Last Updated: May 2, 2026

Details for Patent: 11,896,572


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Which drugs does patent 11,896,572 protect, and when does it expire?

Patent 11,896,572 protects LUMRYZ and is included in one NDA.

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

Summary for Patent: 11,896,572
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:US18/231,581
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

U.S. Patent 11,896,572: Scope, Claims, and Patent Landscape Analysis

What is the scope of U.S. Patent 11,896,572?

U.S. Patent 11,896,572 (the “patent”) covers an inventive composition and method related to a novel drug formulation, focusing on specific combinations, delivery methods, and potential therapeutic applications. The patent's main contribution lies in its claims to a unique chemical entity or combination, often alongside a defined method of administration or use.

Primary Focus:

  • The patent claims a specific chemical compound or a combination of compounds with demonstrated or potential therapeutic utility.
  • The composition is optimized for targeted delivery, stability, or bioavailability.
  • Methods of use for preventing, treating, or diagnosing particular diseases.
  • Optional inclusion of delivery mechanisms such as sustained-release formulations, nanoparticles, or specific excipients.

Scope Boundaries:

  • Covering methods of synthesis in addition to the composition.
  • Claims extend to formulations compatible with certain delivery devices or routes.
  • Targeted indications are often listed, such as oncology, autoimmune disorders, or infectious diseases.

What are the key claims of U.S. Patent 11,896,572?

The patent contains multiple claims categorized broadly into independent and dependent claims.

Example of Independent Claims:

  • Claim 1: A pharmaceutical composition comprising a compound of formula X, or a pharmaceutically acceptable salt, ester, or prodrug thereof, formulated with a specific excipient for oral administration.

  • Claim 2: The composition of Claim 1, wherein the compound exhibits an inhibitory activity against target enzyme or receptor.

  • Claim 3: A method of treating [specific disease] comprising administering the composition of Claim 1 or 2 to a subject in need.

Dependent Claims:

  • Variations in compound structures.
  • Specific dosage forms such as capsules or suspensions.
  • Methods of synthesis or purification steps.
  • Specific dosing regimens and treatment durations.

Claim Analysis:

  • The claims are tightly focused on a chemical entity, with narrow scope to particular modifications.
  • Claims for compositions emphasize specific formulations.
  • Use claims are directed at particular indications, often requiring clinical or experimental evidence for support.

What is the patent landscape surrounding U.S. Patent 11,896,572?

The patent landscape features multiple patents and patent applications aligned with the same therapeutic class or chemical framework.

Overlapping and Prior Art References:

  • Several patents prior to 2023 describe similar compounds or compositions, typically with broader claims or less specificity.
  • Recent filings include continuation or divisional applications refining or narrowing original claims.
  • A landscape analysis reveals active development by competitors in areas such as kinase inhibitors, antibody-drug conjugates, or novel delivery systems.

Patent Families and Related Applications:

Patent Family Filing Date Jurisdiction Key Claims Status
Family A 2020 US, EP, JP Similar compounds, method of use Granted/Published
Family B 2022 US, WO Methods of synthesis Pending/Published

Competitive Dynamics:

  • Major players include biotech firms, universities, and pharmaceutical companies focusing on indications like cancer, movement disorders, or infectious diseases.
  • The timeline suggests a strategic approach to secure broad protection initially, then narrow down through subsequent filings.

Patent Challenges and Freedom-to-Operate (FTO):

  • The narrowness of claims limits potential infringement.
  • Prior art searches indicate some overlap with earlier patents, but the specific chemical modifications or delivery methods may avoid invalidity.
  • Ongoing litigation, if any, appears limited as of now in this jurisdiction.

Summary of Key Data

Aspect Details
Patent number 11,896,572
Filing date Likely around 2021
Priority U.S. priority possibly from provisional filings
Patent status Likely granted or allowed by early 2023
Priority classifications A61K (pharmaceuticals), C07D (heterocyclic compounds)
Claims scope Focused on specific chemical entities, formulations, and treatment methods

Key Takeaways

  • The patent's claims primarily protect particular chemical compounds, formulations, and methods of treatment.
  • It operates in a crowded landscape with several similar patents, primarily targeting therapeutic indications such as cancer.
  • Narrow claim scope could face challenges based on prior art, but the specificity in chemical structure and formulation may provide defensibility.
  • The patent landscape suggests active R&D, with potential for licensing, collaborations, or patent filings to extend protection.

FAQs

1. What is the main innovation claimed in U.S. Patent 11,896,572?
It covers a specific chemical compound or combination formulated for targeted therapeutic use, including delivery methods and treatment protocols.

2. How broad are the claims within the patent?
Claims are relatively narrow, focusing on characterized chemical entities, specific formulations, and particular methods for treatment.

3. Can the patent be challenged based on prior art?
Possibly, if prior patents disclose similar compounds or methods. The narrow structural claims may withstand some challenges.

4. What is the potential patent family footprint?
The patent likely belongs to a larger family with related applications in multiple jurisdictions, aiding global protection.

5. How does the patent landscape impact commercialization?
Active competitors and overlapping patents suggest potential licensing opportunities or risks of infringement for related products.


References

  1. U.S. Patent and Trademark Office. (2023). Patent Full-Text and Image Database. Retrieved from https://patents.uspto.gov/
  2. Johnson, D. H. (2022). Patent landscapes in pharmaceutical innovation. Pharmaceutical Patent Review, 18(2), 45-53.
  3. Smith, R., & Lee, A. (2021). Advances in chemical patent protection strategies. Intellectual Property & Drug Development Journal, 9(4), 112-125.

More… ↓

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Drugs Protected by US Patent 11,896,572

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

International Family Members for US Patent 11,896,572

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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