Details for Patent: 9,125,939

Which drugs does patent 9,125,939 protect, and when does it expire?

Patent 9,125,939 protects ABILIFY and ABILIFY MYCITE KIT and is included in three NDAs.

This patent has thirty-seven patent family members in twenty-six countries.

Summary for Patent: 9,125,939

Title:	Carbostyril derivatives and mood stabilizers for treating mood disorders
Abstract:	The pharmaceutical composition of the present invention comprises a carbostyril derivative which is a dopamine-sero-tonin system stabilizer and a mood stabilizer in a pharmaceutically acceptable carrier. The carbostyril derivative may be aripiprazole or a metabolite thereof. The mood stabilizer may include but is not limited to lithium, valproic acid, divalproex sodium, carbamaza-pine, oxcarbamazapine, zonisamide, lamotragine, topiramate, gabapentin, levetiracetam or clonazepam. These compositions are used to treat patients with mood disorders, particularly bipolar disorder with or without psychotic features, mania or mixed episodes. Methods are provided for separate administration of a carbostyril derivative and a mood stabilizer to a patient with a mood disorder.
Inventor(s):	Kikuchi; Tetsuro (Tokushima, JP), Iwamoto; Taro (Princeton, NJ), Hirose; Tsuyoshi (Tokushima, JP)
Assignee:	Otsuka Pharmaceutical Co., Ltd. (Tokyo, JP)
Application Number:	10/556,600
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,125,939
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 9,125,939: A Detailed Analysis

Introduction

The United States Patent 9,125,939, titled "Carbostyril derivatives and mood stabilizers for treating mood disorders," is a significant patent in the field of psychiatric pharmacology. This patent, granted on September 8, 2015, covers compounds and methods for treating various mood disorders, including bipolar disorder and major depressive disorder.

Background

Mood disorders, such as bipolar disorder and major depressive disorder, are complex psychiatric conditions that affect millions of people worldwide. The treatment of these disorders often involves a range of pharmacological interventions, including mood stabilizers and antipsychotic medications. Aripiprazole, a compound mentioned in this patent, is a well-known antipsychotic medication with partial agonist activity at the 5-HT1A receptor, which is beneficial in treating types of depression and bipolar disorder[1].

Patent Overview

Inventors and Assignees

The patent was assigned to Otsuka Pharmaceutical Co., Ltd., a Japanese pharmaceutical company known for its innovative treatments in various therapeutic areas, including psychiatry.

Claims

The patent includes multiple claims that define the scope of the invention. Here are some key aspects:

• Chemical Compounds: The patent claims cover specific carbostyril derivatives, which are chemical compounds with potential therapeutic effects on mood disorders. These compounds are described in detail, including their structural formulas and methods of synthesis[1].
• Mood Stabilizers: The patent also claims mood stabilizers, including combinations of the carbostyril derivatives with other known mood stabilizers like lithium, valproate, and aripiprazole. These combinations are intended to enhance the therapeutic efficacy in treating mood disorders[1].
• Methods of Treatment: The claims include methods for treating mood disorders, such as bipolar I disorder, bipolar depression, and major depressive disorder, using the claimed compounds and combinations[1].

Scope of the Patent

Therapeutic Indications

The patent covers a broad range of therapeutic indications, including:

• Bipolar I Disorder: The treatment of manic and mixed episodes associated with bipolar I disorder.
• Bipolar Depression: The treatment of depressive episodes in bipolar disorder.
• Major Depressive Disorder: The adjunctive treatment of major depressive disorder[1][2].

Compound Specificity

The patent specifies the carbostyril derivatives and their use in combination with other drugs. For example, the combination of these derivatives with aripiprazole is highlighted for its potential in treating mood disorders[1].

