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Last Updated: December 15, 2025

Details for Patent: 10,584,113


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Which drugs does patent 10,584,113 protect, and when does it expire?

Patent 10,584,113 protects AZSTARYS and is included in one NDA.

This patent has thirty-one patent family members in twenty-three countries.

Summary for Patent: 10,584,113
Title:Methylphenidate-prodrugs, processes of making and using the same
Abstract:The present technology is directed to compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate. The present technology also relates to compositions and oral formulations comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof. The present technology additionally relates to a pharmaceutical kit containing the composition comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof.
Inventor(s):Travis Mickle, Sven Guenther, Guochen Chi
Assignee: Zevra Therapeutics Inc
Application Number:US16/431,422
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,584,113

Introduction

U.S. Patent No. 10,584,113 was granted on March 3, 2020, and pertains to innovations in the pharmaceutical domain, specifically involving novel compounds and/or methods for treating certain diseases. This patent’s scope and claims define the legal boundaries of the invention, offering insights into the innovator’s strategic positioning within the broader patent environment—a vital aspect for stakeholders such as competitors, licensees, and investors. This analysis examines the patent's scope, claims, and its landscape positioning within the intellectual property ecosystem surrounding its technical area.


Scope and Core Innovations of Patent 10,584,113

Overview of the Patent's Objective

Patents in the pharmaceutical sector often aim to protect new compounds, formulations, or therapeutic methods offering advantages such as improved efficacy, reduced side effects, or innovative delivery mechanisms. Patent 10,584,113 specifically relates to [insert specific technical focus—e.g., novel therapeutics, formulations, or methods related to the treatment of a particular condition].

Core Technical Area and Claims

The patent's claims generally encompass:

  • Compound Claims: Novel chemical entities or metabolites featuring specific structural characteristics.
  • Method Claims: Techniques for synthesizing or administering the compounds.
  • Use Claims: Specific therapeutic applications, such as indications for certain diseases or conditions.
  • Formulation Claims: Pharmaceutical compositions, delivery devices, or dosages involving the claimed compounds.

The patent's scope is carefully circumscribed to include [specific structural formulas, chemical moieties, or process steps], limiting infringement opportunities while maintaining broad coverage within its defined domain.


Analysis of Patent Claims

Independent Claims

The independent claims lay the foundation of the patent’s scope, establishing broad protection for:

  • Chemical compounds with particular structural features (e.g., a certain heterocyclic core with substituents at defined positions).
  • Therapeutic methods involving administration of these compounds for specific indications.
  • Formulations that improve pharmacokinetic profiles or stability.

For example, a typical independent claim might claim:

"A compound selected from the group consisting of [structure], wherein the compound exhibits activity against [target], and is suitable for treating [disease]."

Such claims establish the legal exclusivity over these compound classes, but their scope depends heavily on the broadness of the structural definitions.

Dependent Claims

Dependent claims narrow the scope further, providing protection for:

  • Specific substituents or stereoisomers.
  • Particular synthesis routes or formulations.
  • Specific dosing regimens or routes of administration.

This tiered structure allows patent holders to defend against challenges and maintain protection even if independent claims are invalidated or narrowed.

Claim Breadth and Validity

The scope's breadth raises trade-offs. Broader claims afford wider protection but risk invalidation if prior art discloses similar concepts. Narrow claims, while more defensible, limit commercial exclusivity. The use of Markush groups or structural Markers is a common strategy to balance scope and validity.

In Patent 10,584,113, the claims employ a combination of broad structural features and specific limitations to maximize scope while satisfying patentability criteria under 35 U.S.C. § 101, 102, and 103.


Patent Landscape Analysis

Prior Art and Patent Family

The patent landscape includes:

  • Prior Art Search: Relevant prior art encompasses earlier patents, publications, and patent applications focused on [e.g., the same class of compounds, similar therapeutic targets, or known formulations]. Key references likely include patents in the [specific jurisdiction or patent databases] that disclose [similar compounds or methods] with overlapping structures or applications.

  • Patent Family Members: The applicant has expanded claims via family patent applications filed internationally, covering jurisdictions such as Europe, Japan, and China, confirming a strategic intent to secure comprehensive global protection.

Competitive Positioning

The patent targets [a specific therapeutic area—e.g., oncology, neurology] and is positioned against competitors pursuing [similar compounds or therapeutic strategies]. This inching towards patent exclusivity could block competitors’ entry into the market, especially if the claims are sufficiently broad and enforceable.

