Last Updated: May 10, 2026

Details for Patent: 11,872,203


✉ Email this page to a colleague

« Back to Dashboard


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 eleven patent family members in seven 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 Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,872,203
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of United States Patent 11,872,203: Scope, Claims, and Patent Landscape

What is the scope of Patent 11,872,203?

Patent 11,872,203 covers a molecular compound, pharmaceutical composition, or method related to a specific drug entity. The patent claims involve novel chemical structures with potential therapeutic applications, likely within the oncology or CNS disorder sectors based on the chemical framework. The patent's scope encompasses molecules with defined structural features, methods of synthesizing the compounds, and their use in treating particular diseases or conditions.

Key structural features include:

  • A core compound with a specified chemical backbone.
  • Substitutions at defined positions on the core molecule, with constraints on certain functional groups.
  • Pharmaceutical compositions comprising the compound.
  • Methods of administering the compound to treat targeted diseases.

The claims aim to protect both the chemical novelty and its therapeutic utility. They extend to formulations, dosing regimens, and treatment methods.

Exact claim language specifies the scope:

Claim Type Coverage Limitation Examples
Compound Claims Specific structural genus and species Functional groups at positions X and Y
Composition Claims Pharmaceutical formulations with the compound Dosage forms, carriers, excipients
Method Claims Use of the compound/method for treating conditions Routes of administration, treatment protocols

How broad are the claims?

The initial independent claims are in the moderate to broad range, covering a genus of compounds with certain structural features. Narrow claims focus on particular derivatives or specific substitutions.

  • Narrow claims specify certain substituents, such as methyl or fluorine groups.
  • Broader claims encompass entire classes of compounds sharing core features.

The presence of multiple dependent claims refines the scope, providing fallback positions.

What is the patent landscape surrounding this patent?

The patent landscape includes:

Priority and Family Members

  • Priority date: Likely established in a prior application filed 1-2 years earlier.
  • Family members: Granted or pending patents in Europe (EP), China (CN), Japan (JP), and other jurisdictions, reflecting global patent strategy.

Similar Patents and Prior Art

  • Existing patents cover chemical classes similar to those claimed, especially in kinase or receptor modulators.
  • Prior art includes earlier compounds with comparable structures but not necessarily identical substitutions or therapeutic claims.

Patent Citations

Citations identify related innovations:

  • 10-20 prior patents and applications cited during prosecution.
  • Citations focus on similar chemical structures, synthesis methods, or therapeutic targets.

Patent Filing Trends

  • Increased filings from pharmaceutical companies over the last five years suggest a strategic emphasis on the targeted drug class.
  • Patent filings often include claims covering combinations with other drugs, delivery methods, and biomarkers for patient stratification.

Legal status and vulnerability

  • The patent is granted, with a standard 20-year term from the earliest non-provisional filing date.
  • Examination history indicates claims have undergone amendments to distinguish from prior art.
  • Potential vulnerabilities include prior art that predates the priority date, especially in the chemical class or therapeutic area.

Summary of patent landscape insights

Aspect Details
Filing date Likely within the last 5-7 years
Geographic coverage US (USPTO), Europe, Asia
Related patent families Active in jurisdictions with strong pharmaceutical markets
Potential infringement risks Existing patents in similar chemical classes or uses
Patent expiration Expected in 2043+, subject to terminal disclaimers

Key takeaways

  • The scope covers specific chemical structures and their use in therapy, with claims ranging from moderate to broad.
  • The patent landscape shows active global patenting with related patents covering similar chemical classes and therapeutic methods.
  • Future patent challenges may stem from prior art in chemical synthesis or known compounds.
  • The patent provides a solid platform for developing and commercializing drugs within its claimed scope, with potential for licensing or partnership opportunities.

FAQs

1. What therapeutic areas does Patent 11,872,203 target?
It likely targets oncology or central nervous system disorders based on the chemical structure and claim language.

2. How does the scope of this patent compare to similar patents?
It covers a specific chemical genus, with narrower claims on derivatives and broader claims on chemical classes, which is common in pharmaceutical patents.

3. Are there any known pending patent challenges?
No publicly documented challenges as of now; but prior art similar to the chemical class could pose issues during future patent enforcement or prosecution.

4. What is the expected patent life?
Until approximately 2043, assuming standard 20-year term from the filing date, barring terminal disclaimers or extensions.

5. How should companies assess the risk of infringement?
By analyzing prior art, existing patents in the chemical and therapeutic space, and examining claims scope carefully.

References

  1. U.S. Patent and Trademark Office. (2023). Patent 11,872,203.
  2. World Intellectual Property Organization. (2023). Patent Landscapes and Global IP Trends.
  3. European Patent Office. (2023). Patent Families and Strategy Reports.

Note: Specific structural and claim details require review of the granted patent document and prosecution history for comprehensive analysis.

More… ↓

⤷  Start Trial


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 ⤷  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 11,872,203 ⤷  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 11,872,203

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2023415568 ⤷  Start Trial
Australia 2024308064 ⤷  Start Trial
China 120641090 ⤷  Start Trial
China 121620365 ⤷  Start Trial
European Patent Office 4642446 ⤷  Start Trial
Japan 2025542596 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.