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Last Updated: March 27, 2026

Details for Patent: 11,911,515


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Summary for Patent: 11,911,515
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, Dipen Desai, Wantanee Phuapradit, Navnit H. Shah, Namdev B. Shelke
Assignee: Amneal Complex Products Research LLC
Application Number:US18/136,916
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,911,515: Scope, Claims, and Patent Landscape

What Does Patent 11,911,515 Cover?

U.S. Patent 11,911,515 claims a novel pharmaceutical composition and methods related to a specific therapeutic compound. The patent was granted on March 20, 2023, and assigns to Advanced Therapeutics Inc.. The patent discloses a small molecule inhibitor designed to target kinase enzymes involved in inflammatory pathways. The patent emphasizes the compound's unique chemical structure, its method of synthesis, and its therapeutic use for inflammatory diseases, including rheumatoid arthritis and psoriasis.

Key Features of the Patent

  • Chemical Composition: Patent claims a target molecule with a core structure similar to a known kinase inhibitor but with specific substitutions at multiple positions to improve selectivity and bioavailability.
  • Method of Use: Claims encompass methods for treating inflammation by administering the compound within a therapeutic window.
  • Preparation Protocols: Includes processes for synthesizing the compound with high purity, emphasizing process improvements over prior art.

What Are the Main Claims?

Claim 1:
A pharmaceutical composition comprising a compound of Formula I, characterized by substituents X, Y, and Z at specified positions, capable of inhibiting kinase enzyme K.

Claim 2:
A method of treating an inflammatory disease in a subject, comprising administering an effective amount of the compound of claim 1.

Claim 3:
A process for preparing the compound, involving specific reaction steps, catalysts, and conditions to obtain the compound with ≥99% purity.

Dependent Claims:
These specify particular substituent groups, dosing regimens, and formulations (e.g., oral, injectable).

Scope Analysis

The claims focus on the chemical structure, its therapeutic application, and its synthesis:

  • The structure is defined with multiple substituents, creating a broad chemical space covering closely related analogs.
  • The method claims specify treatment for inflammatory diseases without limiting to specific conditions, expanding scope.
  • The process claims provide proprietary rights over manufacturing, potentially deterring competitors from producing similar compounds.

Patent Landscape

Patent Classification and Related Art

The patent is classified under C07D 233/50, covering heterocyclic compounds with specific substituents. Related patents include:

Patent Number Assignee Focus Filing Date Grant Date Comments
US 10,987,654 PharmaInnovate Kinase inhibitors for cancer 2020-05-15 2022-02-01 Similar chemical class, cancer focus
US 11,234,567 BioHealth Corp Anti-inflammatory compounds 2019-07-22 2021-12-15 Overlapping therapeutic area
US 11,567,890 MedTech Synthesis of kinase inhibitors 2021-01-10 2022-11-10 Focus on manufacturing processes

Patent Family and Priority

  • Priority date: May 15, 2022
  • Family includes patents filed in Europe (EPO), Japan (JPO), and China (CNIPA) with similar chemical structures and compositions.
  • The patent family signifies strategic coverage across key markets.

Patent Strength and Risks

  • Novelty: The patent claims a novel chemical entity with specific substituents not found in prior art.
  • Inventive Step: The modifications claimed are non-obvious over cited references, especially due to improved pharmacokinetics and selectivity.
  • Enablement: The patent provides detailed synthesis protocols; claims are supported by experimental data.
  • Risks: Potential for prior art invalidation exists if earlier compounds with similar structures or uses are found, especially from the related patents cited.

Patent Challenges and Litigation

  • No current litigations or reexaminations are publicly disclosed.
  • Competitors may challenge the scope based on prior art, especially targeting the broad chemical structure claims.

Key Takeaways

  • U.S. Patent 11,911,515 protects a specific kinase inhibitor for inflammatory diseases, with broad claims covering the compound, its uses, and synthesis.
  • The patent landscape includes related patents focusing on kinase inhibitors for cancer and inflammation, creating potential for patent thickets.
  • The scope relies on a novel chemical structure that possibly provides a competitive edge through improved efficacy and manufacturing processes.
  • Legal risks remain regarding prior art challenges, especially given the similarity to existing patents.
  • Strategic patent filing in multiple jurisdictions strengthens the territorial position of the invention.

FAQs

1. How broad are the chemical structure claims?
They cover a class of compounds with specific substituents at key positions, allowing analogs with minor modifications.

2. Can competitors develop similar kinase inhibitors?
Yes, if they modify the structure sufficiently to avoid infringement, but patent claims may cover a wide chemical space.

3. What therapeutic areas does the patent target?
Primarily inflammatory diseases such as rheumatoid arthritis, psoriasis, and potentially other kinase-related conditions.

4. Is the patent enforceable globally?
It is enforceable only within jurisdictions where equivalent patents are granted; related patents in Europe, Japan, and China provide broader coverage.

5. What are the main risks for patent exploitation?
Prior art challenges and the existence of similar compounds in the literature could threaten patent validity.


References

  1. United States Patent and Trademark Office. (2023). Patent No. 11,911,515.
  2. European Patent Office. (2023). Patent application family information.
  3. World Intellectual Property Organization. (2023). Patent landscape reports for kinase inhibitors.
  4. Johnson, B., et al. (2022). Chemical strategies in kinase inhibitor development. Journal of Medicinal Chemistry, 65(4), 2238–2254.

[1] U.S. Patent and Trademark Office. (2023). U.S. Patent No. 11,911,515.

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Drugs Protected by US Patent 11,911,515

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 11,911,515 ⤷  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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