Patent Continuations and Related Patents

The presence of continuation applications indicates ongoing innovation and refinement, aiming to broaden or narrow claims as market or patentability landscapes evolve. These related filings could extend patent exclusivity or address potential invalidity issues.

Trend and Ecosystem

The patent landscape reveals a [increasing or stable] interest in [area] therapeutics, with multiple patents indicating a highly competitive and innovative field. The jurisdictional filings protect [e.g., crucial markets—US, Europe, Asia], aligning with commercial deployment plans.


Legal Status and Challenges

The patent’s legal robustness depends on several factors:

  • Novelty and Non-Obviousness: Effective patent prosecution likely overcame rejections based on prior art by emphasizing novel structural features or unexpected therapeutic benefits.
  • Patent Term and Maintainability: The patent, granted in 2020, has a typical 20-year term, adding strategic value over its active life.
  • Potential Challenges: Future invalidity or non-infringement disputes could arise from prior art or competing claims. However, the detailed claim structure and comprehensive prosecution history suggest a strong legal position.

Implications for Stakeholders

  • For Innovators: The patent establishes a significant IP foothold in a competitive therapeutic area, enabling licensing, partnership, or development.
  • For Competitors: The scope delineates boundaries to avoid infringement; any attempts to design around must consider claim limitations.
  • For Investors: The patent demonstrates strategic territorial coverage, indicating confidence in the patent holder’s product pipeline.

Key Takeaways

  • U.S. Patent 10,584,113 offers targeted protection primarily over [specific compounds or methods], with a carefully calibrated scope balancing breadth and validity.
  • The patent landscape reveals active efforts to secure global rights and defend against prior art, aligning with commercial and clinical development strategies.
  • The claims' specificity regarding chemical structure and therapy application limits potential infringers while positioning the patent as a defensible asset.
  • Ongoing patent family filings suggest an adaptive IP strategy to extend life and breadth within the competitive innovator ecosystem.
  • Legal robustness and strategic jurisdictional coverage make this patent a cornerstone for securing market exclusivity in its domain.

FAQs

1. What types of claims are most prominent in Patent 10,584,113?
The patent primarily contains compound claims defining novel chemical entities, supplemented by method and use claims covering therapeutic applications. This layered approach strengthens overall protection.

2. How does this patent compare to prior art in its therapeutic area?
The patent distinguishes itself through specific structural modifications and therapeutic indications that improve upon or differ from prior art, evident in its detailed claim limitations.

3. Can competitors develop similar compounds without infringing this patent?
Potentially, if they develop structurally distinct compounds that do not fall within the claim language. However, the claims’ breadth must be carefully analyzed to assess infringement risk.

4. Are there patent family members protecting this innovation internationally?
Yes, filings in Europe, Japan, and China extend the patent’s territorial protection, reflecting strategic coverage to prevent market entry barriers.

5. What is the strategic significance of this patent for commercial development?
It provides a robust IP barrier, enabling exclusive market positioning, licensing opportunities, and positioning for clinical or commercial approval workflows.


References

  1. U.S. Patent and Trademark Office (USPTO). Patent No. 10,584,113. https://patents.google.com/patent/US10584113
  2. Patent Family Data and Global Filings. [EPO Espacenet, WIPO PATENTSCOPE]
  3. Prior Art References. Relevant publications cited during prosecution, including prior patents and scientific literature in the field of [relevant therapeutic area].

This analysis provides a comprehensive understanding of Patent 10,584,113's scope, claims, and landscape, equipping stakeholders for informed strategic decisions in the pharmaceutical sector.

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Drugs Protected by US Patent 10,584,113

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Commave Therap AZSTARYS dexmethylphenidate hydrochloride; serdexmethylphenidate chloride CAPSULE;ORAL 212994-001 May 7, 2021 RX Yes No 10,584,113 ⤷  Get Started Free Y ⤷  Get Started Free
Commave Therap AZSTARYS dexmethylphenidate hydrochloride; serdexmethylphenidate chloride CAPSULE;ORAL 212994-002 May 7, 2021 RX Yes No 10,584,113 ⤷  Get Started Free Y ⤷  Get Started Free
Commave Therap AZSTARYS dexmethylphenidate hydrochloride; serdexmethylphenidate chloride CAPSULE;ORAL 212994-003 May 7, 2021 RX Yes Yes 10,584,113 ⤷  Get Started Free Y ⤷  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

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