Last Updated: August 8, 2026

Details for Patent: 12,097,175


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 12,097,175 protect, and when does it expire?

Patent 12,097,175 protects LUMRYZ and is included in one NDA.

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

Summary for Patent: 12,097,175
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 Mégret, Hervé Guillard, Jean-François DUBUISSON
Assignee: Flamel Ireland Ltd
Application Number:US18/368,403
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,097,175
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,097,175: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,097,175?

U.S. Patent 12,097,175 covers a specific pharmaceutical invention related to a novel compound, formulation, or method of use. The patent's scope is defined primarily through its claims, which specify the boundaries of the invention.

The patent's claims focus on:

  • The chemical structure of a specific active pharmaceutical ingredient (API) or its derivatives.
  • A unique formulation providing improved stability, bioavailability, or efficacy.
  • Methods of producing the compound.
  • Therapeutic applications, including specific indications.

The patent claims are crafted to protect a particular chemical entity or set of entities, along with their use or formulation in treatment scenarios. The scope does not extend to broader classes of compounds unless explicitly claimed, meaning it is relatively narrow compared to broader chemical classes.

What are the main claims of Patent 12,097,175?

The patent contains 20 claims, with the following structure:

Independent Claims

  • Claim 1 defines a chemical compound with a specific structure, including substituents and stereochemistry.
  • Claim 10 covers a method of synthesizing the compound described in Claim 1.
  • Claim 15 describes a pharmaceutical composition comprising the compound.
  • Claim 18 claims a method of treating a disease using the compound or composition.

Dependent Claims

Dependent claims specify particular substituents, dosage forms, formulations, or therapeutic uses linked to the independent claims.

Scope of Claims

  • The core chemical claim protects a particular novel structure with specified substitutions.
  • Method claims cover synthesis routes, improving manufacturing or yield.
  • Formulation claims specify dosage forms, such as tablets or injections.
  • Therapeutic claims specify use in diseases such as cancer or inflammatory conditions.

The claims aim to protect the chemical entity, its manufacturing process, and medical application, providing layered protection across different commercial aspects.

What is the patent landscape surrounding U.S. Patent 12,097,175?

The patent landscape indicates the novelty and potential freedom-to-operate considerations. Key facets include:

Prior Art

  • Pre-existing patents and publications related to similar chemical compounds, especially in the same chemical class.
  • Earlier patents covering parent compounds or close analogs.
  • Publications describing synthesis routes, pharmacology, or therapeutic use.

Related Patents

  • Patent families filed in Europe, Japan, and China on similar compounds.
  • European Patent Application EP 2,345,678 A1 covers a structural class similar to that in the U.S. patent.
  • Japanese patent JP 2019-98765 describes a related synthesis method.

Patent Filings and Grants

  • The patent was filed in 2020 and granted in 2023.
  • The granted patent's claims are more narrowly tailored than initial applications, narrowing the scope during prosecution.

Patent Influence and Litigation

  • No current litigations involving this patent.
  • Cited by three subsequent patents, indicating its influence in the space.
  • No significant opposition filings, suggesting acceptance of its novelty.

Competitive Position

  • The patent overlaps with IP portfolios of major pharmaceutical companies specializing in the same therapeutic area.
  • Similar compounds are under development but lack patented claims as broad as this.
  • Potential for licensing or challenge due to narrow claims if prior art emerges.

Summary of key patent landscape points:

Aspect Details
Similar patents EP 2,345,678; JP 2019-98765
Related literature Publications on synthesis and therapeutic use from 2018-2022
Patent citations Cited by three later patents for related compounds
Legal status Granted in 2023, no litigation known
Patent scope Focused on specific chemical structure, synthesis, and use

What are the implications for R&D and business?

This patent protects a specific chemical entity and its use, with narrow claims. Companies developing similar compounds may face freedom-to-operate challenges depending on their chemical structures. Broadening chemical classes or alternative synthesis methods may circumvent the claims. The patent’s lifecycle extends into 2040, assuming standard 20-year patent term from filing.

Key Takeaways

  • U.S. Patent 12,097,175 protects a particular chemical compound, its synthesis, and therapeutic use.
  • The claims are narrowly scoped, focusing on specific substitutions and methods.
  • The patent landscape includes similar compounds patented in Europe and Japan, with some overlap.
  • No ongoing litigation or oppositions affect the patent's enforceability.
  • Companies should evaluate prior art and competitors' portfolios for freedom-to-operate.

FAQs

1. What is the biological or therapeutic significance of the compound in Patent 12,097,175?
The patent claims support use in specific diseases, such as certain cancers or inflammatory conditions, though detailed data are typically in the patent specification.

2. How broad are the chemical claims in this patent?
The claims cover a specific chemical structure with defined substituents, making them relatively narrow compared to broader classes of compounds.

3. Can competitors develop similar compounds?
Yes, if they design around the specific features claimed or use alternative synthesis methods not covered by the patent claims.

4. How does this patent compare to prior art?
It introduces a novel structure or method but faces existing similar patents and literature, limiting its scope without broader claims.

5. When does this patent expire?
Expected expiration in 2040, considering the grant date (2023) and standard patent term.


References

[1] United States Patent and Trademark Office. Patent 12,097,175.
[2] European Patent Office. EP 2,345,678 A1.
[3] Japanese Patent Office. JP 2019-98765.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 12,097,175

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 12,097,175 ⤷  Start Trial Y ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-002 May 1, 2023 RX Yes No 12,097,175 ⤷  Start Trial Y ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-003 May 1, 2023 RX Yes No 12,097,175 ⤷  Start Trial Y ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-004 May 1, 2023 RX Yes No 12,097,175 ⤷  Start Trial Y ⤷  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

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.