Details for Patent: 10,851,103

Which drugs does patent 10,851,103 protect, and when does it expire?

Patent 10,851,103 protects INGREZZA and INGREZZA SPRINKLE and is included in two NDAs.

This patent has fifty-two patent family members in thirty-two countries.

Summary for Patent: 10,851,103

Title:	Valbenazine salts and polymorphs thereof
Abstract:	Provided herein are salts of (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[- 2,1-a]isoquinolin-2-yl ester in amorphous and crystalline forms, and processes of preparation, and pharmaceutical compositions thereof. Also provided are methods of their use for treating, preventing, or ameliorating one or more symptoms of neurological disorders and diseases including hyperkinetic movement disorders or diseases.
Inventor(s):	McGee; Kevin (San Diego, CA), Zook; Scott E. (San Diego, CA), Carr; Andrew (Cambridge, GB), Bonnaud; Thierry (Cambridge, GB), Li; Bin-Feng (Suzhou Industrial Park, CN)
Assignee:	Neurocrine Biosciences, Inc. (San Diego, CA)
Application Number:	16/899,645
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

United States Patent 10,851,103: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,851,103, assigned to Neurocrine Biosciences, Inc., is a significant patent in the pharmaceutical sector, particularly related to the treatment of hyperkinetic disorders. This patent is part of a broader portfolio of patents surrounding valbenazine, a drug used to treat tardive dyskinesia. Here, we will delve into the scope, claims, and the patent landscape surrounding this patent.

Background on Valbenazine

Valbenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor, which is used primarily for the treatment of tardive dyskinesia, a condition characterized by involuntary, repetitive body movements that can be a side effect of long-term use of antipsychotic drugs[2][5].

Scope of the Patent

The patent 10,851,103 covers specific aspects of valbenazine, including its salts, polymorphs, and methods of treatment using these forms. Here are the key areas:

Valbenazine Salts and Polymorphs

The patent describes various salts and polymorphs of valbenazine, which are crucial for the stability, bioavailability, and efficacy of the drug. These include crystalline forms and specific chemical structures that enhance the pharmaceutical properties of valbenazine[1].

Methods of Treatment

The patent outlines methods for the treatment, prevention, or amelioration of symptoms associated with hyperkinetic disorders, such as tardive dyskinesia, using the specified salts and polymorphs of valbenazine. This includes dosing regimens and administration methods to optimize therapeutic outcomes[1].

Claims of the Patent

The claims of the patent are detailed and specific, ensuring broad protection for Neurocrine Biosciences, Inc. Here are some key claims:

Composition of Matter Claims

These claims cover the specific chemical structures of valbenazine salts and polymorphs, including their crystalline forms and purity levels. For example, the patent claims the [(2R,3R,11bR)-9,10-dimethoxy-3-(2-methylpropyl)-2,3,4,6,7,11b-hexahydro-1H-benzo[a]quinolizin-2-yl] (2S)-2-amino-3-methylbutanoate in various salt forms[1].

Method of Treatment Claims

These claims pertain to the methods of using valbenazine salts and polymorphs for treating hyperkinetic disorders. This includes specific dosages, administration routes, and treatment regimens[1].

Pharmaceutical Composition Claims

The patent also claims pharmaceutical compositions that include valbenazine salts and polymorphs, along with other ingredients such as preservatives, vehicles, and excipients. These compositions are designed to enhance the stability and efficacy of the drug[1].

Patent Landscape

The patent landscape surrounding 10,851,103 is complex and involves multiple patents and legal actions.

Related Patents

Neurocrine Biosciences, Inc. holds a portfolio of patents related to valbenazine, including U.S. Patent Nos. 10,065,952, 10,844,058, 10,857,137, and others. These patents collectively provide comprehensive protection for the drug and its various forms[2][5].

Patent Infringement Litigations

There have been several patent infringement lawsuits filed by Neurocrine Biosciences, Inc. against generic drug manufacturers, such as Crystal Pharmaceutical (Suzhou) Co., Ltd. and Sandoz Inc., who have sought FDA approval for generic versions of valbenazine before the expiration of the patents-in-suit. These lawsuits aim to protect the intellectual property rights of Neurocrine Biosciences, Inc.[2][5].

Global Patent System

The patent is part of the global patent system, with related applications and patents filed in various jurisdictions. Tools like the Global Dossier and Common Citation Document (CCD) facilitate the management and analysis of these global patent families[4].

Impact on the Pharmaceutical Industry

The patent 10,851,103 has significant implications for the pharmaceutical industry:

Innovation and R&D

The patent encourages innovation by protecting the intellectual property of Neurocrine Biosciences, Inc., allowing the company to invest in further research and development of valbenazine and related treatments.

Generic Competition

The patent landscape and ongoing litigations delay the entry of generic versions of valbenazine into the market, giving Neurocrine Biosciences, Inc. a competitive advantage and exclusive market share for a longer period.

Patient Access

While the patent protects the interests of the innovator company, it also affects patient access to affordable generic alternatives. The balance between innovation and accessibility is a critical issue in the pharmaceutical industry.

Key Takeaways

• Valbenazine Salts and Polymorphs: The patent covers specific salts and polymorphs of valbenazine, enhancing its pharmaceutical properties.
• Methods of Treatment: The patent includes methods for treating hyperkinetic disorders using these forms of valbenazine.
• Comprehensive Claims: The patent has detailed claims covering composition of matter, methods of treatment, and pharmaceutical compositions.
• Patent Landscape: The patent is part of a broader portfolio and involves ongoing patent infringement litigations.
• Industry Impact: The patent affects innovation, generic competition, and patient access to affordable treatments.

Frequently Asked Questions

What is the primary use of valbenazine?

Valbenazine is primarily used for the treatment of tardive dyskinesia, a condition characterized by involuntary, repetitive body movements.

What types of claims are included in the patent 10,851,103?

The patent includes composition of matter claims, method of treatment claims, and pharmaceutical composition claims.

Why are there ongoing patent infringement litigations related to this patent?

The litigations are to protect the intellectual property rights of Neurocrine Biosciences, Inc. against generic drug manufacturers seeking to enter the market before the expiration of the patents.

How does the patent affect patient access to valbenazine?

The patent delays the entry of generic versions of valbenazine, potentially limiting patient access to more affordable alternatives.

What tools are available for managing global patent families like those related to valbenazine?

Tools such as the Global Dossier and Common Citation Document (CCD) are available for managing and analyzing global patent families.

Cited Sources:

1. US10851103B2 - Valbenazine salts and polymorphs thereof - Google Patents
2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE - Insight.RPXCorp
3. Patent Claims Research Dataset - USPTO
4. Search for patents - USPTO
5. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE - Insight.RPXCorp

Drugs Protected by US Patent 10,851,103

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			Y	Y		TREATMENT OF TARDIVE DYSKINESIA
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-001	Apr 11, 2017	AB	RX	Yes	No			Y	Y		A METHOD OF TREATING HUNTINGTON'S CHOREA
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021		RX	Yes	No			Y	Y		A METHOD OF TREATING HUNTINGTON'S CHOREA
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021		RX	Yes	No			Y	Y		TREATMENT OF TARDIVE DYSKINESIA
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes			Y	Y		TREATMENT OF TARDIVE DYSKINESIA
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes			Y	Y		A METHOD OF TREATING HUNTINGTON'S CHOREA
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-001	Apr 30, 2024		RX	Yes	No			Y	Y		TREATMENT OF TARDIVE DYSKINESIA

International Family Members for US Patent 10,851,103

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016343633
Brazil	112018008460
Canada	3002074
Chile	2018001089
China	108473489
China	115304596
China	115322188