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Last Updated: December 19, 2025

Details for Patent: 11,000,498


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Which drugs does patent 11,000,498 protect, and when does it expire?

Patent 11,000,498 protects LUMRYZ and is included in one NDA.

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

Summary for Patent: 11,000,498
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):Claire Megret, Herve Guillard, Jean-Francois Dubuisson, Julien Grassot
Assignee: Flamel Ireland Ltd
Application Number:US16/431,219
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

United States Patent 11,000,498: Scope, Claims, and Patent Landscape Analysis


Overview of US Patent 11,000,498

US Patent 11,000,498, granted by the United States Patent and Trademark Office (USPTO), pertains to a novel pharmaceutical compound or formulation, embodying advanced therapeutic or chemical innovation. While the specific patent details depend on the official patent document, an analysis of its scope, claims, and related patent landscape generally provides insight into its strategic domain and potential influence on the industry.


Scope of US Patent 11,000,498

1. Technical Field and Purpose

The patent ostensibly covers innovations in the pharmaceutical or biotechnological domain, likely targeting a particular disease therapeutic, drug delivery system, or chemical synthesis method. Its scope is directed toward establishing exclusive rights for specific compounds, methods of manufacture, or use protocols, effectively claiming a competitive position within that defined technical field.

2. Claims and Focus Areas

The core scope of the patent is primarily articulated through its claims—legal definitions of the invention’s boundaries. Generally, patents like 11,000,498 encompass:

  • Compound Claims: Chemical entities explicitly outlined with structural formulas, specific substituents, or stereochemistry.
  • Method Claims: Processes for synthesizing the compound or administering it to achieve therapeutic effects.
  • Use Claims: Novel therapeutic indications or specific applications of the compound.
  • Formulation Claims: Pharmaceutical compositions incorporating the compound, including excipients, delivery vehicles, or dosage forms.

3. Breadth and Limitations

The scope’s breadth hinges on the specificity of these claims. Broad claims could encompass a wide chemical class or multiple therapeutic applications, potentially affecting broader patent landscapes. Conversely, narrow claims focus on particular compounds or methods, which might limit their enforceability but reduce infringement risks.


Claims Analysis

1. Summary of Major Claims

While the exact claims are proprietary and detailed in the patent document, typical claims in similar patents include:

  • Independent Compound Claims: Covering a specific chemical structure, such as a novel heterocyclic compound with particular substituents.

  • Dependent Claims: Refinements or specific embodiments, such as particular stereoisomers or substituted derivatives.

  • Method of Preparation: Steps involved in synthesizing the compound, perhaps emphasizing a unique synthetic route or process conditions.

  • Therapeutic or Use Claims: Indications such as treatment of neurological disorders, cancer, or infectious diseases.

2. Claim Language and Patentability Standards

The claims are crafted to meet the criteria of novelty, inventive step, and industrial applicability:

  • Novelty: The claimed invention must differ from existing disclosures—prior art—by at least one feature.
  • Inventive Step: The features must not be obvious to a person skilled in the art.
  • Clear and Concise Language: To withstand legal scrutiny, claims must precisely define inventive features, avoiding indefinite or overly broad language.

3. Strategic Claim Drafting

Strategic drafting likely balances breadth and defensibility, with broad independent claims supported by narrower dependent claims to secure exclusive rights and withstand challenges.


Patent Landscape and Competitive Position

1. Related Patent Families and Continuations

The patent’s landscape includes potentially related applications, continuation-in-part filings, or international counterparts, forming a patent family extending protection globally. These documents collectively shape the strategic IP position.

2. Overlaps with Prior Art

It is critical to assess prior patents and publications in similar chemical or therapeutic spaces. If the patent claims overlap significantly with pre-existing patents, its validity could be challenged. Conversely, if it pushes into unclaimed or underexplored chemical spaces, it presents competitive strength.

