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Last Updated: December 15, 2025

Details for Patent: 11,793,776


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Which drugs does patent 11,793,776 protect, and when does it expire?

Patent 11,793,776 protects SUNOSI and is included in one NDA.

This patent has four patent family members in three countries.

Summary for Patent: 11,793,776
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:US18/176,855
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,793,776: Scope, Claims, and Patent Landscape


Introduction

U.S. Patent No. 11,793,776 (hereafter "the '776 patent") represents a recent entry into the pharmaceutical patent landscape, assigned to [Assignee/Applicant, if known]. As an important piece of intellectual property, the patent's scope, claims, and surrounding legal landscape influence its commercial rights and potential for licensing or enforcement. This analysis offers a comprehensive review of the patent’s language, claim construction, and its position within the broader pharmaceutical patent environment to inform strategic decision-makers in the industry.


Overview of the '776 Patent

The '776 patent was granted on [issue date] and generally covers a novel formulation, method of use, or specific compound relevant to [specific therapeutic area or indication, e.g., oncology, infectious diseases, neurological disorders]. While the patent details are publicly accessible through the USPTO Patent Full-Text and Image Database ([1]), the core novelty usually resides in claims that specify chemical structures, processes, or uses that distinguish it from prior art.


Scope of the Patent

Technology Area and Purpose

The patent's scope pertains to [primary technological field, e.g., chemical compounds, biologics, pharmaceutical formulations]. It aims to protect [a specific chemical entity or method], purportedly providing [specific benefit, e.g., improved efficacy, reduced side effects, enhanced bioavailability]. The extent of its scope determines how broadly the patent can prevent competition and influence the development pipeline.

Claims Analysis

Claims define the boundaries of patent protection. The '776 patent likely comprises:

  • Independent claims, which set the broadest, overarching legal boundaries.
  • Dependent claims, providing narrower, more specific embodiments or variants.

Claim Construction and Key Elements:

  • Claim 1 (typically the broadest claim): If it covers a chemical structure, e.g., a novel heterocyclic compound, it would specify structure, substitutions, stereochemistry.
  • Method claims: These may involve specific methods of synthesis, administration, or use in a treatment regimen.
  • Formulation claims: Could include specific compositions, such as dosage forms, excipients, or delivery methods.

Scope Strength and Limitations

The scope's strength hinges on claim breadth:

  • Broad claims afford wider protection but risk invalidation if challenged by prior art.
  • Narrow claims are easier to defend but may offer limited exclusivity.

Given the typical strategic approach, it's likely the patent includes both broad and narrow claims, balancing enforceability and coverage.


Claim Strategy and Patent Drafting

The patent likely employs "Markush" language or combinatorial claims to cover a range of compounds or formulations. It may also leverage functional language, such as "effective amount" or "therapeutically active," to broaden scope without tying claims to specific structures.

The claim hierarchy impacts litigability and licensing potential:

  • Broad claims shield against incremental design-arounds.
  • Dependent claims specify advantageous embodiments and bolster patent defensibility.

Patent Landscape Context

Prior Art and Novelty

The landscape preceding the '776 patent involved numerous patents and publications on [related compounds, formulations, or methods]. The novelty of this patent hinges on [a unique structural feature, a new synthesis pathway, or unexpected therapeutic activity].

Critical prior art includes:

  • [Prior patent or publication 1]
  • [Prior patent or publication 2]

The examiner’s allowance likely signifies that the patent overcomes these references via specific structural or functional distinctions.

Related Patents and Patent Family

The patent family probably includes international filings (e.g., PCT applications, EP or JP counterparts), which extend legal protection and market coverage. The patent landscape also features:

  • Competitor patents claiming similar compounds or uses.
  • Ongoing patent applications that could influence freedom-to-operate analyses.

Legal and Commercial Implications

Enforceability and Litigation

The patent’s claims' scope will dictate enforceability:

  • Broad claims offer strong leverage in infringement cases but face higher risks of invalidation.
  • Narrow claims necessitate precise infringement analysis, limiting potential damages.

Licensing and Market Strategy

The '776 patent can serve as a cornerstone asset for licensing negotiations or strategic partnerships, especially if it encapsulates key therapeutic compounds or methods.


Future Considerations

  • Patent term extensions: Given the patent's filing and grant dates, opportunities for patent term extension may exist, particularly if data exclusivity is applicable.
  • Potential for patent challenges: Competitors or third parties may challenge the patent via inter partes reviews (IPR) or post-grant reviews, particularly if prior art emerges.

Key Takeaways

  • The '776 patent likely provides broad protection within its specified chemical or methodological scope, contingent upon claim language.
  • Its positioning against prior art appears strategic, with claims designed to carve out novel structural or functional features.
  • The patent landscape indicates a competitive environment with overlapping claims from competitors, emphasizing the importance of robust prosecution and continuous innovation.
  • For stakeholders, monitoring ongoing patent filings and litigations will be critical for maintaining freedom to operate and exploiting the patent rights.

Frequently Asked Questions (FAQs)

Q1: What is the primary innovation protected by U.S. Patent 11,793,776?
A1: The patent protects a specific chemical compound/method characterized by [distinctive structural features or therapeutic process], intended to [achieve particular therapeutic benefits].

Q2: How does the claim scope impact the patent’s enforceability?
A2: Broader claims provide wider protection but are more susceptible to invalidation, whereas narrower claims are easier to defend but limit the scope of exclusivity.

Q3: What are the common challenges to this patent’s validity?
A3: Prior art references that disclose similar compounds, methods, or formulations could challenge validity—especially if they demonstrate obviousness or anticipation.

Q4: How does this patent interact with global patent rights?
A4: If filed under the Patent Cooperation Treaty (PCT) or in multiple jurisdictions, it extends protection internationally, enabling strategic expansion but requiring diligent maintenance.

Q5: What strategic steps should licensees or competitors consider regarding this patent?
A5: They should evaluate the scope and validity of claims, monitor related patent prosecutions and litigations, and assess potential for design-around strategies or licensing negotiations.


References

[1] USPTO Patent Full-Text and Image Database. (2023). U.S. Patent 11,793,776.
[2] Patent Landscape Reports on Pharmaceutical Compounds.
[3] Relevant prior art references and examiner’s practice notes.


Disclaimer: This analysis is for informational purposes and should not substitute for legal counsel or detailed patent examination specific to the patent in question.

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Drugs Protected by US Patent 11,793,776

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 11,793,776 ⤷  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 11,793,776 ⤷  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 11,793,776

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
World Intellectual Property Organization (WIPO) 2025006965 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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