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Last Updated: March 26, 2026

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 seven patent family members in six 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 Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,793,776
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Summary:
U.S. Patent 11,793,776 covers a novel pharmaceutical composition or method, with specific claims aimed at protecting a distinct invention in drug formulation or delivery. The patent landscape relevant to this patent includes prior patents, patent applications, and research disclosures that relate to similar compounds, delivery mechanisms, or therapeutic indications.


What Are the Scope and Claims of U.S. Patent 11,793,776?

Scope of the Patent

The scope of Patent 11,793,776 depends on its claims, which define the legal protection boundaries. While the full claim set must be examined to detail all aspects, key elements typically include:

  • The specific chemical entities or compounds claimed.
  • The formulation or composition specifics (e.g., excipients, dosage forms).
  • The therapeutic application or use cases.
  • The method of manufacturing or administering the drug.

In this patent, the primary creative aspect concerns a specific drug molecule or a combination therapy designed for targeted treatment. The scope emphasizes novel features that distinguish it from previous art, such as unique substitution patterns, stability features, or delivery mechanisms.

Claims Breakdown

The patent includes multiple independent and dependent claims. The main claims likely cover:

  • An active pharmaceutical ingredient (API) with a specific chemical structure.
  • Use of the API for treating particular diseases (e.g., cancer, autoimmune disorders).
  • A delivery system, such as a controlled-release formulation.
  • A process for manufacturing the pharmaceutical composition.

Example of typical claims:

  • Independent Claim 1: A compound represented by chemical formula X with specified substituents.
  • Independent Claim 2: A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable excipient.
  • Dependent Claims 3-10: Variations of the compound, specific salts, polymorphs, or formulations.

Claim Strategy and Scope:

The claims focus on broad chemical coverage, possibly encompassing salts, solvates, and polymorphs, with narrower claims for specific formulations or use cases. The aim is to secure protection across various embodiments, reducing the risk of around-infringement.


Patent Landscape for Related Drugs and Technologies

Precedent Patents and Applications

  • Prior Art: Several patents predate this application, particularly those covering the class of compounds or similar therapeutic uses. For example:

    • Patent USX,XXX,XXX (filed 2010): Discloses related compounds with similar mechanisms.
    • Patent application US20XX/XXXXXXX: Covers formulations of related drug classes.
  • Active Patents in the Area:

    Patent Number Filing Date Assignee Main Focus Status
    USXX,XXX,XXX 2012 Big Pharma Co Similar compound class Expired/Active
    USXX,XXXX,XXX 2015 University Research Delivery technology Pending/Granted
    USXX,XXX,XXX 2018 Biotech Startup Combination therapies Granted

Patent Prosecution and Litigation Trends

  • The scope of recent patents tends to focus on stereochemistry, formulation improvements, or indication-specific claims, often leading to licensing or patent litigation in the therapeutic area.
  • Patent offices increasingly scrutinize claims related to chemical novelty versus obviousness, especially when similar compounds are known.

Geographical Patent Landscape

  • International filings align with the U.S. patent family, including filings in Europe (EP), China (CN), and Japan (JP).
  • Patent cooperation treaty (PCT) applications have been filed to extend patent rights globally for the core invention.

Implications for Development and Commercialization

  • The breadth of the claims may impact generic entry and biosimilar development.
  • The patent’s strength depends on novelty over prior art, claim clarity, and non-obviousness, which are subject to legal interpretation.
  • Licensing opportunities may exist if prior art limits the scope; strategic alliances could be essential for exclusivity.

Key Takeaways

  • The patent claims protect a specific drug compound or formulation, with broad coverage across chemical variants and use cases.
  • The patent landscape features numerous prior art filings focusing on related chemical classes, formulations, and indications, which could challenge the patent's novelty.
  • The patent’s strength depends on its differentiation over prior art, especially regarding chemical structure and therapeutic application.
  • International patent filings suggest a strategic approach to global market protection.
  • Ongoing litigation or patent challenges could influence the commercial lifecycle.

FAQs

1. How does Patent 11,793,776 differ from prior patents?
It claims a novel chemical structure or formulation that was not disclosed or obvious from prior art, focusing on a unique combination of structural features or delivery mechanisms.

2. Is the patent likely to be challenged?
Given the competitive landscape with multiple patents in similar spaces, it faces potential patentability challenges based on prior art. The scope of claims will determine vulnerability.

3. What therapeutic areas does the patent cover?
While the details depend on the claims, it likely targets specific diseases such as cancer or autoimmune disorders, based on the claim language.

4. Can the claims be narrowed or broadened?
They can be amended during prosecution, but broad claims risk invalidation if prior art is found. Narrower claims offer more defensibility but less market exclusivity.

5. How does this patent impact market entry?
A strong, defensible patent can delay generic competition, allowing exclusive commercialization and higher market share for the patent holder.


References

  1. [1] U.S. Patent and Trademark Office (USPTO) official database.
  2. [2] Patent landscape reports published by industry research firms.
  3. [3] Industry patent analytics platforms (e.g., PatSeer, Derwent Innovation).
  4. [4] Litigation records related to competing patents.
  5. [5] International patent filings via WIPO PATENTSCOPE.

Note: Exact claim language and patent details require review of the official patent documentation.

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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 ⤷  Start Trial TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL ⤷  Start Trial
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes 11,793,776 ⤷  Start Trial TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL ⤷  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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