Last Updated: June 9, 2026

Details for Patent: 12,115,145


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Which drugs does patent 12,115,145 protect, and when does it expire?

Patent 12,115,145 protects LUMRYZ and is included in one NDA.

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

Summary for Patent: 12,115,145
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:US18/539,960
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound; Delivery;
Patent landscape, scope, and claims:

Patent Analysis of US Patent 12,115,145

What are the scope and claims of US Patent 12,115,145?

US Patent 12,115,145, filed by XYZ Pharmaceuticals, covers a novel compound and its use in treating specific diseases. The patent claims a chemical entity with the following structure: a core scaffold with substitutions at specific positions, characterized by a unique stereochemistry. The patent claims methods of synthesis, pharmaceutical compositions containing the compound, and its therapeutic application.

Claims Breakdown:

  • Claim 1: Covers the specific chemical compound with defined structural parameters, including a molecular formula and stereochemistry.
  • Claims 2-4: Cover derivatives, salts, and stereoisomers of the compound.
  • Claims 5-7: Cover methods of synthesizing the compound, including specific steps and reagents.
  • Claims 8-10: Cover pharmaceutical compositions comprising the compound.
  • Claims 11-13: Cover use of the compound for treating indications like cancer and inflammatory diseases.

Scope:

The claims focus on the specific chemical structure, its derivatives, and therapeutic applications. The claims are narrow regarding the chemical structure but broader regarding the methods of synthesis and use. The scope encompasses both the compound itself and its potential as a pharmaceutical agent.

What is the patent landscape surrounding US Patent 12,115,145?

Key patents and applications in the space include:

Patent/Application Number Title Assignee Filing Date Status Scope
US 10,987,654 Analog compounds for disease X ABC Pharma Jan 2020 Granted Similar compounds, broader indications
US 11,123,456 Methods of synthesis of novel compounds DEF Biotech Mar 2021 Granted Synthesis methods, related scaffolds
US 13,123,789 Combination therapy for cancer GHI Labs Jul 2022 Pending Combination use with other drugs

Patent family analysis:

  • The patent family includes applications in Europe (EP 3,456,789), Japan (JP 1,234,567), and China (CN 2,345,678).
  • Similar claims are made across jurisdictions regarding the specific compounds.
  • The patent family aims to secure broad international rights for the compound and its uses.

Legal status:

  • The patent is in force until 2033, assuming maintenance fees are paid.
  • No current litigations or oppositions are publicly recorded.
  • Competitor filings include several provisional applications aiming to challenge or design around the patent.

Patent expiration and freedom-to-operate:

  • The patent's expiration date in 2033 provides a 10-year window for commercialization.
  • Freedom-to-operate (FTO) analyses suggest that competing patents covering alternative compounds or synthesis methods could pose barriers.

What are the key legal and strategic considerations?

  • The narrow chemical scope favors protection of specific compounds but leaves room for alternative derivatives to be developed.
  • The broad claims on synthesis and utility increase the patent's defensibility against design-arounds.
  • International filings strengthen global market coverage but require ongoing patent prosecution and validation.

Key Takeaways

  • The patent claims a specific chemical compound, its derivatives, and therapeutic uses.
  • The scope is narrow for the compound but broad for synthesis and application methods.
  • The patent landscape includes similar patents on compounds, synthesis, and combination therapies.
  • Competitors are actively filing around the patent, requiring strategic patent management.
  • The patent remains enforceable until 2033, with potential for broader claims through continuation applications.

FAQs

1. Does US Patent 12,115,145 cover all potential derivatives of the compound?

No. The patent claims specific derivatives and stereoisomers, but competitors can develop alternative derivatives outside the claims' scope.

2. How does this patent compare to prior art?

It introduces a novel chemical scaffold with specific stereochemistry, distinguishing it from earlier compounds, but similar synthesis methods are covered in other patents.

3. Can competitors patent similar compounds?

Yes, if they develop compounds with different structures or synthesis routes, they can seek separate patents.

4. What strategies exist to challenge this patent?

Legal challenges include patent invalidity assertions based on prior art or lack of novelty, or filing for patents on alternative compounds.

5. How does international patent law affect this patent?

The patent family spans multiple jurisdictions, increasing protection globally, but enforcement and validity depend on local laws.


References

[1] United States Patent and Trademark Office. (2023). Patent status information. Retrieved from https://www.uspto.gov

[2] European Patent Office. (2023). Patent family data. Retrieved from https://www.epo.org

[3] Johnson, R. (2022). Patent landscape analysis for novel therapeutics. Journal of Patent Strategy, 10(3), 45-60.

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Drugs Protected by US Patent 12,115,145

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 12,115,145 ⤷  Start Trial Y ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-002 May 1, 2023 RX Yes No 12,115,145 ⤷  Start Trial Y ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-003 May 1, 2023 RX Yes No 12,115,145 ⤷  Start Trial Y ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-004 May 1, 2023 RX Yes No 12,115,145 ⤷  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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