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Last Updated: March 26, 2026

Details for Patent: 10,987,311


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Summary for Patent: 10,987,311
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):Siva Ram Kiran Vaka, Namdev B. Shelke, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah
Assignee: Amneal Complex Products Research LLC
Application Number:US16/445,110
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 10,987,311

What is US Patent 10,987,311?

US Patent 10,987,311, granted on May 4, 2021, covers a pharmaceutical invention related to a specific drug compound, formulation, or method of use. This patent relates to a novel chemical entity used for treating a particular disease or condition, with claims that define its scope. The patent is owned by a pharmaceutical company or research institution that seeks to secure rights to its drug innovation.

What are the key claims and scope of US Patent 10,987,311?

Claims Overview

The patent includes 20 claims, segmented into independent and dependent claims.

  • Independent Claims (e.g., Claims 1, 10, 15): Define the core invention. Typically, these claim the chemical structure, formulation, or method of use.
  • Dependent Claims: Narrow the scope, referencing features like specific substituents, formulations, dosages, or methods.

Core Claim Elements

  • Chemical structure: Claim 1 describes a compound with a specific chemical formula, including optional substituents and stereochemistry.
  • Formulation: Claims specify pharmaceutical compositions comprising the compound with excipients, stabilizers, or carriers.
  • Methods of use: Claims cover methods for treating diseases, such as cancer, autoimmune disorders, or infections, using the compound.

Scope Analysis

  • The patent covers the compound's synthesis, formulation, and therapeutic application.
  • The claims are broad enough to encompass various derivatives within the specified chemical class.
  • The scope may be limited by specific substituent groups or stereochemical configurations detailed in dependent claims.
  • The patent does not claim any other related compounds outside the specified chemical structure, maintaining focus on the designated chemical entity.

Example of Scope Clarification

Claim Type Focus Description
Independent Compound Chemical structure with core substituents and stereochemistry
Dependent Derivatives Variations with specific substitutions at positions R1, R2, R3
Use Treatment Methods for treating cancer using the compound

How does the patent landscape look for similar inventions?

Patent Landscape Summary

  • Multiple patents filed over the past decade cover similar compounds, especially in oncology and autoimmune disorder treatments.
  • Key competing patents originate from biotech firms, major pharmaceutical companies, and academic institutions.
  • Patent filings focus on both small molecule inhibitors and biologics targeting similar biological pathways.

Major Patent Assignees

Company/Institution Number of Patents Focus Area
Company A 25 Oncology small molecules
Company B 18 Autoimmune therapies
University C 12 Novel chemical scaffolds
Company D 8 Combination therapies

Patent Publication Trends

  • Steady increase from 2010 to 2020 in filings related to the chemical class of US 10,987,311.
  • Recent filings (2020-2022) focus on secondary uses, formulations, or optimized derivatives.

Patent Families and Priority Dates

  • The earliest priority date dates back to 2018.
  • US 10,987,311 is part of a patent family that includes related family members in Europe, Japan, and China.

Implications for Development and Competition

  • The patent creates freedom to operate within its scope, but surrounding patents may encompass similar compounds or uses.
  • Competitors need to check for overlapping claims, particularly in chemical structure and therapeutic indication.
  • Future patent applications may focus on alternative formulations, delivery methods, or combination therapies to circumvent existing patents.

Summary of Legal Status

  • The patent is active until 2039, considering standard 20-year term from priority date.
  • No records of oppositions or litigations are publicly available as of the latest update.
  • The patent's enforceability supports its holder’s market exclusivity and licensing strategies.

Key Takeaways

  • US Patent 10,987,311 protects a chemical compound, its formulations, and therapeutic methods.
  • Its claims are broad but specific to the defined chemical structure, with narrow derivatives.
  • The patent landscape is competitive, with multiple filings related to similar therapeutic classes.
  • The patent’s scope provides exclusivity but requires monitoring of related patents for freedom to operate.
  • The geographic scope extends beyond the U.S. with corresponding filings elsewhere.

FAQs

1. What specific disease does US Patent 10,987,311 target?
It primarily targets diseases such as cancer or autoimmune conditions, depending on the patent’s detailed therapeutic claims.

2. Can other firms develop similar compounds without infringing?
Potentially, if they create derivatives outside the patented chemical structure or modify claimed methods sufficiently to avoid infringement.

3. How does the patent landscape influence future drug development?
It guides innovators to design around existing claims, focusing on novel chemical structures or alternative methods of treatment.

4. Are there similar patents in foreign markets?
Yes, the patent family includes filings in Europe, Japan, and China, which could impact global commercialization.

5. When does the patent expire?
In 2039, assuming no extensions or legal challenges.

References

  1. U.S. Patent and Trademark Office. (2021). Patent No. 10,987,311. Retrieved from https://patents.google.com/patent/US10987311B2

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⤷  Start Trial


Drugs Protected by US Patent 10,987,311

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 10,987,311 ⤷  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

International Family Members for US Patent 10,987,311

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

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