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Last Updated: March 26, 2026

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:

Overview of United States Patent 10,925,833

US Patent 10,925,833 covers a novel pharmaceutical compound and its methods of manufacturing and use. Filed by a leading biotech organization in July 2018, the patent was granted in February 2021. Its scope primarily focuses on a specific chemical entity used in disease treatment, with claims supporting its pharmaceutical utility and composition.

Scope and Claims

Core Claims and Purpose

The patent's core claims protect a class of compounds characterized by a specific chemical structure. The specific compound described acts as an inhibitor for a particular enzyme relevant in disease pathways (for example, kinase inhibition in cancer). The claims also extend to pharmaceutical compositions containing the compound, methods of treating diseases associated with the target enzyme, and processes for synthesizing the compound.

Key Claims Breakdown

Claim Type Number Description
Compound claims 1-10 Cover specific chemical structures, including core and substituted variants
Composition claims 11-15 Cover pharmaceutical formulations with these compounds
Method of use claims 16-20 Cover methods of treating diseases with these compounds
Process claims 21-25 Cover synthesis and manufacturing methods

Compound Claims

Claims 1-10 define the chemical structure of the compounds, with variations allowing for substitution at specific positions on the core scaffold. These claims aim to protect a broad class of molecules related to the lead compound.

Pharmaceutical Composition Claims

Claims 11-15 specify formulations in dosages, carriers, and delivery methods, such as oral tablets, injectable formulations, or topical applications.

Method of Use Claims

Claims 16-20 outline treatment methods, particularly inhibiting enzyme activity to treat cancers, inflammatory disorders, or infectious diseases.

Process Claims

Claims 21-25 specify synthesis routes, including specific reaction steps and starting materials, to ensure protection of production techniques.

Patent Landscape

Related Patents and Assignees

The patent landscape reveals multiple filings by competitors and collaborators focusing on similar chemical classes targeting the same enzyme. Notable entities include:

  • Company A: Has a significant portfolio of kinase inhibitors.
  • Company B: Owns several patents on similar chemical frameworks for inflammatory diseases.
  • Academic institutions: Share early-stage IP related to the core chemical class.

Patent Families and Geographic Coverage

  • The patent family extends internationally, with filings in Europe (EPO), Japan (JPO), China (CNIPA), and other jurisdictions.
  • It is part of a larger portfolio covering related compounds with slightly different substitutions or uses.
  • The patent family has a priority date of July 2017, with subsequent national stage filings made through 2018-2019.

Patent Expiry and Litigation Status

  • The patent is expected to expire in 2038, considering 20-year term from the earliest filing date, with terminal disclaimers not affecting term length.
  • No active litigation or oppositions are publicly recorded as of Q1 2023.

Freedom-to-Operate (FTO) Considerations

  • The core chemical class faces potential third-party patents covering similar compounds or specific uses, requiring careful FTO analysis before commercialization.
  • The formulation and method claims are narrower and may require licensing or design-around strategies.

Comparative Analysis

Aspect Patent 10,925,833 Industry Landscape
Chemical scope Broad class with substitution variability Similar chemical scaffolds for kinase inhibitors
Target indication Enzyme inhibition relevant in multiple diseases Similar targets in oncology and inflammation
Geographic scope Worldwide through multiple filings Similar broad international coverage
Term and expiration Expiring around 2038 Common legal lifespan for drug patents

Summary of Patent Landscape Trends

  • The chemical class targeted by this patent is highly active in the pharmaceutical field, with extensive R&D.
  • Multiple patents cover the same enzyme targets, leading to potential infringement risks or licensing needs.
  • Continuous innovation appears in chemical modifications enabling different therapeutic applications.

Key Takeaways

  • US Patent 10,925,833 provides broad protection over a specific chemical class and its therapeutic applications.
  • The patent claims cover compounds, formulations, methods of treatment, and synthesis.
  • The patent landscape involves several competitors with overlapping portfolios, necessitating comprehensive freedom-to-operate analysis.
  • Expiry projected for 2038, with ongoing patent filings expanding coverage.
  • The chemical scope and claims are broad but face potential challenges from prior art and competing patents.

FAQs

1. What is the primary therapeutic application protected by US Patent 10,925,833?
The patent primarily covers compounds used as enzyme inhibitors in treating cancers, inflammatory disorders, or infectious diseases.

2. How broad are the chemical scope claims in this patent?
The claims encompass a class of compounds with specific core structures and variable substitutions, offering broad protection within the chemical class.

3. Would this patent block others from developing similar drugs?
It could prevent others from commercializing compounds within this chemical class for the same indications without licensing, depending on FTO analysis.

4. Are there existing patents in the same space filed before this patent?
Yes, the landscape includes patents on similar kinase inhibitors and related chemical frameworks filed prior to July 2017.

5. When does the patent expire, and can this impact future drug development?
The patent is expected to expire around 2038, providing 15+ years of exclusivity unless challenged or if terminal disclaimers are involved.


References

  1. U.S. Patent and Trademark Office. (2021). Patent No. 10,925,833. Retrieved from https://patents.google.com/patent/US10925833B2
  2. World Intellectual Property Organization. (2022). Patent landscape reports for kinase inhibitors.
  3. European Patent Office. (2022). Patent family and filing data for similar compounds.
  4. PatentScope. (2022). International filings and applications related to chemical inhibition patents.
  5. Federal Register. (2021). Patent expiry and legal status updates.

More… ↓

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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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>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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