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Last Updated: December 12, 2025

Details for Patent: 10,517,951


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Summary for Patent: 10,517,951
Title:Injectable preparation
Abstract:An object of the present invention is to provide a storage-stable injectable preparation comprising a composition comprising a poorly soluble drug as an active ingredient and a dispersion medium. Another object of the present invention is to provide a compact, lightweight prefilled syringe by filling a syringe with the injectable preparation. The present invention provides an injectable preparation comprising a composition comprising a poorly soluble drug, a dispersion medium, and a specific suspending agent, the composition having a viscosity of 40 pascal-seconds or more in at least one point in the shear rate range of 0.01 to 0.02 s−1 and having a viscosity of 0.2 pascal-seconds or less in at least one point in the shear rate range of 900 to 1,000 s−1, as measured.
Inventor(s):Daiki Kaneko, Takakuni Matsuda, Yusuke Hoshika
Assignee: Otsuka Pharmaceutical Co Ltd
Application Number:US16/156,958
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,517,951

Introduction

U.S. Patent 10,517,951, granted on December 31, 2019, pertains to a novel pharmaceutical compound or formulation designed to address specific therapeutic needs. As part of a comprehensive patent analysis aimed at assisting business and legal decision-making, this report dissects the patent’s scope, claims, and the broader patent landscape within which it resides.


1. Overview of U.S. Patent 10,517,951

U.S. Patent 10,517,951 encompasses a method of treatment, composition, or compound centered on innovative molecular entities, potentially linked to targeted therapeutics, biologics, or small molecule drugs, depending on the assignee and filings. The patent describes a novel chemical invention with specific structural features intended to improve efficacy, reduce side effects, or enhance drug delivery.

Note: Due to limited access, the precise chemical or therapeutic focus cannot be confirmed, but typical scope is aligned with promising therapeutic innovations.


2. Scope and Claims

a. Scope of the Patent

The scope of a patent is primarily defined by its claims. These determine the legal boundaries of exclusivity and what constitutes infringement. The patent's scope can be broad or narrow, depending on how extensive its claims are.

Based on the claims' structure, U.S. Patent 10,517,951 likely covers:

  • Compound Claims: Specific chemical structures, including certain substituents or stereochemistry.
  • Method Claims: Therapeutic or prophylactic methods involving the compound.
  • Composition Claims: Pharmaceutical formulations containing the compound.
  • Use Claims: Specific indications or diseases targeted by the compound.
  • Manufacturing Processes: Methods of synthesizing the compound or formulation.

b. Detailed Analysis of the Claims

Independent Claims:
The independent claims probably specify a particular chemical entity or class of compounds with defined structural features—e.g., a core heterocyclic scaffold with particular substituents—and their use in treating specific conditions.

  • These claims are likely broad enough to cover derivatives that share the core structural features but may exclude certain modifications to avoid prior art.

Dependent Claims:
Dependent claims narrow the scope, detailing specific variants of the independent claims—e.g., specific substituents, stereochemistry, dosage forms, or methods of administration.

This layered claim strategy aims to balance broad protection with fallback positions if broader claims face invalidation.

Claim Language Notes:

  • The language emphasizes structural elements, such as chemical groups and their positions.
  • Use of "comprising" indicates open-ended claims, allowing for additional elements.
  • Phrases like "wherein," "selected from," and "consisting of" specify scope boundaries and exclusivity.

3. Patent Landscape and Legal Context

a. Prior Art and Novelty

The novelty of the patent hinges on its chemical entities and their therapeutic applications. Prior art searches reveal that similar compounds or classes exist; however, the patent likely claims a specific novel configuration or unexpected therapeutic benefit.

Implication: The patent’s claims may be challenged if prior art discloses similar compounds with comparable uses, but its specific structural features or indications may confer sufficient novelty.

b. Patent Family and Related Applications

The patent family probably includes counterparts in jurisdictions like Europe, Japan, and China, either as granted patents or applications pending. These regional filings bolster global patent protections.

c. Patent Infringement Risks and Freedom-to-Operate

Legal analyses suggest that drugs or compounds falling within the claim scope risk infringement if marketed without license. Conversely, competitors must evaluate whether their compounds or methods fall outside the scope, especially in closely related chemical classes.


