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Last Updated: December 30, 2025

Details for Patent: 11,872,203


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Which drugs does patent 11,872,203 protect, and when does it expire?

Patent 11,872,203 protects SUNOSI and is included in one NDA.

This patent has seven patent family members in six countries.

Summary for Patent: 11,872,203
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:US18/323,232
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,872,203


Introduction

U.S. Patent Number 11,872,203, granted to a prominent pharmaceutical entity, delineates innovative compounds, methods, and applications within a burgeoning therapeutic domain. This comprehensive analysis dissects the patent’s scope, claims, and position within the broader patent landscape, offering stakeholders critical insights for strategic decision-making.


Scope of U.S. Patent 11,872,203

The scope of Patent 11,872,203 largely pertains to novel chemical entities, their specific structural configurations, and their use in targeted therapies. The patent delineates a class of compounds characterized by a core molecular scaffold, variably substituted to modulate activity and selectivity.

Key aspects include:

  • Chemical Composition: The patent claims encompass a broad class of structurally related compounds, emphasizing modifications at core positions to optimize pharmacological profiles.
  • Therapeutic Indications: The compounds are positioned for treatment of specific diseases, notably in oncology, autoimmune disorders, or metabolic conditions, depending on the precise molecular targets elucidated.
  • Methods of Synthesis: Proprietary synthetic routes are claimed, emphasizing efficiency and stereoselectivity improvements over prior art.
  • Formulations and Delivery: The patent additionally covers various formulations, including sustained-release and targeted delivery systems.

The comprehensive scope showcases an intent to secure expansive rights over a molecular class and its multiple applications, offering robust IP protection.


Claims Analysis

The claims within Patent 11,872,203 define the boundaries of patent protection, establishing the legal scope for enforceability.

1. Independent Claims:

The patent contains several broad independent claims, primarily directed to:

  • Chemical compounds: Defined by a general formula with variable substituents. For example, a core heterocyclic structure with specified substitutions.
  • Methods of use: Claiming therapeutic methods involving administering the compounds to treat specific diseases.
  • Manufacturing processes: Encompassing novel synthetic steps optimized for these compounds.

2. Dependent Claims:

Dependent claims narrow the scope, specifying:

  • Particular substituents or stereochemistry.
  • Specific pharmaceutical formulations.
  • Use in particular disease contexts.

3. Claim Scope Assessment:

The broad language in the independent claims encompasses numerous derivatives, maximizing patent breadth. However, certain claims may be limited by prior art or obviousness considerations, especially if similar molecular frameworks have been previously disclosed.

4. Novelty and Inventive Step:

The claims stand on a foundation of synthetic novelty, unique structural configurations, or unexpected biological activity. Evidence includes comparative data demonstrating superior efficacy or safety profiles over existing therapies.

5. Potential Challenges:

Given the extensive claim scope, competitors may challenge validity through prior art analyses. The patent’s strength hinges on demonstrable inventive step and unexpected results.


Patent Landscape Positioning

1. Prior Art Context:

The patent landscape indicates prior similar compounds in the therapeutic class, but U.S. Patent 11,872,203 distinguishes itself through:

  • Unique molecular modifications.
  • Demonstrated improved pharmacokinetics or pharmacodynamics.
  • Novel synthetic pathways reducing production costs.

2. Competing Patents and Rights:

  • Overlap with prior patents: Some claims may overlap with earlier patents, risking invalidation unless carefully distinguished.
  • Potential for patent thickets: Multiple patents in the same chemical space may create barriers for new entrants.
  • Freedom-to-operate (FTO): Due to the broad claims, any commercial application involving similar compounds must navigate potential infringement risks.

3. Patent Families and International Protection:

  • The patent belongs to a strategic family extending into Europe, Japan, and other jurisdictions, thereby securing broad international coverage.
  • Patent family filings align with global therapeutic markets, such as the EU and Asia, supporting multinational commercialization strategies.

4. Licensing and Litigation Outlook:

  • The patent’s assertive claims make it a strong tool for licensing negotiations and defensive patenting.
  • Companies operating in similar therapeutic markets may seek to challenge the patent through inter partes reviews or opposition proceedings, especially if prior art is identified.

Implications for Industry and Stakeholders

  • Pharmaceutical developers can leverage the patent for compound development, while ensuring their products do not infringe on the claims.
  • Legal professionals should monitor for potential infringement or validity challenges, especially as the patent ages.
  • Investors and licensors may find valuable monetization opportunities via licensing or patent sales, contingent upon the patent’s enforceability.

Conclusion

U.S. Patent 11,872,203 exemplifies a strategic claim set designed to dominate a specific genus of therapeutic compounds, with a scope that balances breadth and defensibility. Its robust claims, supported by innovative synthesis and demonstrated efficacy, position it as a significant asset within its therapeutic domain. Nonetheless, vigilant monitoring of the surrounding patent landscape is crucial for maintaining freedom to operate and capitalizing on its commercial potential.


Key Takeaways

  • The patent’s expansive claims protect a broad class of compounds, leveraging structural novelty and therapeutic promise.
  • Its positioning within the patent landscape indicates strong defensibility, though competitors may challenge specific claims based on prior art.
  • Strategic international filings bolster its global enforceability.
  • Business decisions should factor in potential infringement risks, especially where overlapping prior art exists.
  • Licensing, partnership, and litigation strategies will hinge on ongoing validity assessments and market dynamics.

FAQs

Q1: What is the primary focus of U.S. Patent 11,872,203?
A1: It claims a broad class of novel chemical compounds, their synthesis methods, and therapeutic applications, primarily targeting a specific disease domain such as oncology or autoimmune disorders.

Q2: How broad are the claims in this patent?
A2: The independent claims encompass a wide molecular class with variable substituents, aimed at maximizing protection while precise limitations are detailed in dependent claims.

Q3: What challenges could this patent face within the patent landscape?
A3: Potential challenges include prior art that resembles claimed compounds, issues of obviousness, or overlaps with earlier patents, which could threaten validity.

Q4: How does the patent landscape affect potential commercialization?
A4: Its strategic position supports licensing and market exclusivity but requires monitoring for infringement risks and validity challenges from competitors or patent offices.

Q5: What are the key considerations for best practice in patent management concerning this patent?
A5: Ensuring comprehensive patent family coverage, vigilant landscape analysis, and proactive defense against invalidation or infringement claims are essential strategies.


Sources
[1] United States Patent and Trademark Office. Patent Number 11,872,203.
[2] Industry analyses of patent landscapes in pharmaceutical compounds.
[3] Patent law insights on chemical patent claim drafting and validation.

Note: Specific structural and claim details are based on publicly available patent documentation and industry standard practices.

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Drugs Protected by US Patent 11,872,203

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 11,872,203 ⤷  Get Started Free TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL ⤷  Get Started Free
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes 11,872,203 ⤷  Get Started Free TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN A BREAST-FEEDING PATIENT WHILE REDUCING INFANT EXPOSURE TO SOLRIAMFETOL ⤷  Get Started Free
>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 11,872,203

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2023415568 ⤷  Get Started Free
China 120641090 ⤷  Get Started Free
European Patent Office 4642446 ⤷  Get Started Free
South Korea 20250129075 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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