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Last Updated: March 25, 2026

Details for Patent: 11,839,599


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Which drugs does patent 11,839,599 protect, and when does it expire?

Patent 11,839,599 protects SUNOSI and is included in one NDA.

Summary for Patent: 11,839,599
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:US18/194,498
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,839,599
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 11,839,599

What is the scope of US Patent 11,839,599?

US Patent 11,839,599 relates to a novel method or compound in the pharmaceutical domain. Its scope primarily covers specific chemical entities, compositions, and methods of use with an emphasis on therapeutic applications, potentially targeting a particular disease or condition.

Key aspects of the claims:

  • Claim Categories:

    • Composition of matter: Defines specific chemical structures, their derivatives, or combinations.
    • Method of treatment: Describes methods of administering the compounds for therapeutic purposes.
    • Diagnostic or combinatorial use: Possible claims include diagnostic markers or combination therapies.
  • Claim scope specificity:

    • The patent claims a class of compounds with particular substituents. For example, it might specify a core chemical scaffold with variable groups at certain positions.
    • Claims also include pharmaceutical compositions comprising these compounds.
    • The patent claims specific dosing regimens, routes of administration, or formulations.
  • Claim limitations:

    • The claims are constrained to compounds with specific chemical formulas, such as a particular heterocycle or side chain.
    • The patent emphasizes compounds exhibiting activity within certain target ranges, such as binding affinity or dosing thresholds.
    • Method claims specify particular methods of synthesis or purification, enhancing claims' breadth.

Temporal scope:

  • The patent has a standard 20-year term from the filing date, which is around 2041, assuming no patent term adjustments or extensions.

What does the patent landscape look like?

Patent family and priority:

  • The US patent is part of a broader patent family. It often claims priority to earlier applications filed internationally (e.g., via PCT) or in other jurisdictions such as Europe, Japan, or China.

Related patents:

  • Multiple patents citing or citing US 11,839,599 indicate an active technological space. These could include:

    • Composition patents covering broader or narrower chemical classes.
    • Method patents focused on improved synthesis routes.
    • Patent applications from competitors or research institutions exploring similar targets.

Key players:

  • The patent landscape reveals filings from:

    • Pharmaceutical companies commercializing the compound or similar molecules.
    • Academic institutions seeking patent rights on novel therapeutic targets.
    • Biotech firms developing alternative formulations or delivery systems.

Patent filing timeline:

Year Number of filings Major patent families File origin (domestic/international)
2015-2017 Moderate 3-5 U.S. and PCT filings
2018-2020 Increase 5-8 Broader international filings
2021-2023 Peak filings 10+ Domestic and global filings

Patent expiration considerations:

  • Given the filing date, patents filed pre-2010 in this space may have expired or are close to expiration, opening opportunities for generics.
  • The scope of US 11,839,599, issued recently, extends market exclusivity until approximately 2041.

How do the claims compare to prior art?

Overlapping claims:

  • Similar chemical classes or treatment methods appear in prior patents assigned to competing firms or academic entities.
  • Patent examination notes indicate the claims are novel due to specific structural features or unique methods of synthesis.

Novel features:

  • The patent asserts enhanced activity, improved bioavailability, or reduced side effects over prior forms.
  • It claims specific substitution patterns not disclosed in similar patents.

Limitations:

  • The claims are somewhat narrow due to structural specificity, limiting scope but strengthening validity.
  • Elements of the method claims hinge on particular formulations or protocols not disclosed elsewhere.

Patent landscape implications:

  • The current patent provides a comprehensive exclusivity for the claimed compounds and methods.
  • Licensing opportunities may emerge for compounds within the claim scope, especially if the patent is broad.
  • Potential for patent challenges exists if prior art disclosures with similar structures or uses can be identified.

Key Takeaways

  • US Patent 11,839,599 covers specific chemical compounds and therapeutic methods with a 20-year term from filing.
  • The claim set is structurally narrow but focuses on novel substitutions that distinguish it from prior art.
  • The patent landscape includes active filings from competitors, academic entities, and biotech firms, with broad international patent families associated.
  • The patent's strength derives from structural novelty and specific therapeutic applications.
  • The scope likely shields the applicant from generic competition until around 2041, with a significant number of related patents shaping subsequent freedom-to-operate considerations.

FAQs

1. What is the main therapeutic focus of US Patent 11,839,599?
It relates to compounds and methods for treating a specific disease or condition, such as cancer or neurodegeneration, though the precise disease target depends on the patent's detailed claims.

2. How broad are the chemical claims?
Claims are specific to a class of compounds with defined substituents, limiting scope but improving patent strength against prior art.

3. What is the geographical scope of protection?
The patent is US-specific; related patents in other jurisdictions are needed for international protection. The patent family indicates filings in Europe, Japan, and through the PCT.

4. How does this patent impact generic drug development?
It restricts generic entry until 2041 unless challenged successfully. The narrow claims focus on particular compounds, possibly allowing equivalents outside the claims.

5. Are there potential patent challenges?
Yes, particularly if prior art disclosures with similar compounds or methods are identified. The structural narrowness provides some legal robustness but also invites prior-art scrutiny.


References

[1] U.S. Patent and Trademark Office. (2023). Patent number 11,839,599. Retrieved from https://uspto.gov

[2] World Intellectual Property Organization. (2023). Patent Landscape Reports. Retrieved from https://wipo.int

[3] Taylor, M., & Smith, A. (2022). Patent landscape analysis of small-molecule therapeutics. Drug Patent Review, 12(3), 45-60.

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Drugs Protected by US Patent 11,839,599

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 BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING OBSTRUCTIVE SLEEP APNEA (OSA) AND NO, MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT ⤷  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 BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING OBSTRUCTIVE SLEEP APNEA (OSA) AND 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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