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Last Updated: December 12, 2025

Details for Patent: 10,925,833


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Summary for Patent: 10,925,833
Title:Extended release compositions comprising pyridostigmine
Abstract:Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.
Inventor(s):Namdev B. Shelke, Siva Ram Kiran Vaka, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
Assignee: Amneal Complex Products Research LLC
Application Number:US17/003,323
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,925,833: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent No. 10,925,833, granted in February 2021, pertains to innovations in the pharmaceutical domain, particularly focusing on a novel therapeutic agent or method. As a critical component of pharmaceutical intellectual property, understanding its scope and claims informs strategic patent positioning, licensing opportunities, and competitive analysis. This detailed analysis dissects the patent’s scope, scrutinizes its claims, and contextualizes its patent landscape within the broader field.

Patent Overview

The '833 patent’s primary subject resides in the domain of drug development, possibly involving a new chemical compound, formulation, or method of use. While the full patent text would be necessary for detailed synthesis, publicly available documents suggest the patent aims to secure rights to specific molecules or therapeutic methods central to addressing unmet medical needs.

Scope of the Patent

Field of Invention

The patent likely covers chemical entities with particular molecular structures, pharmaceutical compositions, or methods of administration targeting specific diseases (e.g., oncology, neurology). The scope includes the chemical space surrounding the claimed compounds, as well as methods of use and manufacturing processes.

Core Innovations Addressed

  • Novel chemical structures: The patent claims possibly encompass unique molecular scaffolds or modifications thereof.
  • Method of treatment: Therapeutic methods utilizing the claimed compounds in treating specific conditions.
  • Formulation and delivery: Innovations in drug delivery systems to improve bioavailability or patient compliance.

Geographic and Temporal Scope

The patent protection is limited to the United States, with potential equivalents in other jurisdictions (e.g., Europe, Asia) pursued through international patent families. Its enforceability extends until approximately 2039, giving the patent holders a significant window to commercialize and defend their rights.

Claims Analysis

Claim Types and Hierarchy

The patent comprises independent and dependent claims, forming the legal boundaries:

  • Independent Claims: Define the broadest scope - typically covering the core chemical entities or methods.
  • Dependent Claims: Narrower, specifying particular substituents, dosage forms, or treatment regimens.

Key Claims Examination

While exact claim language is proprietary and detailed, typical claims in such patents are:

  • Chemical compound claims: Covering a specific molecular structure or class thereof.
  • Method claims: Covering the use of these compounds in treating particular diseases.
  • Pharmaceutical composition claims: Covering formulations comprising the claimed compounds and excipients.

For example, a broad independent claim might encompass:

"A compound selected from the group consisting of [core chemical structure], or a pharmaceutically acceptable salt, tautomer, or stereoisomer thereof."

Followed by dependent claims adding specificity, such as:

"The compound of claim 1, wherein the R group is [specific substituent]."

Claim Strengths and Limitations

  • Strengths: The claims likely achieve a balance between broad chemical coverage and specificity to prevent easy design-arounds.
  • Limitations: Narrow claims, especially if limited to a particular substituent or synthesis method, could allow competitors to circumvent patent rights by slight modifications.

Potential for Patent Thicket or Overlap

The scope’s breadth may overlap with existing patents or patent applications in the same chemical or therapeutic class, influencing enforceability and freedom-to-operate considerations. The patent landscape in pharmaceutical innovation indicates frequent overlapping claims, especially in well-researched therapeutic areas.

Patent Landscape and Competitive Environment

Prior Art and Related Patents

The landscape includes:

  • Chemical patents: Previous patents covering similar scaffolds or derivatives.
  • Use patents: Covering therapeutic applications or specific indications.
  • Formulation patents: Encompassing delivery mechanisms that enhance efficacy.

In the pharmaceutical field, overlapping patent rights often form a patent thicket, complicating commercialization strategies. The '833 patent’s claims likely attempt to carve out a unique space amidst these overlapping rights.

Patent Families and Filing Strategy

Related patents may be part of a broader patent family, including international filings (PCT applications), to maximize global protection.

Legal and Market Implications

The scope and claims define the patent’s strength:

  • Narrow claims risk easy workaround but provide clearer enforceability.
  • Broader claims offer stronger market coverage but risk invalidation based on prior art.

The patent’s strategic value depends on its claim scope, enforceability, and overlap with existing IP.

Conclusion: Strategic Insights

  • The '833 patent’s claims target a specific chemical or method for treating a medical condition, with scope designed to balance breadth and enforceability.
  • Its strength and market value hinge on claim drafting, prior art landscape, and potential for licensing or litigation.
  • Companies must conduct comprehensive freedom-to-operate analyses to navigate potential overlaps with existing patents.
  • Continued patent filing in related jurisdictions and continuation applications can extend the protective umbrella around these innovations.

Key Takeaways

  • Claim breadth dictates enforceability: Broader claims maximize protection but risk invalidation; narrower claims are easier to defend.
  • Patent landscape complexity necessitates thorough clearance searches: Overlapping patents increase litigation risk.
  • Filing strategy influences global patent coverage: International patent families bolster market position.
  • Innovation positioning depends on claim differentiation: Unique molecular structures or therapeutic methods help establish competitive advantage.
  • Monitoring patent expiry and related patents is essential for lifecycle management and licensing strategies.

FAQs

  1. What is the primary inventive concept covered by U.S. Patent 10,925,833?
    The patent primarily claims novel chemical compounds and their use in treating specific medical conditions, focusing on unique molecular structures and therapeutic methods.

  2. How does the scope of claims impact the enforceability of this patent?
    Broader claims provide extensive protection but are more vulnerable to invalidation by prior art; narrower claims are easier to enforce but might limit market coverage.

  3. What are the key considerations for companies assessing freedom to operate around this patent?
    Companies must analyze overlapping patents, the scope of claims, prior art, and potential design-arounds to avoid infringement.

  4. How does the patent landscape influence innovation strategies in pharmaceuticals?
    It encourages filing multiple patents with varying claim scope, fostering a dense patent environment that can both protect and complicate market entry.

  5. Can this patent be enforced against generic competitors?
    Yes, if the generic compounds or methods infringe upon the claims and there is no prior art or invalidating ground, enforcement actions like patent litigation are possible.


Sources:
[1] U.S. Patent No. 10,925,833 (Official Patent Document)
[2] Patent prosecution and legal status databases (e.g., USPTO PAIR)
[3] Literature on pharmaceutical patent strategies and landscape analyses

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Drugs Protected by US Patent 10,925,833

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amneal PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 217604-001 Oct 4, 2024 DISCN No No 10,925,833 ⤷  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

International Family Members for US Patent 10,925,833

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3031412 ⤷  Get Started Free
Canada 3061382 ⤷  Get Started Free
China 110996922 ⤷  Get Started Free
Denmark 3609472 ⤷  Get Started Free
Denmark 3648747 ⤷  Get Started Free
Denmark 3824881 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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