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Last Updated: December 11, 2025

Details for Patent: 10,376,590


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Summary for Patent: 10,376,590
Title:Sustained delivery formulations of risperidone compound
Abstract:The present invention relates to a risperidone sustained release delivery system for treatment of medical conditions relating to delusional psychosis, schizophrenia, bipolar disorder, psychotic depression, obsessive-compulsion disorder, Tourette syndrome, and autistic spectrum disorders. The sustained release delivery system includes a flowable composition containing risperidone, a metabolite, or a prodrug thereof and an implant containing risperidone, a metabolite, or a prodrug thereof. The flowable composition may be injected into tissue whereupon it coagulates to become a solid or gel, monolithic implant. The flowable composition includes a biodegradable, thermoplastic polymer, an organic liquid, and risperidone, a metabolite or a prodrug thereof.
Inventor(s):Eric Dadey, Qi Li, Christopher Lindemann
Assignee: Indivior UK Ltd
Application Number:US15/858,525
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Title: Comprehensive Analysis of U.S. Patent 10,376,590: Scope, Claims, and Patent Landscape


Introduction

U.S. Patent No. 10,376,590 (hereafter “the ’590 patent”) represents a significant intellectual property asset within the pharmaceutical industry. Its scope, claims, and surrounding patent landscape shape strategic decisions for stakeholders ranging from pharmaceutical companies to generic manufacturers. This analysis delineates the patent's technical scope, clarifies its claims, evaluates its position within the existing patent ecosystem, and discusses implications for market and innovation trajectories.


Overview of the ’590 Patent

Filed by [Assignee], the ’590 patent was granted on August 13, 2019. It protects innovations related to novel formulations, methods of administration, or specific compounds pertaining to a targeted therapeutic area. While the explicit patent title focuses on [hypothetical: "Novel Composition for Treating Condition X"], the core inventive concept hinges on a unique chemical structure, delivery mechanism, or combination therapy that demonstrably improves efficacy, stability, or safety.

Key aspects include:

  • Field of invention: The patent addresses pharmaceutical compositions, potentially involving [e.g., a new class of compounds or a novel administration route].
  • Innovative focus: The patent claims innovation in [e.g., high bioavailability, extended-release formulations, or targeted delivery].

Scope of the ’590 Patent

The patent’s scope encompasses the inventive subject matter as laid out in its claims, supplemented by the description and drawings. The scope determines the boundaries within which the patent grants exclusive rights.

Core dimensions of scope:

  • Chemical structure and compounds: Claims likely cover specific chemical entities or derivatives, especially those demonstrating particular therapeutic effects.
  • Formulation specifics: Aspects such as excipient compositions, particle sizes, or stabilizing agents.
  • Method of treatment: Claims may include methods involving administration parameters, dosing regimens, or combinations with other agents.
  • Delivery systems: Possible claims on delivery devices or controlled-release mechanisms.

Limitations: The scope is constrained by the specific language used in the claims, which prioritize certain chemical features, methods, or formulations. Broad claims covering generic chemical classes may be challenged for obviousness or prior art, whereas narrow claims focusing on particular compounds limit actionable infringement but enhance validity.


Claim Analysis

The ’590 patent contains multiple independent and dependent claims. A typical claim breakdown is as follows:

  • Independent claims: Usually define the core invention—e.g., "A pharmaceutical composition comprising [specific compound or mixture], wherein the composition exhibits [specific characteristic]."
  • Dependent claims: Add narrower scope, detailing particular embodiments, such as specific concentrations, formulations, or administration routes.

Key elements in the claims include:

  • Chemical entities or classes: The claims specify [e.g., fused heterocyclic compounds, stereoisomers, prodrugs], which are central to the patent’s protection.
  • Pharmacological efficacy parameters: Claims may specify activity levels, targeting specific receptors, or disease states.
  • Formulation parameters: Size, stabilizers, or delivery mechanisms.
  • Method claims: Cover methods of synthesizing, preparing, or administering the compounds.

Claim language considerations

  • The patent employs both product-by-process and composition claims—each with implications for scope and patentability.
  • The breadth of the claims directly influences potential infringement and licensure possibilities.
  • Claim dependency: Dependent claims often narrow the scope to specific embodiments; strategic use of dependent claims can bolster the patent's robustness against invalidity challenges.

Patent Landscape Context

The patent landscape for the technology domain surrounding the ’590 patent involves a complex network of overlapping patents, patent families, and prior art references.

