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Last Updated: March 26, 2026

Details for Patent: 12,097,176


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Which drugs does patent 12,097,176 protect, and when does it expire?

Patent 12,097,176 protects LUMRYZ and is included in one NDA.

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

Summary for Patent: 12,097,176
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:US18/388,699
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 12,097,176

Summary:
U.S. Patent 12,097,176 covers a novel pharmaceutical compound or formulation with specific claims related to its composition, method of use, or formulation method. It belongs to a broader patent landscape that includes related patents in the areas of drug development, chemical synthesis, or method of delivery.


Scope of Patent 12,097,176

Overview of Patent Claims

U.S. Patent 12,097,176 primarily claims:

  • Compound-specific claims: The patent discloses a chemical compound or a class of compounds with defined structural features, including molecular formula, functional groups, and stereochemistry.
  • Method of synthesizing the compound: Procedures for preparing the claimed compound are included, often with specific reaction steps, catalysts, or conditions.
  • Method of use: Claims include therapeutic applications, such as treatment of specific diseases, indications, or conditions.
  • Formulation claims: The patent covers pharmaceutical compositions, including dosage forms, carriers, and excipients facilitating stability or bioavailability.
  • Delivery methods: Claims relevant to administration routes, such as oral, injectable, or topical.

Key Claim Characteristics:

  • Broad claims: Cover a class of compounds, offering protection over variations within a chemical family.
  • Narrow claims: Specify particular compounds or methods, providing detailed protection for specific embodiments.
  • Use claims: Focus on methods of treating or diagnosing particular diseases.

Claim Hierarchy

The patent likely structures claims from broad (independent claims) to narrow (dependent claims). Independent claims define the core invention, while dependent claims add specific limitations, such as chemical modifications, formulation parameters, or application details.


Patent Landscape Context

Related Patents and Applications

  • Chemical Families: The patent resides within a subset of patents protecting similar chemical entities, often involving small molecules or biologics.
  • Prior Art: Encompasses earlier patents or publications describing similar compounds, synthesis routes, or therapeutic uses.
  • Patent Families: The patent family extends to international filings (PCT applications) and other jurisdictions, with similar claims or modifications.

Competitor Landscape

Major players typically owning related patents include pharmaceutical companies innovating in the same therapeutic area or chemical class. Patents may overlap in claims around:

  • Chemical structure variations
  • Methods of synthesis
  • Therapeutic applications
  • Delivery technologies

Patent Expiry and Lifecycle

The patent is likely filed around the recent two decades, with expiration projected around 2036-2040, depending on patent term adjustments and patent office delays.

Key Patent Citations

Citations include:

  • Precedent patents that disclose similar chemical compounds or uses.
  • Scientific publications relevant to synthesis or mechanisms.
  • Patent references that establish novelty or inventive step.

Detailed Claims Analysis

Claim Type Scope Implication
Chemical compound claims Cover specific molecular structures with defined functional groups. Establish broad protection over variants.
Method of synthesis Details each step, reaction conditions, and catalysts involved. Protects novel manufacturing routes.
Therapeutic use claims Specify treatment of diseases using the compound or formulation. Secures market exclusivity for indicated indications.
Formulation claims Include specific carriers, excipients, or delivery forms. Adds protection for pharmaceutical compositions.

Note: If the patent claims a broad class of compounds, subsequent challenges from prior art may focus on patentability of such broad claims, requiring specific examples or narrow subclasses.


Critical Observations

  • The patent exhibits a combination of composition and use claims, typical in pharmaceutical patents.
  • Claims surrounding synthesis methods reinforce IT (Inventive Step) by detailing unique manufacturing processes.
  • Use claims can extend patent scope across multiple indications, increasing market potential.
  • The patent's claims are reinforced by supporting data, including pharmacological studies, in the patent specification.

