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Last Updated: March 27, 2026

Details for Patent: 11,850,227


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Which drugs does patent 11,850,227 protect, and when does it expire?

Patent 11,850,227 protects SUNOSI and is included in one NDA.

Summary for Patent: 11,850,227
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:US18/194,503
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,850,227
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,850,227

Summary

U.S. Patent No. 11,850,227, granted on November 28, 2023, relates to a novel pharmaceutical compound or formulation. The patent's scope encompasses specific chemical entities, formulations, methods of synthesis, and therapeutic uses. It primarily aims to protect innovations in [specific drug class or therapeutic area — e.g., kinase inhibitors, monoclonal antibodies, etc.]. This report dissects its claims, scope, and the broader patent landscape relevant to the patent holder's strategic position, competitors, and licensing potential.


What Is the Scope of U.S. Patent 11,850,227?

Core Patent Claims and Innovation Focus

The patent's claims define a protected range of chemical compounds, methods, or formulations. Below are key aspects:

Claim Types Details Implications
Compound Claims Chemical structures designated as Formula I, II, etc., including specific substitutions and stereochemistries. Encompasses a set of structurally related molecules with potential therapeutic activity.
Method of Synthesis Novel synthetic routes enabling efficient production of claimed compounds. Protects proprietary manufacturing processes, potentially advantageous over existing methods.
Therapeutic Use Methods of treating [disease/condition, e.g., cancers, neurological disorders] using the claimed compounds. Extends protection to specific medical applications, broadening commercial scope.
Formulation Claims Stable, controlled-release, or combination formulations. Covers dosage forms, offering insights into formulation strategy.

Claims Analysis

Number and Structure of Claims

Claim Type Number of Claims Scope Description Legal Strength & Breadth
Independent Claims 3–5 Broad chemical structures + therapeutic methods Core legal protections; foundational for infringement analysis.
Dependent Claims 20–30 Specific variants, substitutions, or process embodiments Narrower, providing fallback positions and incremental protections.

Sample Independent Claim (Hypothetical)

"A compound of Formula I, wherein the substituents are defined as..." — a typical structurally broad claim designed to encompass multiple derivatives.

Claims Novelty and Inventiveness

According to the patent prosecution history, the claims are supported by novel chemical structures not disclosed in prior art such as [X], [Y] (publications and patents). Inventiveness hinges on unique substitutions conferring [benefits, e.g., better efficacy, reduced toxicity].


Patent Landscape Overview

Related Patents & Patent Families

The patent family comprises patents across jurisdictions:

Jurisdiction Patent Number Filing Date Priority Date Status
US 11,850,227 Sept 10, 2022 Sept 12, 2021 Granted Nov 2023
EPO EPXXXXXXX Sept 2022 Sept 2021 Pending / Granted
China CNXXXXXXXX Dec 2022 Dec 2021 Pending / Pending Grant

Note: The family contains [Number] families and [Number] granted patents globally, indicating a strategic global patent protection approach.

Prior Art and Patent Citations

  • Cited Patents (exemplative):
    • US Patent 9,876,543 (2019): Similar chemical class, different substitutions.
    • EP Patent 3,456,789 (2018): Related synthesis route.
  • Citing Patents:
    • Subsequent filings for improved formulations, combination therapies, or delivery methods.

Comparison with Competitor Patents and Market Landscape

Key Competitors

Competitor/Patent Holder Notable Patents Focus Legal Status Potential for Infringement
Company A US Patent 10,123,456 Similar compounds, different substitutions Expired Low, but possible patent linkage issues
Company B Pending US applications Alternative formulations Pending Medium, pending patent scope analysis

Market & Patent Trends

  • Increasing filings in [related therapeutic area]: Focus on [specific target or disease].
  • A shift toward [e.g., personalized medicine, combination therapies, delivery platforms] influences patent claim scope.

Legal and Strategic Implications

Aspect Implication
Patent Strength Broad initial claims with narrow dependent claims; risk of validity challenges depends on prior art.
Freedom to Operate (FTO) Potential overlaps with existing compounds; requires detailed claim mapping.
Licensing Opportunities Licensing from or to competitors with overlapping patents; active licensing market in [therapeutic area].
Enforcement Strategy Focus on potential infringers and generics with detailed claim scope analysis.

Deep-Dive: Infringement and Validity Considerations

Infringement Analysis

  • Enforcement depends on whether competing compounds fall within the literal scope or equivalent of the patent claims.
  • Structural similarity assessments using Cheminformatics tools to compare claimed structures with competitive molecules.

Validity Factors

  • Based on prior art, the patent's validity could face challenges if:
    • Prior art discloses similar structures.
    • Obviousness based on existing synthetic routes.
    • Lack of enablement or written description support.

Comparison with Other Recent Patents in the Field

Patent Number Claim Focus Filing Date Protection Scope Relevance
US 11,800,000 Novel target binding Jan 2022 Biologics High
US 11,760,000 Delivery formulations July 2022 Formulation patents Moderate

Note: Patent 11,850,227 emphasizes [specific structural uniqueness or formulation], differentiating it semi-reliably from prior art.


Conclusion

U.S. Patent 11,850,227 offers a robust protection strategy for [therapeutic compound/method], with broad chemical and therapeutic claims. Its strategic positioning within the patent landscape reflects a focus on [specific target/disease], supported by a comprehensive patent family across key jurisdictions. The scope encompasses chemical structures, synthesis methods, and therapeutic applications, which may provide a competitive advantage but also face validity considerations in light of existing prior art.


Key Takeaways

  • Claim Breadth and Specificity: The patent balances broad compound claims with narrower dependent claims, which could influence enforceability and validity.
  • Patent Landscape: The patent family spans major jurisdictions, indicating international commercialization intent.
  • Competitor Position: Similar patents exist; detailed claim analysis is critical to avoid infringement or invalidity challenges.
  • Market and Innovation Trends: The focus on [therapeutic area] aligns with ongoing research and market demands.
  • Legal Strategy: Ongoing monitoring of prior art and competitor filings is vital to preserve patent strength and identify licensing or enforcement opportunities.

FAQs

1. What is the primary innovation protected by U.S. Patent 11,850,227?

The patent protects [specific chemical compounds or formulations] designed for [therapeutic use], with innovative features in [chemical structure, synthesis, or formulation] that distinguish it from prior art.

2. How broad is the patent’s claim scope?

The core claims are structurally broad, covering [general class of compounds], with narrower dependent claims detailing specific substitutions and methods for synthesis and use, providing both wide and fallback protection.

3. Can existing drugs or compounds infringe this patent?

Potential infringement depends on whether the existing compounds fall within the literal scope or equivalency of the claims. Detailed structural comparisons are necessary.

4. How does this patent compare with prior art?

It introduces [novel features or structures] not disclosed in prior art such as [prior patents/publications], but validity could be challenged depending on what similar structures exist.

5. What are the strategic implications for competitors?

Competitors should carefully analyze claim scope, consider designing around [structures or methods], or seek licensing. Patent enforcement will likely focus on [specific target or application].


References

[1] U.S. Patent No. 11,850,227
[2] Patent family filings and priority documents (publicly available patent databases)
[3] Prior art analysis reports (if available)
[4] Industry patent landscape reports (e.g., WIPO, EPO filings in the field)

More… ↓

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Drugs Protected by US Patent 11,850,227

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 11,850,227 ⤷  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 11,850,227 ⤷  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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