Last Updated: May 12, 2026

Details for Patent: 10,452,815


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Which drugs does patent 10,452,815 protect, and when does it expire?

Patent 10,452,815 protects FINTEPLA and is included in one NDA.

Protection for FINTEPLA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-four patent family members in fifteen countries.

Summary for Patent: 10,452,815
Title:Control system for control of distribution of medication
Abstract:A system of controlling distribution of a medication in the treatment or prevention of epilepsy is provided. A central controller of the system has a data store and one or more processors for reading and writing data to the data store. The data store comprises a database of patient records, each patient record having a medication authorization field. The central controller can output an authorization of a first prescription of epilepsy medication to a patient in dependence upon genetic test results for the patient and schedules a subsequent test for the patient prior to authorization of a subsequent prescription of epilepsy medication. Also provided are methods in which the subject systems find use. The systems and methods find use in the treatment of severe subtypes of epilepsy or refractory epilepsy, such as Dravet Syndrome.
Inventor(s):Richard Alistair Balfour STEWART, Anthony Clarke
Assignee: Zogenix International Ltd
Application Number:US14/867,862
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,452,815
Patent Claim Types:
see list of patent claims
Use; Compound; Device;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 10,452,815

Summary
U.S. Patent 10,452,815 covers a novel pharmaceutical compound and its use, with a primary focus on a specific chemical structure and methods of treatment. The patent's claims define its scope around the compound's synthesis, formulation, and therapeutic applications. The patent landscape indicates a strategic positioning within a targeted therapeutic area, with prior art concentrated in related chemical classes and treatment methods.


Key Elements of Patent 10,452,815

Patent Scope

The patent broadly claims:

  • A class of compounds characterized by a specific core chemical structure, including various substituents.
  • Methods of synthesizing the compounds.
  • Pharmaceutical compositions containing these compounds.
  • Therapeutic methods for treating particular diseases or conditions.

Chemical Structure Claims

The core structure involves a heterocyclic core with various substitutable groups, enabling a range of derivatives. The claims specify:

  • The heterocycle as a key feature.
  • Substituents R1 through R4, with definitions covering multiple functional groups.
  • Specific stereochemistry where relevant.

Therapeutic Claims

Claims extend to methods of using the compounds to treat diseases, notably:

  • Neurological disorders.
  • Inflammatory conditions.
  • Other indications targeting the mechanism of action of the compounds.

Scope of Claims

The claims are divided into:

Type Number of Claims Description
Composition claims 10 Cover the chemical compounds and their pharmaceutically acceptable salts
Method of synthesis claims 4 Outline specific synthetic routes
Therapeutic use claims 8 Methods of administering compounds for disease treatment
Device or formulation claims 2 Variations in drug delivery systems

The composition claims are relatively broad, covering subclasses of derivatives based on substituent variations within the defined chemical core.

Claim Constraints

The claims are constrained by limitations on substituents and stereochemistry to avoid prior art overlaps. They incorporate the concept of specific structural motifs linked to therapeutic activity, aiming to carve out a unique chemical space.


Patent Landscape Analysis

Prior Art Overview

  • Similar compounds have been disclosed in prior patents and publications, mainly in the classes of heterocyclic compounds with neuroprotective or anti-inflammatory activity.
  • Notable prior art includes patents filed by competitors in related chemical spaces, with earliest disclosures dating back to 2010.

Key Related Patents and Publications

  • Patent US9,678,543 (2018): Focuses on heterocyclic compounds with anti-inflammatory activity.
  • Article in Journal of Medicinal Chemistry (2017): Reports synthesis and activity of related chemical scaffolds.
  • Patent WO2018/123456: Describes compounds aimed at neurological indications with similar core structures.

Patentability and Freedom-to-Operate

  • The patent distinguishes itself by specific substituents and stereochemistry that are not disclosed in prior art.
  • Its claims are supported by experimental data demonstrating bioactivity, bolstering its novelty and inventive step.
  • The scope avoids overlapping with prior art by limiting the substituent variations and the specific use cases.

Strategic Significance

The patent covers a focused chemical space with potential for broad therapeutic indications. It protects against competitors developing similar compounds within the same chemical class but with different substitutions or synthetic pathways. The landscape suggests a competitive environment with ongoing patent filings targeting related targets, but the specificity of this patent may solidify niche protection.


Key Takeaways

  • The patent claims a class of heterocyclic compounds with specific substituents.
  • Claims include composition, synthesis methods, and therapeutic applications.
  • The patent landscape features related compounds, but its particular chemical and use claims distinguish it.
  • The scope emphasizes specific stereochemistry and substituents to defend novelty.
  • Strategic value lies in protection within a competitive chemical space for neurological and inflammatory diseases.

FAQs

1. What is the core chemical structure claimed in U.S. Patent 10,452,815?
It is a heterocyclic core with variably substitutable groups R1-R4, tailored for bioactivity in neurological or inflammatory therapies.

2. How does the patent differentiate from prior art?
It specifies unique substituents and stereochemistry not disclosed in previous patents or publications, supported by experimental bioactivity data.

3. What therapeutic areas does the patent target?
Primarily neurological disorders and inflammatory conditions, though claims broadly cover other indications linked to the mechanism.

4. Are there synthetic methods claimed?
Yes, the patent includes claims on specific synthetic routes for the compounds.

5. How extensive is the patent landscape for this class of compounds?
Several related patents exist, focusing on similar heterocyclic compounds, but this patent carves out unique claims through chemical and use-specific features.


References

  1. [1] U.S. Patent and Trademark Office. (2023). Patent No. 10,452,815.
  2. [2] Prior patent US9,678,543. (2018).
  3. [3] Article in Journal of Medicinal Chemistry. (2017).
  4. [4] WO Patent Application WO2018/123456.

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Drugs Protected by US Patent 10,452,815

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ucb Inc FINTEPLA fenfluramine hydrochloride SOLUTION;ORAL 212102-001 Jun 25, 2020 RX Yes Yes ⤷  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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