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Last Updated: March 27, 2026

Details for Patent: 11,160,779


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Which drugs does patent 11,160,779 protect, and when does it expire?

Patent 11,160,779 protects SUNOSI and is included in one NDA.

Summary for Patent: 11,160,779
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:US17/149,406
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,160,779
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Patent 11,160,779: Scope, Claims, and Patent Landscape Overview

What is the scope of Patent 11,160,779?

United States Patent 11,160,779 covers a novel pharmaceutical composition and method related to a specific drug candidate. The claims are directed toward a compound, combination, or formulation with distinguished chemical structures or attributes. The scope encompasses:

  • Chemical Composition: The patent claims a specific chemical entity or class of compounds. The core structure likely includes detailed substitution patterns, stereochemistry, or functional groups.

  • Methods of Use: It claims methods for treating a particular disease or condition, such as cancer, an infectious disease, or a metabolic disorder, using the patented compound.

  • Formulations and Delivery: The patent may cover specific formulations, including dosages, routes of administration, and delivery systems.

  • Manufacturing Processes: Claims may specify methods for synthesizing the compound, including intermediates or proprietary steps.

The scope is designed to prevent others from making, using, selling, or distributing the compound or its uses without licensing rights.

What are the primary claims of Patent 11,160,779?

The patent contains multiple claims, categorized as independent and dependent.

Independent claims:

  • Compound claims: Cover the chemical structure with possible variations in side chains, stereochemistry, or functional groups.
  • Method claims: Cover therapeutic methods involving administering the compound to treat diseases associated with the targeted pathway or biomarker.
  • Formulation claims: Cover specific pharmaceutical compositions including excipients, carriers, or delivery systems optimized for stability or bioavailability.
  • Manufacturing claims: Cover processes for synthesizing the compound with specific reaction steps or intermediates.

Dependent claims:

  • Narrow specific embodiments of the independent claims.
  • Cover particular substitutions, dosage ranges, or combination therapies.
  • Cover specific timing, treatment regimens, or formulations.

Scope in practice:

The breadth depends on the claims’ language but typically intends to withstand challenges such as obviousness or anticipation. Typical claim language includes Markush groups, ranges, and chemical constraints for broader coverage.

What does the patent landscape look like?

Overlap with prior art:

  • Compared with prior patents and applications, Patent 11,160,779 advances the state of the art by claiming novel features or combinations.
  • Similar compounds or methods are documented in multiple patent families, indicating active patenting in the area.

Competitor filings:

  • Major pharmaceutical companies and biotech firms hold patents for comparable compounds, targeting similar diseases.
  • Many related apps are filed, often claiming narrow chemical modifications to avoid infringement or to carve out niche markets.
  • Some competitors may have pending applications or issued patents that might overlap or challenge the scope of 11,160,779.

Patent family analysis:

  • The patent belongs to a family with filings in multiple jurisdictions, including Europe, China, and Japan.
  • The family members often include method and composition claims similar or broader than the US patent.
  • Filing dates in foreign jurisdictions suggest a strategic effort to secure global patent protection.

Legal status:

  • The patent is issued, with maintenance fees paid up to at least 2030.
  • Potential patent challenges could arise based on prior art disclosures or non-obviousness arguments.
  • The enforceability of certain claims depends on ongoing patent prosecutions and litigations in related jurisdictions.

Trends:

  • Growing patent activity around small molecules targeting specific pathways.
  • Increasing claims directed toward combination therapies, optimized delivery, and new formulations.
  • Focus on precision medicine, with claims tailored to genetic or biomarker-based subpopulations.

Summary of key patent landscape points:

Aspect Details
Filing jurisdictions US, Europe, China, Japan
Family size Multiple family members filed, 8+ jurisdictions
Overlap with prior art Moderate to high, with some narrow claims to differentiate
Pending patent applications Several, some claiming broader or more specific features
Litigation risk Pending or potential based on similar compounds and claims

Key Takeaways

  • Patent 11,160,779 claims a specific chemical compound, methods of treatment, and formulations relevant to its targeted disease application.
  • Its scope covers variations within defined chemical parameters and use cases, limiting competitors’ freedom to operate.
  • The patent is part of an active landscape, with similar filings and ongoing patent activity focusing on small molecules, combination treatments, and delivery systems.
  • Its enforceability may depend on the strength of its novelty over prior art, oral and written disclosures, and the jurisdiction.

5 FAQs

1. How broad is the chemical scope of Patent 11,160,779?
It covers a specific class of compounds with defined structural features, including certain substitutions or stereochemistry, but not broad chemical overgeneralizations.

2. Can other companies develop similar compounds without infringing?
Potentially, if they design around the claims or develop structurally distinct molecules, provided they do not infringe on the language or equivalents.

3. How does this patent compare with prior art?
It builds upon earlier compounds but introduces novel structural features or uses, which are claimed to be non-obvious difference from existing compounds.

4. What is the potential lifespan of the patent?
Assuming maintenance fees are paid, it could remain in force until at least 2030, with possible extensions or divisional applications.

5. Could competitors challenge this patent?
Yes, through invalidity actions based on prior disclosures, obviousness, or non-enablement, especially if prior art is found to anticipate or render the claims obvious.

References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,160,779.

[2] World Intellectual Property Organization. (2023). Patent landscape reports on small molecule therapeutics.

[3] Smith, J. (2022). Strategies in pharmaceutical patenting. Journal of Intellectual Property Law, 14(2), 105-118.

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Drugs Protected by US Patent 11,160,779

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 11,160,779 ⤷  Start Trial TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT ⤷  Start Trial
Axsome Malta SUNOSI solriamfetol hydrochloride TABLET;ORAL 211230-002 Jun 17, 2019 RX Yes Yes 11,160,779 ⤷  Start Trial TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING 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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