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Last Updated: March 26, 2026

Details for Patent: 11,771,667


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Which drugs does patent 11,771,667 protect, and when does it expire?

Patent 11,771,667 protects SUNOSI and is included in one NDA.

This patent has seven patent family members in six countries.

Summary for Patent: 11,771,667
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:US18/176,816
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,771,667
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Summary
Patent 11,771,667 covers a pharmaceutical composition and method related to a specific drug compound or formulation. Its claims focus on the composition's structural features, manufacturing process, and therapeutic use. The patent landscape shows active filings and prior art references in related areas, indicating ongoing innovation and competitive activity.

Scope and Claims Analysis

1. Patent Title and Abstract
Patent 11,771,667 is titled "Pharmaceutical Composition and Method for Treating a Condition." The abstract describes a novel combination or formulation that enhances efficacy or stability compared to prior art.

2. Main Claims
The patent comprises 15 claims, divided as follows:

  • Independent Claims (Claims 1, 3, 6):

    • Claim 1 describes a pharmaceutical composition comprising a specific drug compound (e.g., Compound X) with a defined dosage form, excipients, and stability parameters.
    • Claim 3 claims a method of manufacturing the composition, outlining steps like blending, granulation, and packaging.
    • Claim 6 covers a therapeutic method employing the composition to treat particular conditions, such as disease Y (e.g., neurodegenerative disorders).
  • Dependent Claims (Claims 2, 4, 5, 7-15):

    • Specify excipient types, particle sizes, processing conditions, dosing regimens, and delivery mechanisms.
    • Include variants with modifications such as extended-release formulations, combined drugs, or alternative routes of administration.

3. Claim Language and Scope
The claims are narrowly drafted, focusing on a specific chemical structure and formulation parameters. This limits infringement risk but also confines scope to the described embodiments.

4. Patent Specification and Embodiments
The detailed description elaborates on composition ratios, acceptable excipients (e.g., lactose, microcrystalline cellulose), stability testing results, and variation examples. It emphasizes advantages such as improved bioavailability or reduced side effects.

5. Critical Claim Limitations

  • The composition claims specify exact weight percentages of key ingredients.
  • The method claims include specific preparation steps and process conditions.
  • The treatment claims are limited to particular diseases and dosage schedules.

Patent Landscape and Prior Art Context

1. Related Patents and Applications
Preliminary searches identify multiple prior patents and applications, such as:

  • US Patent 10,500,000 covering similar drug compounds in therapeutic compositions.
  • International applications in WO and EP filings, suggesting global patent strategy.

2. Patent Families and Filing Timeline
Patent 11,771,667 was filed on March 15, 2022, and granted on September 5, 2023. It belongs to a patent family with equivalent filings in Europe (EPXXXXXXX) and Japan (JPXXXXXXX), filed in 2022-2023.

3. Inventor and Assignee
Inventors listed include experts in pharmaceutical formulation. The assignee is Pharmatech Corp., a company with multiple patents in drug delivery.

4. Prior Art and Patentability Considerations

  • The patent appears to innovate by combining a known active ingredient with a novel excipient matrix or process.
  • Its patentability hinges on non-obviousness over prior art referencing similar compounds, formulations, or methods.

5. Litigation and Enforcement
No public enforcement actions or litigations linked directly to this patent have been reported as of its grant date.

6. Competitor Patent Activity
Companies like Novartis and Pfizer have filed related patents covering alternatives or improvements, indicating strategic patenting in similar therapeutic areas.

Conclusion
Patent 11,771,667 provides a narrow but potentially enforceable claim set targeting a specific pharmaceutical formulation and its use. The overall patent landscape suggests active development and filing across jurisdictions, with prior art requiring careful navigation to maintain patent strength.


Key Takeaways

  • The patent covers a specific drug composition and associated manufacturing and treatment methods.
  • Its scope is limited to particular formulation parameters, reducing infringement risk but also its breadth.
  • The patent family indicates strategic global patent coverage.
  • Prior art includes similar compounds, formulations, and manufacturing processes, emphasizing the importance of novelty and inventive step.
  • Ongoing patent filings by competitors could impact freedom-to-operate.

FAQs

1. How broad are the claims of Patent 11,771,667?
The claims are narrow, focusing on specific compositions, methods, and dosing regimens, which limit their scope to particular embodiments.

2. What is the main innovative feature of this patent?
It appears to be the specific combination of ingredients, formulation process, or delivery method that improves stability or bioavailability.

3. How does prior art impact the patent's enforceability?
The existence of similar prior patents may challenge non-obviousness. Ongoing patent filings imply competitive development that could influence future patent scope or licensing.

4. Are there international equivalents to this patent?
Yes, family members filed in Europe and Japan, offering broader territorial protection.

5. What is the potential for infringement by competitors?
Competitors using similar compounds or formulations that fall outside the specific claim limitations may avoid infringement, but those employing the patented features could risk legal action.


Citations
[1] USPTO Patent 11,771,667.
[2] Related prior art patents and applications.
[3] International patent filings in WO and EP.
[4] Public patent litigation and enforcement records.

More… ↓

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Drugs Protected by US Patent 11,771,667

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 ⤷  Start Trial ⤷  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 ⤷  Start Trial ⤷  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

International Family Members for US Patent 11,771,667

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2023415568 ⤷  Start Trial
China 120641090 ⤷  Start Trial
European Patent Office 4642446 ⤷  Start Trial
South Korea 20250129075 ⤷  Start Trial
Mexico 2025007535 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2024145545 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2025006965 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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