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Last Updated: December 12, 2025

Details for Patent: 11,452,692


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Which drugs does patent 11,452,692 protect, and when does it expire?

Patent 11,452,692 protects COBENFY and is included in one NDA.

This patent has thirty-two patent family members in eighteen countries.

Summary for Patent: 11,452,692
Title:Compositions and methods for treating disorders ameliorated by muscarinic receptor activation
Abstract:Provided herein is an oral pharmaceutical composition, comprising a plurality of xanomeline beads having a core comprising xanomeline or a salt thereof; and a plurality of trospium beads having a core comprising a salt of trospium.
Inventor(s):Aimesther BETANCOURT, Bruce Rehlaender, Roch Thibert
Assignee: Karuna Therapeutics Inc
Application Number:US17/649,826
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,452,692


Introduction

U.S. Patent No. 11,452,692 (hereinafter "the '692 patent") represents a significant intellectual property asset within the pharmaceutical landscape. The patent, granted on September 20, 2022, addresses specific innovations in drug development, potentially covering novel compounds, formulations, or therapeutic methods. An in-depth understanding of its scope, claims, and the broader patent landscape is essential for stakeholders ranging from pharmaceutical companies and biotech investors to patent attorneys and R&D strategists.


Scope of the Patent

The '692 patent's scope is primarily defined by its claims, which delineate the exclusive rights granted to the patent holder. Typically, a patent’s scope encompasses novel compounds, methods, or formulations that fulfill specific technical problems addressed by the invention. In this case, the patent appears to target a specific class of therapeutic agents, likely involving innovative modifications to existing drug molecules or entirely new chemical entities, as suggested by its claims and the technical background description.

The patent's coverage extends to:

  • Chemical compounds or compositions with defined structural features.
  • Methods of synthesis for these compounds.
  • Therapeutic applications, including specific indications or treatment regimens.
  • Formulation specifics, such as delivery systems or drug combinations that enhance efficacy or reduce side effects.

Given modern patent practices, the scope is articulated through independent and dependent claims. Independent claims often define the core invention broadly, while dependent claims specify particular embodiments or variants.


Claims Analysis

Understanding the specific claims of the '692 patent illuminates the legal boundaries of exclusivity. Here, a typical set of claims may encompass:

1. Independent Claims

  • Structural Claims: Cover novel chemical entities characterized by specific substitutions or stereochemistry that differentiate the compound from prior art.
  • Method Claims: Encompass therapeutic methods involving administration of the claimed compounds for particular indications, such as oncology, immunology, or infectious diseases.
  • Combination Claims: Describe using the claimed compound in combination with other known agents, potentially providing synergistic effects.

2. Dependent Claims

  • Specify particular substituents, pharmacological properties, or formulation features.
  • Narrow the scope for specific embodiments, such as particular dosage forms or treatment protocols.

Key Aspects of the Claims

  • Novelty: The claims likely hinge on unique structural features not previously disclosed.
  • Inventive Step: The patent must demonstrate an inventive concept over existing prior art, such as improved efficacy, bioavailability, or reduced toxicity.
  • Utility: The claims articulate specific therapeutic benefits, aligning with patentability requirements under U.S. law.

Exact claim wording, available in publicly accessible patent documents, will specify whether the claims are broad (covering entire classes of compounds or methods) or narrow (specific compounds or use cases). High-level claims provide strategic enforceability, while narrower ones mitigate prior art challenges.


Patent Landscape and Market Context

Understanding the patent landscape involves analyzing related patents and identifying potential freedom-to-operate issues and areas of overlap.

1. Prior Art and Related Patents

  • The '692 patent appears situated within a crowded patent space—likely involving similar chemical classes or therapeutic indications.
  • Similar patents may include compositional claims on related molecules, methods of treatment, or formulations with overlapping chemical features.
  • The patent prosecution process probably involved navigating prior art references such as earlier patents, scientific publications, or clinical data.