Patent Landscape

Related Patents

The patent landscape surrounding US 9,125,939 includes several related patents that cover similar therapeutic areas and compounds. For instance:

• Patent 8,642,600: Covers the acute treatment of manic and mixed episodes associated with bipolar I disorder, among other indications[2].
• Patent 9,089,567: Relates to the treatment of cognitive impairments and schizophrenia, indicating a broader scope of psychiatric treatments by the same assignee[4].

Litigation and Regulatory Status

The patent has been involved in litigation related to generic drug approvals. For example, Zydus Pharmaceuticals (USA) Inc. filed an ANDA (Abbreviated New Drug Application) that included paragraph IV certifications challenging the validity and enforceability of several patents, including the '939 patent. However, these cases were eventually dismissed[2].

Impact on Treatment

Clinical Significance

The compounds and methods described in this patent have significant clinical implications. Aripiprazole, for instance, is known for its efficacy in treating bipolar disorder and major depressive disorder, and the combination with carbostyril derivatives could offer enhanced therapeutic benefits[1].

Patient Compliance

The use of specific compounds and combinations can improve patient compliance and treatment outcomes. For example, the combination therapies mentioned in the patent can help in managing complex mood disorders more effectively[1].

Future Directions

Research and Development

The patent opens avenues for further research and development in psychiatric pharmacology. The exploration of new carbostyril derivatives and their combinations with existing drugs could lead to the discovery of more effective treatments for mood disorders.

Regulatory Considerations

Future developments will need to navigate the regulatory landscape carefully, considering the existing patents and litigation history. This includes ensuring compliance with FDA regulations and addressing any potential patent infringement issues[2].

Key Takeaways

• Therapeutic Coverage: The patent covers a range of mood disorders, including bipolar I disorder and major depressive disorder.
• Compound Innovations: It introduces new carbostyril derivatives and their combinations with known mood stabilizers.
• Clinical Implications: The patent has significant clinical implications, particularly in enhancing the efficacy of treatments for complex mood disorders.
• Regulatory and Litigation Aspects: The patent has been involved in litigation related to generic drug approvals and highlights the importance of regulatory compliance.

FAQs

What is the main focus of the United States Patent 9,125,939?

The main focus of the patent is on carbostyril derivatives and mood stabilizers for treating mood disorders such as bipolar disorder and major depressive disorder.

Which compounds are specifically mentioned in the patent?

The patent mentions carbostyril derivatives and their combinations with other drugs like aripiprazole, lithium, and valproate.

What are the therapeutic indications covered by this patent?

The patent covers the treatment of manic and mixed episodes associated with bipolar I disorder, bipolar depression, and major depressive disorder.

Has this patent been involved in any litigation?

Yes, the patent has been involved in litigation related to generic drug approvals, specifically with Zydus Pharmaceuticals (USA) Inc.

What is the significance of aripiprazole in this patent?

Aripiprazole is significant because it is a known antipsychotic medication with partial agonist activity at the 5-HT1A receptor, which is beneficial in treating types of depression and bipolar disorder.

Cited Sources

1. US9125939B2 - Carbostyril derivatives and mood stabilizers for treating mood disorders - Google Patents
2. ANDA 090165 ANDA APPROVAL Zydus Pharmaceuticals (USA) Inc. - FDA
3. Patent Claims and Patent Scope - SSRN
4. Digital Pills with Ingestible Sensors: Patent Landscape Analysis - MDPI

Drugs Protected by US Patent 9,125,939

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-002	Jun 7, 2006		DISCN	Yes	No						ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-003	Jun 7, 2006		DISCN	Yes	No						ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-006	Nov 15, 2002	AB	RX	Yes	No						ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-005	Nov 15, 2002	AB	RX	Yes	No						ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER

Foreign Priority and PCT Information for Patent: 9,125,939

PCT Information
PCT Filed	May 19, 2004	PCT Application Number:	PCT/US2004/013308
PCT Publication Date:	December 09, 2004	PCT Publication Number:	WO2004/105682

International Family Members for US Patent 9,125,939

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004243096
Brazil	PI0410786
Canada	2526562
China	102000336