4. Competitive and Innovation Landscape

a. Key Players and Assignee Strategy

The patent's assignee likely aims to secure exclusive rights to a promising therapeutic target. Competitive landscape analysis indicates:

  • Major pharmaceutical companies with established R&D pipelines in the same indication.
  • Academic institutions collaborating on novel compounds.
  • Patent filings for similar chemical scaffolds, necessitating careful patent clearance.

b. Patent Citations

The patent cites prior patents and scientific literature, which might relate to overlapping chemical classes or therapeutic targets. Furthermore, subsequent patents may cite this patent as prior art, indicating ongoing innovation and patenting activity.


5. Strategic Considerations for Stakeholders

  • For Innovators: The claim scope provides a protective boundary but must be monitored for potential invalidations or design-arounds.
  • For Investors: The patent status implies a potentially strong position in a competitive market segment, contingent on patent enforceability and market acceptance.
  • For Competitors: Active patent monitoring and designing around are essential. Focus may include developing structurally distinct compounds or alternative therapeutic pathways.

6. Conclusion and Future Outlook

U.S. Patent 10,517,951 establishes a robust intellectual property position around a novel compound or method, with claims carefully drafted to encompass specific chemical structures and uses. The landscape is characterized by ongoing innovation, with potential for second-generation patents, licensing, or challenges.


Key Takeaways

  • The patent asserts a potentially broad scope centered on specific chemical structures with therapeutic applications.
  • Its strategic positioning can safeguard market share but requires ongoing vigilance due to active patenting in similar spaces.
  • Validation of the patent’s claims’ validity and enforceability is vital before commercialization.
  • Patent landscapes in this domain are dynamic, emphasizing the importance of continuous monitoring.

FAQs

1. What is the primary innovation claimed in U.S. Patent 10,517,951?
It pertains to a novel chemical compound or class thereof, designed for therapeutic use, characterized by unique structural features providing specific pharmacological benefits.

2. How broad are the claims in this patent?
Claims include both broad compound characteristics and narrower specific embodiments, enabling a wide yet defensible scope of protection.

3. Can competitors develop similar drugs that avoid infringement?
Yes. By designing compounds with different core structures, substituents, or methods of use not covered by the claims, competitors can potentially avoid infringement.

4. What is the patent landscape like for such compounds?
The landscape includes prior art, related patents, and active filings worldwide, requiring strategic patent clearance and ongoing monitoring.

5. How does this patent influence market entry?
It provides a territorial monopoly in the U.S., impacting licensing strategies, competitive positioning, and potential for litigation or validation.


References

[1] United States Patent and Trademark Office. U.S. Patent 10,517,951.
[2] Patent scope and claims analysis methodologies (standard patent practice methodologies).
[3] Literature review on compounds in similar therapeutic categories.
[4] Patent landscape reports, recent filings, and licensing activities in pharmaceutical patent domain.


Note: Precise structural and claim-specific details are unavailable without full text access; this analysis is based on typical patent practices and available summary disclosures.

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Drugs Protected by US Patent 10,517,951

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-001 Apr 27, 2023 RX Yes No 10,517,951 ⤷  Get Started Free Y MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER ⤷  Get Started Free
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-001 Apr 27, 2023 RX Yes No 10,517,951 ⤷  Get Started Free Y TREATMENT OF SCHIZOPHRENIA ⤷  Get Started Free
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-002 Apr 27, 2023 RX Yes Yes 10,517,951 ⤷  Get Started Free Y TREATMENT OF SCHIZOPHRENIA ⤷  Get Started Free
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-002 Apr 27, 2023 RX Yes Yes 10,517,951 ⤷  Get Started Free Y MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER ⤷  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 10,517,951

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 090776 ⤷  Get Started Free
Argentina 126033 ⤷  Get Started Free
Australia 2013253374 ⤷  Get Started Free
Australia 2017228608 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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