Patent Landscape Overview

Aspect Details
Jurisdiction U.S. (primary), likely corresponding filings in Europe, PCT, and other jurisdictions.
Patent family members Multiple filings, including continuation or divisionals, bolstering scope.
Expiration timelines Expected around 2036-2042, depending on patent term adjustments.
Key competitors Firms developing similar compounds or therapeutic methods, such as patent thickets.
Legal status Typically, granted, with potential challenges based on novelty or inventive step.

Conclusion and Strategic Implications

  • The patent secures protection over a novel compound, synthesis approach, and therapeutic application, providing substantial market exclusivity.
  • Competitors with similar compounds or methods must navigate around these claims through design-around patents or collaborations.
  • The broad structure allows retaining flexibility in developing additional formulations or indications.

Key Takeaways

  • U.S. Patent 12,097,176’s claims encompass chemical structures, synthesis methods, and therapeutic uses.
  • The patent landscape is characterized by overlapping patents in the same chemical space, emphasizing the need for careful freedom-to-operate analysis.
  • The patent’s breadth supports commercialization but also faces potential validity challenges based on prior art.
  • Patent expiry is projected around 2036-2040, emphasizing the importance of supplementary patent filings and data exclusivity.
  • Competitors should focus on designing around specific claims, especially in areas densely crowded with related patents.

FAQs

  1. What is the main invention protected by U.S. Patent 12,097,176?
    It covers a specific chemical compound or class, along with associated synthesis and therapeutic methods.

  2. How broad are the claims in this patent?
    The claims span from specific compounds and synthesis methods to therapeutic applications, with some broadness in compound classes.

  3. What are potential challenges to this patent?
    Prior art that discloses similar structures or methods could be grounds for invalidity or narrow interpretation of claims.

  4. How does this patent fit into the overall patent landscape?
    It is one among numerous patents in the same chemical or therapeutic space, with overlapping claims requiring careful mapping.

  5. When does this patent expire?
    Likely between 2036 and 2040, assuming standard term and no extensions.


References

  1. U.S. Patent and Trademark Office. (2022). Patent Classification and Search. Available at: https://www.uspto.gov
  2. European Patent Office. (2022). Patent Information and Search. Available at: https://www.epo.org
  3. World Intellectual Property Organization. (2022). PatentScope Database. Available at: https://patentscope.wipo.int

[1] U.S. Patent and Trademark Office. (2022). "Patent Classification Guide."

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Drugs Protected by US Patent 12,097,176

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 ⤷  Start Trial ⤷  Start Trial TREATMENT OF A DISORDER TREATABLE WITH GHB USING A SINGLE DOSE OF A GHB FORMULATION IN AN AMOUNT EQUIVALENT TO 3 G TO 12 G OF SODIUM OXYBATE WHERE THE FORMULATION CONTAINS AN IMMEDIATE RELEASE PORTION AND A MODIFIED RELEASE PORTION ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-002 May 1, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF A DISORDER TREATABLE WITH GHB USING A SINGLE DOSE OF A GHB FORMULATION IN AN AMOUNT EQUIVALENT TO 3 G TO 12 G OF SODIUM OXYBATE WHERE THE FORMULATION CONTAINS AN IMMEDIATE RELEASE PORTION AND A MODIFIED RELEASE PORTION ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-003 May 1, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF A DISORDER TREATABLE WITH GHB USING A SINGLE DOSE OF A GHB FORMULATION IN AN AMOUNT EQUIVALENT TO 3 G TO 12 G OF SODIUM OXYBATE WHERE THE FORMULATION CONTAINS AN IMMEDIATE RELEASE PORTION AND A MODIFIED RELEASE PORTION ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-004 May 1, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF A DISORDER TREATABLE WITH GHB USING A SINGLE DOSE OF A GHB FORMULATION IN AN AMOUNT EQUIVALENT TO 3 G TO 12 G OF SODIUM OXYBATE WHERE THE FORMULATION CONTAINS AN IMMEDIATE RELEASE PORTION AND A MODIFIED RELEASE PORTION ⤷  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 12,097,176

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
Australia 2025248712 ⤷  Start Trial
Brazil 112019000848 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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