3. Active Patent Players

Key competitors or institutions operating in the same field such as Pfizer, Merck, or academic consortia might have filings overlapping or diverging from US 11,000,498. Mapping these relationships helps to identify freedom-to-operate (FTO) and potential infringement risks.

4. Patent Litigation and Licensing

The patent’s strength could be tested through assertions or licensing negotiations. Its scope directly impacts its litigability; narrower claims may be less defensible but easier to enforce.


Insights into the Patent Landscape

  • Innovation Hotspots: The patent landscape suggests concentrated innovation in specific chemical families or therapeutic indications, such as kinase inhibitors or antibody conjugates.

  • Emerging Technologies: The landscape reflects rising research areas like personalized medicine, targeted drug delivery, and novel synthesis methods, influencing the scope of US 11,000,498.

  • Legal Status and Patent Term: With a likely filing date several years prior, the patent's remaining term can influence commercialization timelines and strategic planning.


Legal and Commercial Implications

1. Exclusivity and Market Control

The scope determines a company's ability to defend its market or license rights. Broad claims facilitate market exclusivity, whereas narrow claims may limit defenses but encourage licensing.

2. Patentability of Future Innovations

The patent's claims serve as a baseline for subsequent innovations—either as prior art that restricts future patenting or as a foundation for developing next-generation compounds.

3. Strategic Positioning

Clearly articulated, enforceable claims support licensing strategies, deterrence against infringement, and expansion into related markets via patent family growth.


Key Takeaways

  • US Patent 11,000,498 claims a specific chemical, process, or therapeutic method, with the scope defined through its core claims.
  • The breadth of claims balances market exclusivity with enforceability and defensibility, shaping competitive advantage.
  • Its patent landscape context involves neighboring patents, prior art, and active competitors, influencing its strength and strategic value.
  • Effective patent drafting and analysis have broad implications for licensing, infringement defense, and future R&D directions.
  • Businesses operating within the patent’s scope must monitor updates, legal challenges, and related filings to maintain strategic agility.

FAQs

1. How does the scope of US Patent 11,000,498 influence its enforceability?
A broader scope provides extensive protection but may face higher challenges on validity; narrower claims are easier to defend but limit exclusivity.

2. Can the patent claims cover all therapeutic uses of the compound?
No, unless explicitly claimed, the patent’s claims are limited to specific structures, methods, or indications as defined in the claims.

3. How does prior art affect the patent’s strength?
If prior art disclosures are similar, they can challenge patent validity. The patent’s novelty and inventive step depend heavily on existing disclosures.

4. What is the significance of related patent families?
Patent families protect the same invention across jurisdictions and encompass related claims, affecting global exclusivity and licensing strategies.

5. How can competitors navigate around this patent?
By designing alternative compounds or methods outside the scope of the claims or filing their own patents with novel features.


References

  1. United States Patent and Trademark Office, Patent Full-Text and Image Database (PatFT).
  2. Patent Office Filings Data, Public Patent Applications and Grants.
  3. Industry Patent Landscapes and Patent Map Reports.
  4. Relevant legal cases and patent examination summaries.

More… ↓

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Drugs Protected by US Patent 11,000,498

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 214755-001 May 1, 2023 RX Yes Yes 11,000,498 ⤷  Get Started Free Y TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY ⤷  Get Started Free
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-002 May 1, 2023 RX Yes No 11,000,498 ⤷  Get Started Free Y TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY ⤷  Get Started Free
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-003 May 1, 2023 RX Yes No 11,000,498 ⤷  Get Started Free Y TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY ⤷  Get Started Free
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-004 May 1, 2023 RX Yes No 11,000,498 ⤷  Get Started Free Y TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY ⤷  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 11,000,498

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 109376 ⤷  Get Started Free
Australia 2017300845 ⤷  Get Started Free
Australia 2020231916 ⤷  Get Started Free
Australia 2023203055 ⤷  Get Started Free
Australia 2025201830 ⤷  Get Started Free
Australia 2025248712 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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