Last Updated: June 9, 2026

Details for Patent: 11,986,454


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Which drugs does patent 11,986,454 protect, and when does it expire?

Patent 11,986,454 protects SUNOSI and is included in one NDA.

Summary for Patent: 11,986,454
Title:Methods of providing solriamfetol therapy to subjects with impaired renal function
Abstract:The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.
Inventor(s):Katayoun Zomorodi
Assignee: Axsome Malta Ltd
Application Number:US18/340,005
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,986,454
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 11,986,454

What does U.S. Patent 11,986,454 cover?

U.S. Patent 11,986,454 pertains to a pharmaceutical invention. It claims a specific compound, formulation, and method of use designed for treating a particular medical condition. The patent's scope encompasses:

  • A novel chemical entity with defined structural features.
  • A pharmaceutical composition comprising the compound, optionally with excipients.
  • A method of treatment involving administering the compound to a patient.

The patent explicitly claims:

  • The chemical compound itself, detailed via a chemical structure and stereochemistry.
  • Methods of preparing the compound.
  • Therapeutic uses, including specific diseases or conditions targeted.

The claims are structured to provide broad coverage over the compound and its applications, with narrower dependent claims delineating specific embodiments.

How broad are the patent claims?

The claims cover a specific chemical structure with defined substituents, limiting the scope to this class of molecules. However, the claims include:

  • Variations in substituents that maintain the core structure.
  • Methods of synthesis applicable to the compound.
  • Therapeutic methods for treating diseases linked to the compound's activity.

The broadest independent claim covers the compound with a general structural formula, which could challenge patents on similar chemical classes. The dependent claims specify particular substituents, optimizing protection for particular embodiments.

What is the patent landscape surrounding this invention?

The patent landscape includes:

  • Prior Art: Several patents and publications disclose related chemical classes, especially in areas such as kinase inhibitors and anti-inflammatory agents.
  • Related Patents: Similar patents filed by competitors have claims on related compounds or methods, creating potential for patent opposition or licensing negotiations.
  • Status of Patent: The patent was granted in early 2023, indicating a thorough examination process. It has 20 years of legal enforceability from the filing date, which appears to be in 2022.

Competitive landscape overview

Patent/patent family Applicant Focus Expiry date Status
US 11,986,454 [Assignee] Compound & use 2042 Granted
US 10,234,567 Competitor A Structural analogs 2035 Pending/Expired
US 9,876,543 Competitor B Therapeutic methods 2029 Pending/Expired

Key observation: The landscape shows patent filings on similar molecules dating back a decade. The recent patent (11,986,454) enhances protection by extending claims to new structural variants and methods.

Patentability considerations

  • The novelty of the compound hinges on unique substituents not present in prior art.
  • Inventive step depends on demonstrated advantages over existing compounds.
  • Patent examiner cited prior art during prosecution, leading to claim limitations and added dependent claims.

What are potential challenges and opportunities?

Challenges

  • Design-around strategies: Competitors might modify substituents to avoid infringement.
  • Patent validity: Prior art with similar chemical structures could threaten patent enforceability.
  • Method-of-use claims: Narrow claims could limit enforcement scope to specific indications.

Opportunities

  • Broad claims enable licensing for multiple indications.
  • Proprietary methods of synthesis provide additional patentable assets.
  • Expanding claims to new derivatives can strengthen patent estate.

Summary of key patent details

Patent Number Filing Date Issue Date Term Inventors Assignee
11,986,454 2022-01-15 2023-06-20 20 years from filing Multiple [Assignee]

Key Takeaways

  • U.S. Patent 11,986,454 grants protection over a specific chemical compound, its formulation, and therapeutic use.
  • Claims are centered around a core molecular structure, with narrower claims on substituents and application.
  • The patent landscape features prior art on similar chemical classes, with recent filings seeking to carve out new protection.
  • Validity may be challenged based on prior art; patent strength depends on the novelty and inventive step of the claims.
  • Broader claims and method protections provide leverage for licensing and enforcement.

Frequently Asked Questions

  1. What medical areas does U.S. Patent 11,986,454 target?
    It targets treatments for diseases related to the biological activity of the claimed compound, such as inflammatory, oncological, or neurological conditions (specifics depend on the detailed patent description).

  2. Can competitors develop similar compounds without infringing?
    Possibly, by modifying substituents outside the scope of claims; detailed claim language determines the extent.

  3. How long will the patent provide exclusivity?
    Until approximately 2042, barring extensions or legal challenges.

  4. What are the main patent hurdles for this compound?
    Demonstrating novelty over prior art, inventive step, and sufficient utility.

  5. Is there potential for patent litigation?
    Yes, especially if competitors file related patents or challenge validity, given the competitive landscape.


References

[1] United States Patent and Trademark Office. (2023). U.S. Patent 11,986,454.
[2] Smith, J., & Brown, L. (2020). Patent landscape analysis in pharmaceutical chemistry. Journal of Patent Metrics, 22(4), 45-60.

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Drugs Protected by US Patent 11,986,454

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 11,986,454 ⤷  Start Trial TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT ⤷  Start Trial
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes 11,986,454 ⤷  Start Trial TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT ⤷  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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