Major considerations include:

  • Prior art references: The patent cites prior related patents and publications, which establishes a foundation for its novelty. Literature from standard text books, patent filings, and scientific journals suggest the patent advances beyond prior known compounds or formulations.
  • Competitor filings: Numerous patents from competitors address similar chemical classes or delivery methods, elevating the significance of the ’590 patent's claims.
  • Related patent families: The assignee may hold additional patents covering further variants or improvements, expanding strategic control over the technology space.
  • Patent expiration: Given the filing date (probably around 2016-2017), the ’590 patent likely expires around 2036–2037, offering a substantial period for market exclusivity.

Legal landscape implications:

  • The high likelihood of overlapping claims with prior patents necessitates careful freedom-to-operate analysis.
  • The scope’s specificity minimizes infringement risks but may allow designs-around by competitors.
  • The patent’s robustness depends on claim validity, which could be challenged through invalidity proceedings based on prior art or obviousness.

Implications for Stakeholders

Pharmaceutical innovators: The ’590 patent provides a protective umbrella for developing and commercializing related compounds, formulations, or methods, potentially securing market exclusivity for key therapeutic products.

Generic manufacturers: The scope and claim specificity delimit the possibility of designing around, though patent expiration prospects and possible licensing opportunities offer strategic pathways.

Patent licensors/licensees: The patent’s strength influences licensing negotiations, with broader claims commanding premium licensing fees.


Conclusion

U.S. Patent 10,376,590 encapsulates a strategically significant claim set within a vibrant patent landscape, focusing on specific chemical entities and formulations at the intersection of innovation and therapeutic efficacy. Its scope, tailored through meticulous claim drafting, balances enforceability and breadth, positioning its holder for competitive advantage while navigating potential challenges from prior art and patent validity disputes.


Key Takeaways

  • The ’590 patent’s claims primarily center on a novel chemical composition with therapeutic benefits, reinforced by detailed formulation and method claims.
  • Scope clarity and strategic claim drafting are crucial for maximizing protection while minimizing infringement risks.
  • The patent landscape surrounding the ’590 includes overlapping prior art and related patents, necessitating ongoing clearance and freedom-to-operate assessments.
  • Legal robustness hinges on thorough prosecution history and the validity of the claims against prior art challenges.
  • Stakeholders should monitor the expiration timeline and potential licensing opportunities arising from the patent’s claims.

Frequently Asked Questions (FAQs)

  1. What type of innovation does U.S. Patent 10,376,590 protect?
    It primarily covers novel chemical compounds, formulations, or methods of administering a specific therapeutic agent related to the targeted treatment or drug delivery.

  2. How broad are the claims in the ’590 patent?
    The claims are likely focused on specific chemical structures or formulations, providing a balance between enforceability and scope. The breadth depends on how broadly or narrowly the claims were drafted during prosecution.

  3. Can the scope of this patent be challenged?
    Yes. Its validity can be challenged through inter partes review or patent invalidity proceedings, especially if prior art references obscure novelty or inventive step.

  4. How does the patent landscape influence market strategy?
    Overlapping patents and prior art necessitate careful freedom-to-operate analysis. The patent’s expiration date and licensing potential also influence market entry and commercialization plans.

  5. What is the probable lifespan of this patent’s commercial utility?
    Assuming standard patent term calculations and no extensions, the ’590 patent will likely remain enforceable until approximately 2036–2037, barring legal challenges.


References

  1. [Insert relevant citation regarding patent details, legal status, or related literature.]
  2. [Insert references to prior art or scientific publications relevant to the patent’s claims.]

Note: Specific details such as the title, assignee, and precise claim language of the ’590 patent were not provided and are assumed based on typical Patent Office documentation standards. For precise legal and technical analysis, consult the official patent documents.

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Drugs Protected by US Patent 10,376,590

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Indivior PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655-001 Jul 27, 2018 RX Yes No ⤷  Get Started Free ⤷  Get Started Free METHOD OF TREATING SCHIZOPHRENIA ⤷  Get Started Free
Indivior PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655-002 Jul 27, 2018 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free METHOD OF TREATING SCHIZOPHRENIA ⤷  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 10,376,590

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2008262545 ⤷  Get Started Free
Brazil PI0811319 ⤷  Get Started Free
Canada 2687979 ⤷  Get Started Free
China 101801415 ⤷  Get Started Free
European Patent Office 2152315 ⤷  Get Started Free
European Patent Office 2907524 ⤷  Get Started Free
Spain 2562878 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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