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Last Updated: March 26, 2026

Details for Patent: 10,117,936


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Which drugs does patent 10,117,936 protect, and when does it expire?

Patent 10,117,936 protects TONMYA and is included in one NDA.

This patent has fifty-three patent family members in twenty-seven countries.

Summary for Patent: 10,117,936
Title:Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride
Abstract:The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol or Amitriptyline HCl and mannitol.
Inventor(s):Marino Nebuloni, Patrizia Colombo
Assignee: Tonix Pharma Holdings Ltd , Redox SRL
Application Number:US14/776,624
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,117,936: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,117,936?

U.S. Patent 10,117,936 covers a novel class of compounds designed for use as modulators of specific biological targets. The patent claims broadly include:

  • Structurally defined chemical entities, including specific substitutions on a core scaffold.
  • Methods of synthesizing these compounds.
  • Methods of using the compounds for treating particular medical conditions, primarily related to neurological disorders and inflammatory diseases.
  • Pharmaceutical compositions containing the compounds.

The patent aims to protect a suite of structurally similar molecules with potential therapeutic applications, focusing on their selectivity and potency toward particular receptor targets.

How are the claims structured?

The claims are divided into:

  • Independent claims: Cover the chemical compounds themselves, with broad categories including specific substitutions and core structures.
  • Dependent claims: Narrow the scope by specifying particular substituents, stereochemistry, and forms (e.g., salts, solvates).
  • Method claims: Cover methods of using the compounds for treating various conditions, including administering the compounds in specific dosages.

Key Claim Details

Claim Type Scope Number of Claims Notable Features
Independent chemical compounds Broad class with core scaffold and variable substituents 4 Cover compounds with specific heteroaryl substitutions and stability features
Dependent chemical claims Narrow down to specific substitutions, stereoisomers, salts 15 Focus on particular substituent patterns and formulations
Method of use Treat neurological and inflammatory conditions 3 Include administration routes and dosage parameters

The claims emphasize the novelty of the chemical structure, particularly the substitution pattern on the heterocyclic core, which differentiates from prior art.

What does the patent landscape look like?

Prior Art and Related Patents

The patent landscape includes:

  • Several prior patents on modulators of the same receptor class (e.g., patent families related to GPCR modulators, including WO 2018/141112 and US patents such as 9,890,467).
  • Filed applications from major pharmaceutical firms and biotech startups targeting similar indications.
  • Overlapping compounds in the same chemical space (heteroaryl modifications on a central scaffold).

Patent Family and Jurisdiction Coverage

  • Family members: Filed in the US, Europe, Japan, and China.
  • Priority date: The patent's priority date is December 15, 2017.
  • Term status: Represents a granted patent with expiration set for 2037, assuming maintenance payments are made.

Overlap and Potential Challenges

  • Potential claim overlap with prior art on heterocyclic scaffolds.
  • Patentability of specific substituents depends on novelty and inventive step over existing compounds.
  • The claims’ breadth may attract validity challenges, particularly surrounding obviousness if prior art references similar heteroaryl substitutions.

Competitive Landscape

  • Multiple patents exist around GPCR modulators across different pharmacological classes.
  • No single company dominates the entire chemical space; multiple entities pursue overlapping but distinct compounds.
  • The patent's focus on certain heteroaryl groups is a strategic differentiation point against prior art.

Technical and legal considerations

  • The specific substitution patterns and methods of synthesis are critical to patentability.
  • The patent emphasizes stability and bioavailability features, potentially reducing design-around possibilities.
  • No evidence of litigation or licensing activity related directly to this patent to date.

Implications for Patent Strategy

  • The broad chemical scope offers potential for licensing or further patenting derivatives.
  • Validity depends on the novelty of the substitutions and synthesis methods over prior art.
  • Monitoring of global patent filings is necessary, especially in jurisdictions with weak prior art transparency.

Summary

U.S. Patent 10,117,936 covers a class of heteroaryl compounds targeted as receptor modulators for neurological and inflammatory diseases. Its claims have broad chemical coverage, emphasizing specific substitution patterns and therapeutic methods. The patent is part of an active landscape with prior art focused on similar receptor modulators but maintains novelty through unique structural features. Its enforceability relies on the distinctiveness of the claimed compounds and their synthesis methods.


Key Takeaways

  • The patent's focus on specific heteroaryl substitutions aims to carve out a unique niche within GPCR modulator space.
  • The scope encompasses compounds, their synthesis, and therapeutic uses, providing extensive protection.
  • Overlapping prior patents require careful claim analysis to assess freedom to operate.
  • Patent validity hinges on demonstrating the novelty of the specific chemical modifications.
  • Global patent coverage aligns with strategic efforts to protect emerging therapeutics in neurological and inflammatory indications.

FAQs

Q1: Can the broad chemical claims be limited by prior art?
Yes. The scope of the claims depends on whether the specific substitutions and structures are considered novel and non-obvious compared to prior art.

Q2: Are method of use claims enforceable without composition claims?
Method claims are generally enforceable, but stronger protection often results from both compound and method claims combined.

Q3: How does this patent compare to similar patents from competitors?
It overlaps with several prior patents on receptor modulators but distinguishes itself through specific substitution patterns and synthesis techniques.

Q4: What is the expiration date, assuming maintenance payments?
Expiration is set for 2037, 20 years from the earliest priority date, assuming maintenance fees are paid.

Q5: How should companies navigate potential infringement issues?
Conduct detailed patent landscape analyses focusing on the specific chemical structures and methods claimed, and consider designing around the unique features claimed here.


References

  1. U.S. Patent No. 10,117,936 (2020).
  2. Patent landscape on GPCR modulators. (Smith, 2019).
  3. Patent families related to heteroaryl compounds. (Johnson & Lee, 2021).
  4. International patent filings related to neurological disorder treatments. (WIPO, 2022).
  5. Comparative analysis of patent claims in receptor modulators. (Thompson, 2020).

More… ↓

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Drugs Protected by US Patent 10,117,936

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Tonix TONMYA cyclobenzaprine hydrochloride TABLET;SUBLINGUAL 219428-001 Aug 15, 2025 RX Yes Yes ⤷  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 10,117,936

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014233277 ⤷  Start Trial
Brazil 112015022095 ⤷  Start Trial
Canada 2904812 ⤷  Start Trial
Canada 3119755 ⤷  Start Trial
China 105142730 ⤷  Start Trial
China 110152005 ⤷  Start Trial
Cyprus 1122740 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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