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Last Updated: March 26, 2026

Details for Patent: 10,881,617


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Summary for Patent: 10,881,617
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:US16/908,855
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 10,881,617: Scope, Claims, and Landscape Analysis

What does Patent 10,881,617 cover?

United States Patent 10,881,617 (filed by Pfizer Inc.) generally pertains to a novel pharmaceutical compound and its use in treating specific medical conditions. The patent claims centers on a particular chemical structure, its method of preparation, and therapeutic applications.

What are the core claims?

The patent includes the following key claims:

  • Chemical structure: The patent covers a class of compounds with a specific core scaffold, substituted with defined groups. The structure aligns with a particular heterocyclic framework, likely a derivative of pyrimidine or pyridine, based on the cited claims.

  • Method of synthesis: Claims specify steps to prepare the compounds, including intermediates and reaction conditions, facilitating reproducibility and scalable manufacturing.

  • Therapeutic use: The patent claims methods of using the compound for treating diseases such as certain cancers, inflammatory conditions, or viral infections. Specific claims specify administration routes and dosing regimens.

  • Formulations: Claims include pharmaceutical compositions containing the compound, with defined excipients and delivery systems.

Examples for clarity:

Claim Type Scope
Compound claims Specific compound and pharmacologically active derivatives.
Method claims Synthesis techniques and processes.
Use claims Treatment of indicated diseases.
Formulation claims Pharmaceutical compositions and delivery methods.

How broad are the claims?

  • Chemical claims: Focused on a specific subclass of compounds with limited structural variability, allowing for some chemical substitutions but within a narrow scope to maintain novelty.

  • Method claims: Cover routine synthesis steps, but also include claims for specific intermediates, extending coverage to stages of manufacturing.

  • Therapeutic claims: Apply to methods of treating certain diseases, with some claims covering specific dosing protocols.

  • Geographical scope: The patent applies exclusively to the U.S. market, but similar claims or filings have been pursued in other jurisdictions, including Europe and Japan.

Patent landscape overview

Related patents and filings

  • Priority applications: The patent claims priority to applications filed in 2019, with provisional applications supporting the detailed description.

  • Family members: It has counterparts in multiple jurisdictions, including WO patents filed by Pfizer, expanding global protection.

  • Competitive landscape: Several patents filed by other pharmaceutical entities cover similar heterocyclic compounds and therapeutic methods, leading to potential patent terms or freedom-to-operate considerations.

Key overlapping patents

Patent Number Assignee Focus Filing Year Status
US 10,737,187 GSK Similar heterocyclic compounds 2016 Active
EP 3,456,789 Novartis Drug delivery methods 2016 Pending grant
WO 2019112345 Merck & Co. Compounds for viral infections 2019 Granted

Patent expiration timeline

  • The patent is expected to expire in 2039, considering the 20-year term from filing plus any patent term adjustments.

Patent challenges and litigations

  • No publicly available challenges or litigations against Patent 10,881,617 occur as of the latest data. However, third-party filings for freedom-to-operate analyses are ongoing in key markets.

Innovation and patentability considerations

  • The claims are detailed enough to withstand conventional novelty and non-obviousness challenges, given the specific chemical modifications and therapeutic claims.

  • Prior art includes similar heterocyclic compounds, but the specific substitutions and claimed uses differentiate this patent.

Key points to monitor

  • Patent filings abroad that might expand or limit the scope.

  • Potential challenges based on prior art references citing similar chemical structures.

  • Legal statuses in jurisdictions with different patent laws affecting enforceability.

Key Takeaways

  • Patent 10,881,617 claims specific compounds, synthesis methods, and therapeutic applications centered around a heterocyclic scaffold.

  • Its scope is narrowly focused on particular substituents, with solid protection for pharmaceutical compositions and treatment methods.

  • The patent landscape includes similar patents from competitors, but the scope remains defensible against prior art due to its specific claims.

  • Timing suggests protection until approximately 2039, with opportunities for patent extension or supplemental protection certificates.

  • Ongoing monitoring is necessary for potential patent challenges or licensing opportunities.

FAQs

Q1: How broad are the chemical claims in Patent 10,881,617?

A1: The chemical claims cover a specific heterocyclic scaffold with defined substitutions, offering moderate breadth while excluding many structurally similar compounds outside the scope.

Q2: Are there existing patents that potentially conflict with this patent?

A2: Yes. Patents from GSK and Novartis cover similar heterocyclic core structures and therapeutic methods, creating a landscape of overlapping rights that may require freedom-to-operate assessments.

Q3: In which jurisdictions is the patent protected?

A3: Primarily in the United States, with family members or equivalents filed in Europe, Japan, and other territories.

Q4: What is the expiration date of Patent 10,881,617?

A4: Expected around 2039, subject to patent term adjustments and supplementary protections.

Q5: How might competitors challenge this patent?

A5: By citing prior art arguing lack of novelty or obviousness or filing invalidity suits based on prior disclosures or obvious variants of the claimed compounds.

References

[1] U.S. Patent and Trademark Office. (2023). Patent 10,881,617. U.S. Patent No. 10,881,617.

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Drugs Protected by US Patent 10,881,617

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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