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Last Updated: January 5, 2025

Details for Patent: 10,952,997


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Summary for Patent: 10,952,997
Title:Methods for the administration of certain VMAT2 inhibitors
Abstract: Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-a-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]i- soquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof, to a patient in need thereof wherein the patient is also being administered a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
Inventor(s): O'Brien; Christopher F. (San Diego, CA), Bozigian; Haig P. (San Diego, CA)
Assignee: Neurocrine Biosciences, Inc. (San Diego, CA)
Application Number:16/870,423
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

United States Patent 10,952,997: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,952,997, hereafter referred to as the '997 patent, is part of a broader patent landscape involving various pharmaceutical and biotechnology innovations. This patent is particularly significant in the context of neuropharmacology and the development of treatments for neurological disorders. Here, we will delve into the scope, claims, and the surrounding patent landscape of this patent.

Background

The '997 patent is associated with Neurocrine Biosciences, Inc., a company known for its work in developing treatments for neurological and endocrine-related disorders. This patent is one of several that Neurocrine has filed to protect its intellectual property related to specific pharmaceutical compounds and their methods of administration.

Scope of the Patent

Overview

The '997 patent pertains to methods and compositions related to the administration of certain pharmaceutical compounds, specifically focusing on vesicular monoamine transport 2 (VMAT2) inhibitors. VMAT2 inhibitors are used in the treatment of various neurological conditions, including tardive dyskinesia and other movement disorders[2][5].

Key Aspects

  • VMAT2 Inhibitors: The patent covers the administration of VMAT2 inhibitors, such as valbenazine, which is a key compound developed by Neurocrine Biosciences.
  • Methods of Administration: The patent details various methods for administering these inhibitors, including specific dosing regimens and formulations.
  • Therapeutic Uses: The scope includes the therapeutic applications of these compounds in treating neurological disorders.

Claims of the Patent

Independent Claims

The '997 patent includes several independent claims that define the scope of the invention. These claims typically cover:

  • Specific Compounds: Claims related to the chemical structure and synthesis of VMAT2 inhibitors like valbenazine.
  • Methods of Administration: Claims detailing the methods by which these compounds are administered, including dosing schedules and formulations.
  • Therapeutic Methods: Claims covering the use of these compounds in treating specific neurological conditions.

Dependent Claims

Dependent claims further specify and narrow down the scope of the independent claims. These may include:

  • Specific Dosing Regimens: Detailed descriptions of how the compounds should be administered over time.
  • Formulation Details: Claims related to the specific formulations of the compounds, including excipients and preservatives.
  • Patient Populations: Claims specifying the patient groups for which the treatment is intended.

Patent Landscape

Related Patents

The '997 patent is part of a larger family of patents held by Neurocrine Biosciences. Other related patents include:

  • U.S. Patent Nos. 10,993,941, 11,026,931, 11,026,939, and 11,040,029: These patents also cover various aspects of VMAT2 inhibitors and their administration methods[2][5].
  • U.S. Patent Nos. 10,065,952, 10,844,058, 10,851,103, 10,851,104, 10,857,137, 10,857,148, 10,874,648, 10,906,902, 10,906,903, 10,912,771, 10,919,892, and 10,940,141: These patents are part of the broader portfolio related to Neurocrine’s pharmaceutical innovations[2][5].

Litigation and Enforcement

Neurocrine Biosciences has been involved in several patent infringement lawsuits to protect its intellectual property. For example:

  • Neurocrine Biosciences, Inc. v. Crystal Pharmaceutical (Suzhou) Co., Ltd. et al.: This lawsuit involves allegations of patent infringement related to the ANDA filing for generic versions of valbenazine[2][5].

Global Patent Family

The '997 patent is part of a global patent family, with corresponding patents filed in other jurisdictions. The Global Dossier service provided by the USPTO allows users to view the file histories of related applications from participating IP Offices, which can include the IP5 Offices (the United States, Europe, Japan, Korea, and China)[4].

Impact on the Pharmaceutical Industry

Protection of Intellectual Property

The '997 patent and related patents provide significant protection for Neurocrine Biosciences’ intellectual property, allowing the company to maintain market exclusivity for its innovative treatments.

Innovation and Research

These patents encourage continued innovation in the field of neuropharmacology by protecting the investments made in research and development.

Generic Competition

The litigation surrounding these patents highlights the challenges faced by generic manufacturers seeking to enter the market. The certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) by generic manufacturers, alleging that the claims of the patents are invalid, unenforceable, or will not be infringed, are a common strategy in such cases[2][5].

Key Takeaways

  • VMAT2 Inhibitors: The '997 patent focuses on the administration of VMAT2 inhibitors, such as valbenazine.
  • Methods of Administration: The patent details specific methods and dosing regimens for these compounds.
  • Therapeutic Uses: The scope includes treating neurological disorders like tardive dyskinesia.
  • Patent Landscape: The patent is part of a broader portfolio of related patents held by Neurocrine Biosciences.
  • Litigation: Neurocrine has been involved in patent infringement lawsuits to protect its intellectual property.

FAQs

What is the main subject of the '997 patent?

The '997 patent primarily deals with methods and compositions related to the administration of VMAT2 inhibitors, such as valbenazine.

Which company holds the '997 patent?

The '997 patent is held by Neurocrine Biosciences, Inc.

What are the therapeutic uses of the compounds covered by the '997 patent?

The compounds covered by the '997 patent are used in treating neurological disorders, including tardive dyskinesia.

Why is the '997 patent significant in the pharmaceutical industry?

The '997 patent is significant because it protects Neurocrine Biosciences’ intellectual property related to innovative treatments, allowing the company to maintain market exclusivity.

Are there any ongoing litigation cases related to the '997 patent?

Yes, Neurocrine Biosciences has been involved in several patent infringement lawsuits related to the '997 patent and other related patents.

Sources

  1. US10952997B2 - Methods for the administration of certain VMAT2 inhibitors - Google Patents
  2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE NEUROCRINE BIOSCIENCES, INC. Plaintiff, v. CRYSTAL PHARMACEUTICAL (SUZHOU) CO., LTD. and CRYSTAL PHARMATECH CO., LTD. Defendants. - Insight.RPXCorp
  3. Patent Claims Research Dataset - USPTO
  4. Search for patents - USPTO - USPTO
  5. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE Civil Action No. COMPLAINT FOR PATENT INFRINGEMENT Neurocrine Biosciences, Inc. (“Neurocrine”), by way of Complaint against Defendants Sandoz Inc., Sandoz AG and Sandoz International GmbH (“Sandoz Int’l”) - Insight.RPXCorp

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Drugs Protected by US Patent 10,952,997

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-001 Apr 11, 2017 AB RX Yes No 10,952,997 ⤷  Subscribe TREATMENT OF TARDIVE DYSKINESIA ⤷  Subscribe
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 AB RX Yes No 10,952,997 ⤷  Subscribe TREATMENT OF TARDIVE DYSKINESIA ⤷  Subscribe
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 AB RX Yes Yes 10,952,997 ⤷  Subscribe TREATMENT OF TARDIVE DYSKINESIA ⤷  Subscribe
>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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