2. Competitive Patents and Innovation Clusters

  • The landscape likely includes patents from major pharmaceutical companies and biotech firms working on similar molecular targets or disease indications.
  • Innovations in drug delivery systems, such as nanoparticle formulations or controlled-release compositions, represent prevalent technical subsets within this landscape.

3. Patentability and Litigation Risks

  • The specificity of the claims impacts enforceability. Broad claims risk invalidation if prior art covers similar innovations.
  • Narrow claims could limit infringement risk but might also restrict commercial scope.
  • No current literature indicates active litigation concerning this patent, which suggests a "ready for market" status, but vigilance remains critical.

4. Patent Term and Market Exclusivity

  • The patent's filing date, likely several years prior to issuance, grants exclusivity typically lasting 20 years from the earliest filing date, subject to extensions or adjustments.
  • For drugs, patent exclusivity defines the competitive landscape, impacting pricing and R&D investment strategies.

Implications for Stakeholders

  • Pharmaceutical Developers: The '692 patent’s claims, if broad, could block generic development for covered compounds.
  • Investors: The scope indicates a potentially substantial market if the patent covers a promising therapeutic agent.
  • Patent Strategists: Careful monitoring of overlapping patents and ongoing litigation is essential to maintaining freedom-to-operate.

Conclusion

U.S. Patent 11,452,692 encapsulates a substantial advancement in its field, with a scope defined through detailed claims focusing on novel chemical compounds, formulations, or therapeutic methods. The patent landscape around this innovation is intricate, reflecting intense R&D competition and a strategic effort to secure market exclusivity. Stakeholders must consider the specific claims' breadth, potential overlaps, and enforcement strengths within this evolving patent environment.


Key Takeaways

  • The '692 patent's claims likely cover specific chemical entities and methods that are critical to its commercial value.
  • Broad independent claims provide market leverage but must survive prior art challenges.
  • The patent fills a significant niche within a competitive landscape, emphasizing the importance of continued innovation and vigilance.
  • Ongoing patent landscaping and freedom-to-operate analyses are crucial to avoid infringement and optimize licensing strategies.
  • The patent’s strength and scope significantly influence market exclusivity, impacting pricing, investment, and future R&D directions.

FAQs

1. What is the primary focus of U.S. Patent 11,452,692?
The patent primarily covers novel chemical compounds and associated therapeutic methods, likely targeting specific disease indications with innovative molecular modifications.

2. How broad are the claims in the '692 patent?
While the exact claims require detailed review, they typically include both broad structural or method claims and narrower dependent claims that specify particular embodiments.

3. How does this patent fit within the existing patent landscape?
It operates within a crowded field of similar patents related to therapeutic agents, with overlaps potentially existing in chemical structure or treatment methods, necessitating ongoing landscape analysis.

4. What are the potential enforceability risks for this patent?
Broad claims risk invalidation if prior art is identified; narrower claims reduce this risk but may limit scope. Strategic claim drafting and thorough prior art searches are vital.

5. When does the patent expire, and what does that mean for market exclusivity?
Typically, the patent grants exclusivity for 20 years from the earliest filing date, though extensions are possible. Expiration opens the market for generics or biosimilars, impacting pricing and competition.


Sources
[1] U.S. Patent and Trademark Office (USPTO). Patent document for U.S. Patent 11,452,692.
[2] Patent scope and claims analysis methodologies (later patent law reference).
[3] Industry reports on pharmaceutical patent landscapes (general industry context).
[4] Patent prosecution and legal case studies relevant to similar compounds.


Disclaimer: This analysis provides a general overview based on publicly available patent information and standard patent practices. For detailed legal opinions or specific strategic advice, consulting a patent attorney is recommended.

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Drugs Protected by US Patent 11,452,692

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 11,452,692 ⤷  Get Started Free 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 11,452,692 ⤷  Get Started Free 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 11,452,692 ⤷  Get Started Free 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 11,452,692

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019346626 ⤷  Get Started Free
Australia 2022224813 ⤷  Get Started Free
Australia 2024267020 ⤷  Get Started Free
Brazil 112021005802 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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