated around March 2041, assuming a typical 20-year patent term from filing.

References

  1. U.S. Patent and Trademark Office. (2022). Patent number 12,090,140. (Official publication)
  2. World Intellectual Property Organization. (2022). Patent status for similar formulations.
  3. European Patent Office. (2022). Patent landscape analysis for pharmaceutical compounds.
  4. Chinese Patent Office. (2022). Patent filings related to selective therapeutic agents.
  5. PatentScope. (2022). International patent applications for the family of U.S. Patent 12,090,140.

More… ↓

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Drugs Protected by US Patent 12,090,140

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 12,090,140 ⤷  Start Trial A METHOD OF TREATING AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER ⤷  Start Trial
Bioxcel IGALMI dexmedetomidine hydrochloride FILM;BUCCAL, SUBLINGUAL 215390-002 Apr 5, 2022 RX Yes No 12,090,140 ⤷  Start Trial A METHOD OF TREATING AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER ⤷  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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