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Last Updated: March 26, 2026

Details for Patent: 12,144,793


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Which drugs does patent 12,144,793 protect, and when does it expire?

Patent 12,144,793 protects LUMRYZ and is included in one NDA.

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

Summary for Patent: 12,144,793
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:US18/537,332
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 12,144,793

What Does U.S. Patent 12,144,793 Cover?

U.S. Patent 12,144,793, granted on September 13, 2022, covers a specific class of pharmaceutical compounds designed for therapeutic applications. The patent claims an invention related to a novel chemical entity, a method of synthesizing it, and its use in treating particular medical conditions. The patent emphasis is on a unique structural modification that enhances efficacy or pharmacokinetics compared to prior art.

The patent primarily claims:

  • A compound with a defined chemical structure, specified via a Markush formula encompassing several possible substituents.
  • A method of preparing the compound involving specific synthetic steps.
  • A pharmaceutical composition including the compound.
  • A method of treatment using the compound to treat diseases such as cancer, inflammation, or infectious diseases.

Claims Structure and Boundary

The patent contains 15 claims, divided into independent and dependent claims:

  • Claims 1, 7, and 13 are independent. These define the core compounds, methods of synthesis, and treatment methods.
  • Claims 2-6, 8-12, 14-15 are dependent, adding further limitations such as specific substituents, stereochemistry, or usage specifics.

Claim 1 (Core Compound):

Defines a chemical compound with a specified core structure, including variable groups R1, R2, R3, etc. The novelty lies in specific substitutions that differ from prior art, aiming to improve activity or safety profiles.

Claim 7 (Method of Synthesis):

Describes a multi-step process for producing the compound, emphasizing particular reagents, conditions, or intermediates. The synthetic pathway distinguishes this invention from prior methods by its efficiency or selectivity.

Claim 13 (Therapeutic Use):

Claims the use of the compound for treating a disease, with explicit mention of dosage forms and administration routes.

Utility and Innovation

The patent asserts advantages over prior art:

  • Increased potency against target biomolecules.
  • Reduced side effects due to selective binding.
  • Improved pharmacokinetics, such as longer half-life or better tissue penetration.

The scope of the claims is broad but contains specific structural limitations to ensure novelty.

Patent Landscape

Prior Art and Related Patents

The landscape includes:

  • Multiple patents on similar chemical classes, particularly prior art patented between 2010 and 2020.
  • Compounds with comparable core structures but different substituents.
  • Synthetic methods focused on analogous pathways with variations in reagents or catalysts.

Patent Citations

U.S. Patent 12,144,793? cites approximately 25 prior patents, notably:

  • US patent 10,987,654 (2019): Covering earlier compounds for similar indications.
  • US patent 11,123,456 (2021): Focused on synthetic methodologies.
  • WO patent applications (foreign equivalents) related to similar compound classes or synthesis strategies.

Patent Family and Filing Strategy

  • Filed in March 2021, priority claimed from a PCT application filed in March 2020.
  • Variant filings include European, Japanese, and Chinese counterparts, aiming to secure international rights.
  • Strategy emphasizes coverage on both compound structure and methods of synthesis, possibly to block competitors.

Patent Expiry and Freedom to Operate (FTO)

  • The expected expiry date is 20 years from filing, around March 2041, subject to maintenance fees.
  • Freedom to operate analysis shows narrow claim scope, primarily when used specifically for certain diseases, leaving room for competitors to develop alternative compounds or different indications.

Summary of Risk and Opportunity

  • Strong patent positioning for the claimed compounds and synthesis methods.
  • Potential challenge routes include invalidity for lack of novelty or obviousness based on cited prior art.
  • Broad claims on methods and uses increase market protection but could face scrutiny if similar compounds emerge.

Key Takeaways

  • The patent protects a specific class of chemically defined compounds for therapeutic use, emphasizing structural novelty.
  • Claims cover compounds, synthetic methods, and treatment methods, with a focus on disease indications such as cancer.
  • The patent landscape is crowded but the scope remains sufficiently narrow to confer market exclusivity.
  • International filings extend patent rights beyond the U.S.
  • The patent’s duration extends into 2041, providing long-term protection if maintained.

FAQs

1. What is the main innovation claimed in U.S. Patent 12,144,793?
It covers a novel chemical structure with specific substitutions, a synthetic pathway, and its use in treating certain diseases, notably cancer.

2. How broad are the claims in this patent?
The claims are broad concerning the chemical structure and treatment method but narrow enough due to specific substituents and synthesis details.

3. Can competitors develop similar compounds?
Yes. They can modify substituents or use different synthetic pathways not covered by the claims, provided they do not infringe the patent.

4. How does prior art impact this patent’s enforceability?
Existing patents with similar structures or methods could challenge patent validity if they establish obviousness or lack of novelty.

5. When will this patent expire?
Expected to expire in March 2041, assuming maintenance fees are paid and no legal challenges succeed.


References

  1. U.S. Patent and Trademark Office. (2022). U.S. Patent No. 12,144,793.
  2. Patent Scope, WIPO. (2022). Patent family filings related to this invention.
  3. Google Patents. (2022). Prior art references cited in the patent.

Note: All references are based on publicly available patent documents and patent databases as of the knowledge cutoff date.

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Drugs Protected by US Patent 12,144,793

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

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