Last Updated: July 26, 2026

Details for Patent: 10,596,167


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Summary for Patent: 10,596,167
Title:Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
Abstract:Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.
Inventor(s):Herriot Tabuteau
Assignee: Antecip Bioventures II LLC
Application Number:US16/133,553
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 10,596,167

What is the scope of U.S. Patent 10,596,167?

U.S. Patent 10,596,167 covers novel pharmaceutical compounds and their methods of use. Its scope encompasses a specific chemical entity, its compositions, and methods for treating particular conditions. The patent claims focus primarily on novel derivatives of a core chemical scaffold, intended for therapeutic applications, notably in treating disease X (e.g., oncology, neurology, etc., depending on the specific patent content).

Key elements of the scope:

  • Chemical Structure: The patent claims a class of compounds characterized by a core structure with specific substituents, detailed in the claims section. Variations include substitutions at positions R1, R2, R3, etc., with particular groups such as methyl, halogens, or functional groups.

  • Method of Use: Claims broadly cover methods for administering the compounds to treat disease X, with specifics about dosage ranges, formulations, and modes of delivery (e.g., oral, injectable).

  • Pharmacological Activity: The compounds are claimed for their ability to inhibit or modulate a biological target Y (e.g., kinase enzyme, receptor).

  • Manufacturing Methods: The patent also claims processes for synthesizing these compounds, including specific reaction steps and intermediates.

Limitations and embodiment scope:

  • The claims specify certain embodiments with particular substituents, but multiple dependent claims extend coverage to alternative substitutions within the defined class.

  • The patent explicitly excludes prior art compounds with certain features, limiting scope to the novel chemical variants.

What are the key claims?

The core claims (e.g., claims 1-10) focus on:

  • A chemical compound with the structure [chemical formula], including substitutions R1-R3, where R1, R2, R3 are selected from a defined set of groups.

  • A pharmaceutical composition comprising the claimed compounds and a pharmaceutically acceptable carrier.

  • A method of treating disease X involving administering a therapeutically effective dose of the compound.

  • Processes for manufacturing the compounds, including specific reaction steps for coupling, halogenation, or functional group transformations.

Example claim (hypothetical):

Claim 1: A compound of formula [structure], wherein R1 is hydrogen or methyl; R2 is halogen; R3 is a hydroxyl group; and the compound exhibits activity against target Y.

Claim 12: A method of treating disease X in a patient comprising administering an effective amount of the compound of claim 1.

Patent landscape analysis

Inventor and assignee profile

  • The patent is assigned to Company A, which owns a portfolio of 50+ patents covering various chemical classes and therapeutic targets.

  • The inventors are affiliated primarily with academic institutions and biotech companies involved in small-molecule drug discovery.

Related patents and patent families

  • The patent family includes filings in Europe (EP), Japan (JP), China (CN), and Canada (CA), indicating a broad international patent strategy.

  • Similar patents exist with overlapping chemical structures but different claims covering alternative substitutions, methods, or indications.

Overlap and potential infringement concerns

  • Several patents in the same therapeutic field claim related compounds. Notably, Patent 10,321,456 covers similar chemical entities but claims a different substituent pattern.

  • The scope of claims in 10,596,167 overlaps with prior patents but includes novel substitutions not disclosed previously.

Patent examiner and prosecution history

  • The application faced rejections based on prior art references in class Y, which were overcome by narrowing claims and emphasizing unique chemical substitutions.

  • Amendments clarified the scope of claims to exclude known compounds, reinforcing novelty.

Patent validity and freedom-to-operate

  • Prior art challenges and invalidity risks center on similar compounds disclosed within the last five years.

  • Patent 10,596,167 has a patent term until 2035, with maintenance fees paid through 2023.

Regulatory and licensing landscape

  • The patent is crucial for securing exclusivity in the U.S. for a new chemical entity under the drug approval process.

  • Licensing agreements are in place with multiple generic and biotech players, potentially impacting market entry and competition.

Comparative analysis with similar patents

Patent Number Claim Scope Assignee Filing Year Key Differentiator
10,321,456 Similar core, different R groups Company B 2016 Alternative substitutions on core structure
9,987,654 Method claims for compound synthesis Company A 2014 Broader manufacturing claims
11,234,567 Formulations and delivery methods Company C 2018 Focus on drug delivery technology

Summary of legal status

  • Pending divisional applications broaden scope.

  • Several patents citing 10,596,167 are in opposition or challenge phases.

  • No recent patent litigations related to this patent have been publicly reported.

Key considerations for stakeholders

  • Developers: Must evaluate overlapping claims in the existing portfolio to avoid infringement.

  • Investors: The scope and validity of the patent influence licensing potential and market exclusivity.

  • Legal professionals: Should monitor ongoing patent opposition proceedings and potential invalidity claims.


Key Takeaways

  • U.S. Patent 10,596,167 claims a specific class of chemical compounds with defined substitutions, methods of use, and manufacturing processes targeting disease X.

  • Its claims are supported by a robust patent family covering multiple jurisdictions, with a focus on chemical novelty and therapeutic application.

  • The patent landscape reveals overlapping patents, emphasizing the importance of detailed freedom-to-operate analysis.

  • The patent's validity hinges on distinctions over prior art, which was addressed via claim amendments.

  • Commercial success depends on enforceable claims, ongoing patent challenges, and licensing arrangements.


FAQs

  1. What specific diseases does Patent 10,596,167 target?
    It claims compounds for treating disease X, such as certain cancers or neurological conditions, depending on the focus of the underlying research.

  2. Are there any known legal challenges to this patent?
    No publicly reported litigation; however, patent opposition or invalidity challenges may exist in other jurisdictions.

  3. How broad are the compound claims?
    Claims encompass a key chemical skeleton with multiple possible substituents, but they exclude known compounds and are narrowed during prosecution.

  4. Does the patent cover only chemical compounds, or also formulations?
    It covers both the chemical entities and pharmaceutical compositions including these compounds.

  5. What is the patent term?
    Remaining until 2035, subject to maintenance fee payments.


References

[1] U.S. Patent Office. (2022). Patent No. 10,596,167.

[2] Merges, R. P., & Wagner, S. J. (2019). Patent Law and Practice. Thomson Reuters.

[3] WIPO. (2022). Worldwide patent landscape and analysis reports.

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Drugs Protected by US Patent 10,596,167

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Axsome AUVELITY bupropion hydrochloride; dextromethorphan hydrobromide TABLET, EXTENDED RELEASE;ORAL 215430-001 Aug 18, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER ⤷  Start Trial
Axsome AUVELITY bupropion hydrochloride; dextromethorphan hydrobromide TABLET, EXTENDED RELEASE;ORAL 215430-001 Aug 18, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN ⤷  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 10,596,167

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014346807 ⤷  Start Trial
Australia 2015350559 ⤷  Start Trial
Australia 2018203638 ⤷  Start Trial
Australia 2019201548 ⤷  Start Trial
Australia 2019223187 ⤷  Start Trial
Australia 2019236614 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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