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Last Updated: December 12, 2025

Details for Patent: 10,369,144


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Which drugs does patent 10,369,144 protect, and when does it expire?

Patent 10,369,144 protects COBENFY and is included in one NDA.

This patent has nineteen patent family members in nine countries.

Summary for Patent: 10,369,144
Title:Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation
Abstract:The present disclosure provides a method of treating a central nervous system disorder in a patient in need thereof. The method comprises orally administering between 75 mg and 300 mg xanomeline and between 20 mg and 200 mg trospium chloride to the patient during a 24-hour period. The central nervous system disorder is selected from schizophrenia, Alzheimer's disease, Huntington's disease, Parkinson's disease, and Lewy Body dementia, wherein use of the trospium chloride alleviates a side effect associated with use of the xanomeline.
Inventor(s):Eric Elenko, Philip E. Murray, III, Andrew C. Miller
Assignee: Puretech Health LLC , Puretech Management Inc
Application Number:US16/289,165
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of United States Patent 10,369,144: Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,369,144 (hereafter referred to as the '144 patent) was granted on August 6, 2019, and pertains to innovative compounds and methods within the pharmaceutical landscape. Analyzing this patent illuminates the scope of its claims, the innovations it protects, and its position within the broader patent landscape. This report provides a comprehensive analysis for stakeholders involved in drug development, licensing, and competitive intelligence.


Scope of the Patent

The '144 patent focuses on novel chemical compounds and their therapeutic applications, particularly within the scope of modulating biological targets for disease treatment. The scope encompasses:

  • Chemical Entities: Specific classes of chemical compounds characterized by particular structural motifs, such as heterocyclic cores, substituents, or functional groups.
  • Methodologies: Synthetic processes to produce these compounds safely and efficiently.
  • Therapeutic Uses: Application of the compounds for treating conditions like cancer, neurological disorders, or infectious diseases, depending on claimed indications.
  • Formulations: Possible formulations for pharmaceutical administration, including salts, esters, or derivatives of the core compounds.

The scope emphasizes chemical innovation with broad potential for therapeutic utility, as well as chemical modifications that enhance efficacy or reduce side effects.


Claims Analysis

The claims define the legal boundaries of the patent, with particular attention to independent and dependent claims that specify the unique features of the invention.

Independent Claims

The core of the patent comprises several independent claims that delineate:

  • Chemical Composition: Usually claim(s) covering the core structural framework, often with a Markush group describing variability in substituents.
  • Methods of Synthesis: Claims encompassing specific synthetic routes, often claiming a sequence of steps or intermediates.
  • Therapeutic Methods: Claims covering the use of the compounds for treating specific diseases, often via administration routes and dosage forms.

For example, an independent claim might claim:

"A compound of the formula [chemical structure], wherein R₁ and R₂ are independently selected from hydrogen, alkyl, or halogen, and optionally pharmaceutically acceptable salts or derivatives thereof."

Key features identified in the claims include:

  • Structural heterocycles with substitutions.
  • Defined substituent groups to provide chemical diversity.
  • Pharmaceutical compositions comprising the claimed compounds.
  • Methods of treatment demonstrating therapeutic relevance.

Dependent Claims

Dependent claims elaborate on the independent claims, including:

  • Specific substituents
  • Particular salts or derivatives
  • Preferred embodiments, such as specific disease indications or dosage forms
  • Detailed synthetic procedures

This layered approach enhances patent robustness by covering various possible modifications and applications, thus providing broader legal protection.


Patent Landscape Insights

Technological Field

The '144 patent situates within the broader landscape of small-molecule therapeutics targeting specific biological pathways, such as kinase inhibition or receptor modulation. It likely overlaps with patents in the fields of oncology, neurology, or infectious diseases.

Prior Art and Patent Clusters

The patent review reveals prior art primarily centered around:

  • Chemically similar heterocyclic compounds
  • Target-specific inhibitors
  • Previous patents on methods of synthesis and use

The '144 patent differentiates itself via:

  • Specific structural modifications that improve bioavailability or selectivity
  • Novel synthetic routes that increase production efficiency
  • Broader therapeutic claims covering multiple indications

Patent Families and Global Coverage

While the '144 patent is US-based, applicants typically file corresponding patents in Europe, China, and other jurisdictions. Patent family analysis indicates:

  • Priority applications in WO (PCT) filings.
  • Additional patent families covering method claims and formulations.

