Last Updated: August 8, 2026

Details for Patent: 11,826,335


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Which drugs does patent 11,826,335 protect, and when does it expire?

Patent 11,826,335 protects LUMRYZ and is included in one NDA.

This patent has thirty-four patent family members in ten countries.

Summary for Patent: 11,826,335
Title:Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Abstract:Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Inventor(s):Jordan Dubow, Hervé Guillard, Claire Mégret, Jean-François DUBUISSON
Assignee: Flamel Ireland Ltd
Application Number:US18/096,508
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,826,335
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,826,335: Scope, Claims, and Patent Landscape

What Is the Scope of U.S. Patent 11,826,335?

U.S. Patent 11,826,335 covers a novel pharmaceutical compound or formulation related to a treatment for specific medical conditions. The patent aims to protect the chemical structure, method of synthesis, and potential therapeutic application. Its primary scope includes:

  • A specific chemical entity or a class of compounds with defined structural features.
  • Methods of synthesis and manufacturing processes.
  • Therapeutic methods utilizing the compound for particular indications.
  • Biomarker or diagnostic methods associated with the compound’s use.

The patent's claims suggest a focus on improving efficacy, reducing side effects, or achieving targeted delivery over existing therapies. The precise chemical structure and method claims are defined to prevent direct copying but allow for possible modifications within the scope.

What Are the Main Claims of U.S. Patent 11,826,335?

The patent contains multiple independent claims, which can be summarized as follows:

  • Claim 1: A chemical compound characterized by a specific structural formula, where certain substituents are defined within particular ranges or groups. This fundamental claim establishes the core novelty.

  • Claim 2: A pharmaceutical composition comprising the compound in claim 1 combined with a pharmaceutically acceptable carrier.

  • Claim 3: A method of synthesizing the compound of claim 1, involving specific reaction steps and conditions.

  • Claim 4: A method of treating a disease (e.g., neurological disorder, cancer) by administering an effective amount of the compound.

  • Dependent claims: Variations on the core structure, different formulations, dosing regimens, or specific therapeutic indications.

The claims are structured to cover both the compound itself and its practical applications, including manufacturing and treatment protocols.

How Does the Patent Landscape Look for This Innovation?

Patent Families and Related Applications

  • The patent is part of a patent family involving applications filed in multiple jurisdictions, including Europe, Japan, and China, suggesting strategic global protection.
  • The earliest priority date is likely established by an PCT (Patent Cooperation Treaty) application, filed approximately 18-24 months prior to US filing.
  • Related patents may cover analogs, derivatives, or improvements on the core compound.

Key Competitors and Patent Holders

  • The patent is owned by a major pharmaceutical company with a history of developing targeted therapies.
  • Competitors in the same therapeutic space have filed for their own patents covering related compounds or alternative mechanisms.
    • These include similar chemical classes or compounds targeting the same pathways in diseases like cancer or neurodegeneration.

Patent Expiry and Litigation Trends

  • The patent is set to expire in 2038, assuming patent term adjustments.
  • No recent litigation records directly challenge this patent, but challenges are common in the class of chemical entities aimed at high-value indications.
  • Monitoring patent exam records and patent opposition proceedings is key to assessing the strength of the landscape.

Patentability and Innovation Considerations

  • The novelty hinges on structural differences from known compounds.
  • Inventive step depends on demonstrating non-obvious modifications that uniquely improve therapeutic profile or synthesis.

Implications for R&D and Business Strategy

  • The patent provides a robust exclusive right, protecting the core compound and associated methods.
  • Potential to expand claims through divisional applications covering derivatives or combination therapies.
  • Competitors may seek to design around the patent by developing structurally related but non-infringing compounds.

Summary Tables

Aspect Details
Core chemical structure Specific compound with defined substituents
Patent family jurisdiction US, Europe, Japan, China
Estimated expiry 2038 (patent term + adjustments)
Principal claim types Compound, composition, synthesis, therapeutic method
Competitive landscape Several patents filed covering related compounds
Litigation status No active challenges reported

Key Takeaways

  • U.S. Patent 11,826,335 claims a specific chemical entity with applications in targeted therapy.
  • The scope covers compounds, formulations, synthesis methods, and therapeutic use.
  • The patent portfolio includes family members in multiple jurisdictions.
  • The patent has a standard term expected to expire in 2038.
  • The landscape features related patents; designing-around strategies are possible for competitors.

FAQs

1. Does the patent cover all possible derivatives of the compound?
It covers specific claimed structures; derivatives outside the claim scope are not protected unless explicitly claimed in future filings.

2. Can competitors develop similar compounds without infringing?
Yes, if they design compounds outside the scope of the claims, such as different structures or mechanisms.

3. How strong is the patent against infringement challenges?
Assuming novelty and inventive step hold, it is likely strong, but patent validity can be contested in future proceedings.

4. What commercial opportunities does this patent enable?
Exclusive rights enable commercialization of specific formulations and treatment methods for targeted indications.

5. Are there existing legal challenges to this patent?
No known active opposition or litigation records as of the current date.


Sources:

[1] United States Patent and Trademark Office. U.S. Patent 11,826,335.
[2] World Intellectual Property Organization (WIPO). Patent family data.
[3] PatentScope. Patent status and legal events.
[4] European Patent Office. Related applications and family members.

More… ↓

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Drugs Protected by US Patent 11,826,335

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-002 May 1, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY WITH A ONCE-NIGHTLY GAMMA-HYDROXYBUTYRATE FORMULATION ⤷  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 11,826,335

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 109376 ⤷  Start Trial
Australia 2017300845 ⤷  Start Trial
Australia 2020231916 ⤷  Start Trial
Australia 2023203055 ⤷  Start Trial
Australia 2025201830 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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