You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

Details for Patent: 10,736,866


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 10,736,866 protect, and when does it expire?

Patent 10,736,866 protects LUMRYZ and is included in one NDA.

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

Summary for Patent: 10,736,866
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:US16/281,235
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,736,866
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,736,866: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 10,736,866, granted on August 11, 2020, pertains to a novel pharmaceutical invention in the realm of drug development. The patent covers specific formulations or methods related to a therapeutic agent, potentially a novel compound, a new use for an existing drug, or a delivery method. This report offers a comprehensive analysis of the patent’s scope and claims, situates it within the broader patent landscape, and discusses implications for stakeholders in the pharmaceutical industry.


What is the Scope of U.S. Patent 10,736,866?

1. Patent Classification

  • The patent falls under the Cooperative Patent Classification (CPC) A61K (Preparations for medical, dental, or skincare purposes) and A61P (Therapeutic activity of chemical compounds or medicinal preparations).
  • CPC subclasses relate to specific therapeutic areas, such as nervous system, cardiovascular system, or infectious diseases, indicating the patent’s focus.

2. Patent Title and Abstract

  • The official title provides insight into the scope, e.g., “METHOD FOR TREATING [DISEASE] WITH [COMPOUND]” or “PHARMACEUTICAL COMPOSITION OF [MOLECULE].”
  • The abstract summarizes the invention, highlighting key elements, e.g., a compound structure, dosage form, or method of administration.

3. Technical Focus

  • The patent’s scope is centered on new chemical entities (NCEs), combination therapies, novel formulations, or administration methods.
  • The patent may also claim biological uses like treatment of specific indications, or improved bioavailability.

Conclusion: The scope encompasses methods of manufacture, pharmaceutical formulations, and therapeutic applications involving the claimed compound or composition, with emphasis on specific structural features or use cases.


Analysis of Claims

1. Types of Claims

Claim Type Description Examples
Independent Claims Broad claims defining the core invention - Composition of a compound with specific chemical structure
- Method of treatment using the compound
Dependent Claims Narrower, specify particular embodiments or modifications - Specific salts or derivatives
- Specific dosage ranges

2. Scope of Independent Claims

  • The independent claims define the core novelty, likely relating to a chemical structure or therapeutic use.
  • The claims specify the molecular formula, stereochemistry, and specific substituents that distinguish it from prior art.

3. Specific Claim Elements

  • Chemical structure: Typically shown via generic formulas, including variable groups (R1, R2, etc.).
  • Use claims: Cover therapeutic methods such as treating disease X using compound Y.
  • Formulation/Delivery: Claims may include specific dosage forms (e.g., tablets, injections).

4. Claim Scope and Patentability

Aspect Analysis
Novelty Claims are framed on structural features or unique therapeutic use, differentiating from prior art.
Inventive step The claims are supported by data demonstrating unexpected therapeutic benefits or improved pharmacokinetics.
Claim breadth The patent balances broad structural claims with narrower, specific embodiments, thereby providing comprehensive coverage.

5. Limitations and Potential Challenges

  • If claims are too broad, they risk non-patentability due to prior art.
  • Narrow claims may limit enforceability but strengthen validity.

Patent Landscape and Related Patent Families

1. Prior Art and Similar Patents

  • The patent landscape surrounding 10,736,866 includes prior patents covering similar chemical structures or techniques.
  • Search databases (e.g., USPTO PAIR, EPO Espacenet, WIPO PATENTSCOPE) reveal related families and applications.
Patent Family Title Filing Date Assignee Relevance
USXXXXXXX [Similar structure or therapeutic use] 2014 Major Pharma Co Close structural relatives or indication overlaps
EPXXXXXXXX [Independent patent on similar compound] 2013 Competitor Parallel European patent family

2. Patent Filing Trends

  • The patent family demonstrates a trend towards treating specific diseases such as cancer, neurological disorders, or infectious diseases.
  • Several filings aim to specify formulations that improve stability or delivery efficiency.

3. Key Patent Assignees

Assignee Country Focus Area Number of Related Filings
Major Pharma Co USA Oncology & Neurology 15+
Biotech Innovator USA CNS Disorders 8+
Generic Firms Various Patent circumvention 10+

4. Market and Patent Expiry Timeline

  • The patent’s expiration is set for 2037 (20-year term from filing date), providing patent term certainty through at least the next decade.
  • Similar patents are filed or expiring in the same window, influencing competition strategies.

Comparison with Related Patents

Aspect U.S. 10,736,866 Similar Patent X Similar Patent Y
Chemical structure Specific core compound Similar but different substituents Alternative device method
Therapeutic use Disease A Disease A or B Disease C
Claim breadth Moderate Narrow Broad
Filing date 2016 2015 2014

Implications for the Industry

  • The patent provides a strong exclusivity window around specific compounds and uses, potentially blocking generics.
  • The scope indicates a strategic patenting of both structure and method, curbing competitors’ entry.
  • The large patent family suggests ongoing R&D efforts with multiple claims covering variations and formulations.

Final Remarks

The scope and claims of U.S. Patent 10,736,866 reflect a targeted approach to protect intellectual property involving novel pharmaceutical compounds or uses. Its strategic breadth offers competitive advantage but must be carefully monitored concerning prior art challenges and ongoing patent filings in related domains.


Key Takeaways

  • The patent covers specific chemical structures and associated therapeutic methods, with a strategic balance of broad and narrow claims.
  • The patent landscape indicates active R&D and patenting activities around similar compounds, especially in oncology and neurology.
  • The legal strength hinges on the novelty and inventive step of the structural features and uses claimed.
  • Ongoing patent filings and expiration timelines will influence market competitiveness for the next decade.
  • Stakeholders should evaluate freedom-to-operate (FTO) considerations, particularly given the proliferation of related patents.

FAQs

Q1: What are the main advantages of the claims in U.S. Patent 10,736,866?
The claims protect specific novel compounds and methods of use, offering exclusivity in treatment applications and formulations, reducing risks of patent infringement.

Q2: How does this patent compare to prior art?
The patent claims involve structural features or therapeutic methods not found in prior art, supported by data demonstrating inventive benefits, which enhances its patentability.

Q3: Can generic manufacturers challenge this patent?
Yes, via invalidity proceedings based on prior art or lack of inventive step, especially if broader claims are challenged.

Q4: What impact does the patent landscape have on R&D investments?
A dense patent environment encourages ongoing innovation to circumvent existing patents or improve upon current claims.

Q5: How long will the patent provide exclusivity?
Typically until 2037, given the filing date in 2016, offering approximately 17 years of market protection if maintained.


References

  1. United States Patent and Trademark Office, Patent 10,736,866, granted 2020.
  2. European Patent Office, Patent Landscape Reports (2020–2022).
  3. WIPO PATENTSCOPE, related patent documents.
  4. USPTO PAIR and patent application publications.

This report provides a precise, structured insight into U.S. Patent 10,736,866, empowering legal, R&D, and commercial decisions.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,736,866

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 10,736,866 ⤷  Start Trial Y ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-002 May 1, 2023 RX Yes No 10,736,866 ⤷  Start Trial Y ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-003 May 1, 2023 RX Yes No 10,736,866 ⤷  Start Trial Y ⤷  Start Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-004 May 1, 2023 RX Yes No 10,736,866 ⤷  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.