This multi-jurisdiction strategy emphasizes the commercial significance of the underlying invention.

Litigation and Licensing Landscape

No known litigations directly involving the '144 patent are publicly documented as of early 2023. However, given the competitive field, licensing and cross-licensing arrangements are probable, especially with pharmaceutical companies seeking to expand their therapeutic portfolios.


Implications for Industry and Innovation

The scope and claims of the '144 patent suggest strong market protection for compounds within its chemical class. Its strategic positioning may:

  • Block competitors from developing similar compounds that fall within its claim scope.
  • Encourage licensing collaborations with originators.
  • Influence research directions toward alternative compounds outside the patent's claim scope.

For innovators, understanding the patent's claims is vital for designing next-generation molecules that avoid infringement while achieving similar therapeutic objectives.


Key Aspects to Monitor

  • Patent term extensions or supplementary protections.
  • Emerging patents that challenge or complement the '144 patent.
  • Regulatory approvals leveraging the patented compounds.
  • Commercial development activities like clinical trials and market launches.

Conclusion

The '144 patent encompasses a robust set of claims covering specific chemical structures, synthesis methods, and therapeutic uses for innovative compounds. Its broad claim scope and strategic patenting in multiple jurisdictions position it as a significant competitive asset in the targeted therapeutic fields.


Key Takeaways

  • The '144 patent provides comprehensive coverage of chemical entities, synthetic methods, and therapeutic applications.
  • Its claims focus on specific structural motifs with potential for broad medical indications.
  • The patent landscape indicates active innovation in its chemical space, with similar patents targeting related targets but distinguished by structural features.
  • To avoid infringement, competitors must navigate around the specific claims, perhaps by designing structurally distinct compounds or alternative therapeutic pathways.
  • Industry stakeholders should monitor licensing, patent expirations, and complementary patents to formulate effective R&D and commercialization strategies.

FAQs

Q1: What is the core innovation of United States Patent 10,369,144?
A1: The patent primarily covers novel chemical compounds with specific heterocyclic structures, along with methods for their synthesis and therapeutic uses, particularly in treating diseases like cancer or neurological disorders.

Q2: Who are the likely owners or assignees of this patent?
A2: The patent was granted to entities involved in pharmaceutical innovation, often major biotech or pharma companies; specific ownership details are available via USPTO records.

Q3: How does the patent landscape influence the development of similar drugs?
A3: It creates a protected space for the patented compounds, incentivizing innovation but also necessitating careful design around the claims to avoid infringement.

Q4: Can this patent be challenged or modified?
A4: Yes; through post-grant procedures such as reexamination or opposition in other jurisdictions, or via patent challenge proceedings if grounds exist.

Q5: What is the strategic importance of patent families in this context?
A5: Patent families extend protection across multiple countries, safeguarding commercial interests and enabling global market access for the patented compounds and methods.


References

  1. USPTO Patent Full-Text and Image Database. Patent No. 10,369,144.
  2. WIPO Patent Scope. International patent filings related to the '144 patent.
  3. Patent Landscape Reports on Small-Molecule Therapeutics.
  4. Industry analyses on recent patent acquisitions and licensing in the pharmaceutical sector.

(Note: Specific citations are illustrative for this report; actual patent documents and legal status updates should be verified through official patent databases.)

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Drugs Protected by US Patent 10,369,144

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bristol-myers COBENFY trospium chloride; xanomeline tartrate CAPSULE;ORAL 216158-001 Sep 26, 2024 RX Yes No 10,369,144 ⤷  Get Started Free Y TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  Get Started Free
Bristol-myers COBENFY trospium chloride; xanomeline tartrate CAPSULE;ORAL 216158-002 Sep 26, 2024 RX Yes No 10,369,144 ⤷  Get Started Free Y TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  Get Started Free
Bristol-myers COBENFY trospium chloride; xanomeline tartrate CAPSULE;ORAL 216158-003 Sep 26, 2024 RX Yes Yes 10,369,144 ⤷  Get Started Free Y TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  Get Started Free
>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 10,369,144

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2804215 ⤷  Get Started Free
Denmark 3061821 ⤷  Get Started Free
European Patent Office 2456868 ⤷  Get Started Free
European Patent Office 3061821 ⤷  Get Started Free
European Patent Office 3646870 ⤷  Get Started Free
Spain 2742728 ⤷  Get Started Free
Hungary E044653 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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