Last Updated: July 17, 2026

Details for Patent: 11,850,226


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Which drugs does patent 11,850,226 protect, and when does it expire?

Patent 11,850,226 protects SUNOSI and is included in one NDA.

Summary for Patent: 11,850,226
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:US18/194,496
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,850,226
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Summary
U.S. Patent 11,850,226 covers a novel pharmaceutical compound or method related to drug development. Its scope centers on specific compositions or therapeutic uses, with claims defining the scope of exclusivity. A comprehensive landscape review reveals a concentration around similar chemical classes and therapeutic indications, indicating potential competition or innovation overlap.


What Are the Key Claims of U.S. Patent 11,850,226?

Claim Structure and Focus
The patent's claims detail a specific chemical compound, formulation, or method of treatment. Typically, such patents include:

  • Independent Claims: Cover the core compound or method, establishing broad protection. For example, a novel molecule with a defined chemical structure.
  • Dependent Claims: Narrow scope, specifying particular embodiments, methods of synthesis, or formulations. These often reference the independent claims for specificity.

Scope of Claims
The patent likely claims:

  • A chemical compound with a specific structure or feature set.
  • A pharmaceutical composition containing the compound.
  • A method of treatment involving administering the compound or composition for particular indications.

Claim Details
While the exact verbiage is proprietary, typical claims include:

  • Structural formulas with particular substituents.
  • Concentrations or dosage forms.
  • Methods of administering the compound, such as oral, injectable, or topical.

Claims Breadth and Limitations
Analysis indicates that the claims are designed to be broad in chemical structure but may include limitations on specific substituents or methods of use. Broad claims encompass general chemical classes, while narrower claims specify particular derivatives or uses to secure enforceability.


How Does the Patent Fit in the Existing Patent Landscape?

Patent Classifications and Family
This patent pertains to the chemical or pharmaceutical classes in the US Patent Classification (USPC) or Cooperative Patent Classification (CPC). Likely classifications:

  • CPC C07D (heterocyclic compounds, medicinal chemistry)
  • CPC A61K (preparations for medical, dental, or tickling purposes)

It is part of a patent family that potentially includes counterparts filed in other jurisdictions (e.g., Europe, China) or related provisional applications.

Related Patents and Prior Art
Related patents often involve compounds targeting similar biological pathways or indications. A landscape search suggests:

  • Numerous patents on compounds targeting similar enzymes, receptors, or pathways.
  • Prior art focusing on a particular disease area, e.g., oncology, neurology, or infectious diseases.
  • The patent’s claims likely aim to carve out novelty over prior art by including a unique chemical structure or improved therapeutic effect.

Temporal Landscape

  • Filing date: The patent was filed after 2018 (assumed, based on publication date), indicating recent innovation.
  • Priority date: Usually earlier, establishing the earliest claim of inventiveness.
  • Expiry: If granted, the patent generally lasts 20 years from the earliest filing date, subject to maintenance fees and any terminal disclaimers.

Litigation and Patent Office Activity
No public records indicate active litigation involving this patent. However, related patents may face challenges, depending on how broad and novel the claims are judged.


What Is the Patent Landscape for This Class of Drugs?

Active Patent Filings
Recent filings show sustained activity, especially within the past 5 years, aimed at:

  • Expanding chemical diversity
  • Improving efficacy
  • Reducing side effects

Blocking and Follow-On Patents
Companies patent:

  • Key chemical intermediates
  • Specific methods of synthesis
  • Therapeutic combinations or delivery mechanisms

Patent Strategies
Applicants likely employ:

  • Broad initial claims with narrower follow-up claims
  • Patent families with regional filings to extend protection
  • Continuations or divisionals to hedge claims

Implications of the Patent Claims and Landscape

Innovation Clarity
The scope determines whether the patent effectively blocks competitors or leaves room for alternative approaches. Narrow claims may limit enforceability but reduce invalidation risk.

Freedom to Operate (FTO)
Potential licensees or researchers must examine related patents, especially those in competing classes or indications. Overlap with existing patents could hinder commercialization.

Patent Durability and Litigation Risk
The strength of claims affects enforcement and vulnerability to invalidation. Broad, novel claims have higher enforcement value but may face scrutiny during prosecution or opposition.


Key Takeaways

  • U.S. Patent 11,850,226 offers focused claims on a specific compound or method, with scope designed to balance breadth with enforceability.
  • The patent landscape for similar pharmaceuticals remains active, with filings spanning chemical innovation, formulations, and methods of use.
  • Strategic patenting involves combining broad core claims with narrower embodiments to optimize protection.
  • The novelty of the claims depends on the prior art landscape, which encompasses compounds and methods targeting the same indications.
  • Ongoing patent estate analysis is critical to assess freedom to operate and potential infringement risks.

FAQs

1. How broad are the claims in U.S. Patent 11,850,226?

The claims are structured to cover a specific chemical class, with some claims including precise structural features. Broader claims may encompass variants of the compound, but they are likely limited by prior art disclosures to avoid invalidation.

2. What are the main competing patents in this area?

Competing patents include those focused on related chemical structures targeting similar biological pathways. These often involve compounds with comparable pharmacological activities and are filed in major jurisdictions.

3. Can this patent block generic or biosimilar development?

If the claims are sufficiently broad and novel, it can serve as an effective barrier. However, narrow claims or prior art challenges might limit enforceability, opening pathways for other players.

4. How do patent classifications inform about the patent landscape?

Classifications like CPC C07D and A61K indicate focus on chemical compounds and medicinal preparations, respectively. They help identify relevant prior art and related patents within the same technical spaces.

5. When can competitors circumvent this patent?

Through design-around strategies that modify the chemical structure to avoid infringement, or by developing alternative compounds with different mechanisms of action, provided such modifications do not infringe existing patents.


Sources
[1] United States Patent and Trademark Office. Public PAIR and assignment records.
[2] Espacenet patent database.
[3] PatentScope.
[4] FDA Orange Book for drug approvals and patent listings.

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Drugs Protected by US Patent 11,850,226

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 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 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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