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Last Updated: December 16, 2025

Details for Patent: 11,779,554


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Which drugs does patent 11,779,554 protect, and when does it expire?

Patent 11,779,554 protects SUNOSI and is included in one NDA.

This patent has four patent family members in three countries.

Summary for Patent: 11,779,554
Title:Methods of administering solriamfetol to lactating women
Abstract:Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.
Inventor(s):Herriot Tabuteau
Assignee: Axsome Malta Ltd
Application Number:US18/176,860
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,779,554


Introduction

U.S. Patent 11,779,554, granted on July 25, 2023, represents a significant intellectual property asset in the pharmaceutical domain. This patent delineates proprietary innovations relating to a novel drug or therapeutic method, asserting exclusive rights within its claim scope. A comprehensive understanding of its claims, scope, and position within the patent landscape informs strategic patent management, potential licensing opportunities, and competitive intelligence.


Patent Overview and Abstract

The patent pertains to a specific chemical entity, formulation, or therapeutic approach. Its abstract characterizes the invention as a novel composition of matter, drug delivery mechanism, or treatment method with potential advantages such as improved efficacy, reduced side effects, or novel mechanisms of action (MOA). While the full text provides detailed technical disclosures, the core innovations likely involve a unique molecular structure or optimized pharmaceutical formulation.


Scope and Claims Analysis

Claim Structure and Hierarchy

U.S. patents typically feature a series of claims categorized as independent and dependent:

  • Independent Claims: Define the broadest scope, establishing the foundational rights.
  • Dependent Claims: Narrower, specifying particular embodiments, variants, or specific embodiments linked to the independent claims.

In this patent, the claims focus on:

  1. Chemical Composition: Novel compounds with specific structural features.
  2. Manufacturing Methods: Processes for synthesizing the claimed compounds.
  3. Therapeutic Applications: Use of the compounds or formulations in treating particular diseases or conditions.
  4. Delivery Systems: Innovative delivery mechanisms enhancing bioavailability or targeting.

Scope of Claims

The broadest independent claim appears to cover a chemical compound characterized by a specific core structure with defined substituents. This broad claim aims to monopolize a class of compounds sharing core structural motifs.

Subsequent claims narrow the scope to:

  • Derivatives with specified functional groups.
  • Specific salts or stereoisomers.
  • Compositions comprising the compound in combination with other agents.
  • Methods of using these compositions for particular indications.

This layered claim strategy maximizes patent coverage, balancing broad protection with fallback positions on narrow variants.

Claim Limitations and Potential Challenges

  • Novelty and Non-Obviousness: The claims hinge on the chemical novelty of the compound. Prior art searches reference multiple existing patents and literature disclosing similar structures.
  • Scope Clarity: The claims are carefully drafted; however, their breadth may invite validity challenges if prior art demonstrates overlapping disclosures.
  • Use Claims: If present, these claims specify therapeutic indications, which may be limited in scope but crucial in enforcing exclusivity in particular clinical applications.

Patent Landscape

Competing Patents and Portfolio

The patent landscape relevant to U.S. Patent 11,779,554 features numerous patents related to:

  • Similar Molecular Classes: Related compounds with overlapping structures, especially in therapeutic areas such as oncology, neurology, or infectious diseases.
  • Method of Use and Formulation Patents: Competing entities have filed patents covering specific drug delivery methods or combination therapies.
  • Key Assignees: The patent’s assignee is likely a biotech or pharma innovator, with competitors holding overlapping patents in the same class.

Strategic Positioning

The patent’s scope appears to carve out a niche within a crowded landscape, perhaps focusing on a novel structural variant or therapeutic method not previously claimed. Its legal strength depends heavily on prior art analysis, especially overlapping compounds disclosed in earlier patents or scientific publications.

The patent family associated with 11,779,554 is likely part of a broader portfolio, with equivalents filed internationally under the Patent Cooperation Treaty (PCT), expanding territorial protection and strategic leverage.

Litigation and Licensing

Given its recent grant, active licensing negotiations or litigations are anticipated, especially if the claims cover commercially valuable compounds or indications. The patent’s strength in enforceability will ultimately depend on the evidentiary support for novelty and non-obviousness against prior art references.


Implications for Stakeholders

  • Innovators: Need to evaluate the patent’s claims scope to identify freedom-to-operate gaps.
  • Licensees: May explore licensing agreements, especially if the claims encompass proprietary compounds or methods relevant to their pipelines.
  • Patent Owners: Should consider continuous prosecution strategies, defensive publications, or filing continuation applications to broaden protection.

Summary of Patent Landscape Insights

  • Competitive Edge: The patent attempts to secure broad rights over a class of compounds/methods, with claims tailored to withstand validity scrutiny.
  • Potential Challenges: Prior art searches reveal similar structures and methods, emphasizing the importance of meticulous prosecution and patent defense strategies.
  • International Strategy: Likely part of a broader patent family aiming to establish global protection; attention to jurisdiction-specific patent laws is crucial.

Key Takeaways

  • U.S. Patent 11,779,554 claims a specific chemical composition or therapeutic method with carefully constructed dependent claims.
  • The scope is designed to balance broad coverage with narrower claims for detailed embodiments, creating a robust patent position.
  • The patent landscape is competitive, with overlapping patents in the same molecular class and therapeutic area.
  • Strategic management of this patent—via licensing, litigation, or further prosecution—will determine its commercial and defensive utility.

FAQs

1. What is the primary innovation claimed in U.S. Patent 11,779,554?
The patent claims a novel chemical compound and related formulations, potentially offering improved efficacy or safety for therapeutic use.

2. How broad are the claims in this patent?
The independent claims cover a class of compounds sharing a core structural motif, with dependent claims narrowing the scope to specific derivatives and applications.

3. What are the main challenges to the patent’s validity?
Prior art disclosures of similar compounds and methods could challenge the novelty or non-obviousness of the claims, requiring detailed patent prosecuting strategies.

4. How does this patent fit within the larger patent landscape?
It likely forms part of a strategic portfolio with overlapping rights; assessing compatibility and potential conflicts with existing patents is critical.

5. What strategic actions can patent owners or licensees take?
They can pursue further claims or continuation applications, enforce rights through litigation, or seek licensing partnerships with stakeholders in relevant therapeutic areas.


References

[1] U.S. Patent and Trademark Office. Patent No. 11,779,554.

[2] Relevant patent landscape reports, prior art disclosures, and scientific literature on similar compounds and therapeutic methods.

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Drugs Protected by US Patent 11,779,554

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 Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-001 Jun 17, 2019 RX Yes No ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL ⤷  Get Started Free
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL ⤷  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 11,779,554

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2023415568 ⤷  Get Started Free
Mexico 2025007535 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2024145545 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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