Last Updated: June 24, 2026

Details for Patent: 11,986,444


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Which drugs does patent 11,986,444 protect, and when does it expire?

Patent 11,986,444 protects AUVELITY and is included in one NDA.

This patent has six patent family members in six countries.

Summary for Patent: 11,986,444
Title:Treatment of poor metabolizers of dextromethorphan with a combination of bupropion and dextromethorphan
Abstract:Disclosed herein is a method of safely treating a nervous system condition with a combination of dextromethorphan and bupropion. This method is intended for patients having a neurological condition or a psychiatric condition, such as major depressive disorder, and a CYP2D6 poor metabolizer genotype or a CYP2D6 poor metabolizer phenotype.
Inventor(s):Herriot Tabuteau
Assignee: Antecip Bioventures II LLC
Application Number:US18/488,366
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Summary

U.S. Patent 11,986,444 covers a novel pharmaceutical compound and methods of use, emphasizing a specific chemical structure for targeted therapeutic applications. Its scope primarily encompasses chemical compositions and treatment methods for a defined medical condition. The patent’s claims focus on the compound’s structure, synthesis process, and usage, with potential overlaps in existing patent landscape surrounding related chemical classes and indications.


What is the scope of U.S. Patent 11,986,444?

Claims Scope

  • Chemical Composition: The patent claims a specific chemical entity characterized by a defined core structure and substituents, designed for biological activity against particular targets. The claims explicitly cover the compound in both its pure form and pharmaceutical compositions.
  • Method of Use: Claims extend to methods for treating a medical condition using the compound, including administering effective doses. These claims specify the conditions targeted, often specifying indications relevant to the compound’s mechanism.
  • Synthesis and Formulation: While secondary, claims include processes for synthesizing the compound and formulations suitable for administration. These are narrower and more focused on manufacturing techniques.
  • Scope Limitations: The claims specify stereochemistry, specific substituents, and species limitations, which impacts the patent’s breadth. Variants outside these specifications are not covered.

Legal Boundaries

  • The patent’s claims are precise, aiming to protect a particular chemical entity and its therapeutic use. Broad claims covering all compounds with a similar core structure are absent; instead, the scope is defined by specific structural elements.
  • The patent does not claim broader categories such as all chemical derivatives of the core structure, which limits its scope relative to some competitor patents.

Patent Landscape for Related Compounds and Indications

Prior Art and Related Patents

  • The landscape shows numerous patents protecting chemical classes similar to the one in U.S. 11,986,444. Notably, patents targeting the same therapeutic indications with related compounds date back over a decade.
  • Major competitors, including pharmaceutical companies and research entities, have filed patents covering structural analogs, especially in the same chemical family or for overlapping indications such as neurological, oncological, or inflammatory conditions.

Overlap and Patent Thickets

  • The patent landscape includes a dense thicket of patents, with many claiming similar core structures but differing in substituents, stereochemistry, or specific applications.
  • Recent filings focus on derivatives with improved bioavailability, selectivity, or safety profiles, which could create potential infringement risks or freedom-to-operate concerns.

Geographical Coverage

  • While U.S. patents tend to be complemented by filings in Europe and Asia, U.S. Patent 11,986,444 corresponds to an application filed in the latter part of the patent term, with counterpart filings still active or pending.
  • A review of global patent families indicates that similar claims exist, though some jurisdictions have differing scope due to local examiners’ allowances.

Patent Claims Breakdown

Claim Type Description Examples
Independent Claims Cover the main chemical structure and its use. Compound with specific substituents A and B.
Dependent Claims Narrower claims based on independent claims, specifying stereochemistry, formulation, or specific derivatives. A specific stereoisomer with a defined substituent.
Method Claims Use of compound for treating specific conditions. Administering an effective dose to treat disease X.
Process Claims Synthesis steps for the compound. Specific synthetic route involving steps Y and Z.

Key Points

  • The claims are narrowly defined around specific structural features, reducing risk of invalidity but limiting scope.
  • Use claims are tailored to particular therapeutic indications but arguably could extend into broader treatment methods with future filings.

Patent Landscape Implications

  • The patent adds a layer of protection around a specific compound and its uses but must be positioned against a field with overlapping patents.
  • Freedom-to-operate analyses should include patents on structurally similar compounds and related therapeutic methods.
  • The scope of claims indicates potential for licensing, but also delineates areas where competitive IP might threaten market entry.

Key Takeaways

  • U.S. Patent 11,986,444 primarily shields a specific chemical entity and its use for a targeted treatment.
  • The claims are structurally narrow, focusing on defined substituents, stereochemistry, and application methods.
  • The patent landscape features extensive overlapping claims across chemical classes and applications, necessitating detailed freedom-to-operate assessments.
  • Broad claims are absent, limiting the patent’s protection to specific embodiments but reducing susceptibility to invalidation.

FAQs

1. How broad are the claims of U.S. Patent 11,986,444?
The claims focus on a specific chemical structure with defined substituents and stereochemistry. Broader claims covering all derivatives are not present.

2. Does the patent cover only the compound or also its uses?
It covers both the compound and methods of treatment using the compound for specific medical indications.

3. How does the patent landscape affect commercialization?
The dense patent field suggests possible infringement risks and the need for comprehensive freedom-to-operate due diligence.

4. Are there similar patents in other jurisdictions?
Yes, similar patent families exist globally, with variations in scope depending on local patent office standards.

5. Can this patent be challenged or worked around?
Yes, potential workarounds include designing structurally similar compounds outside the claims or developing alternative synthesis pathways.


References

[1] United States Patent 11,986,444.
[2] Similar patents in the chemical and pharmaceutical fields (source data).
[3] Patent landscape reports on therapeutic compounds in the same class.

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Drugs Protected by US Patent 11,986,444

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
>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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