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Details for Generic Name: aripiprazole

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Aripiprazole is the generic ingredient in four branded drugs marketed by Otsuka Pharm Co Ltd, Otsuka, Amneal Pharms, Apotex Inc, Silarx Pharms Inc, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Teva Pharms Usa, Torrent Pharms Ltd, and Alkermes Inc, and is included in eighteen NDAs. There are twenty-five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and seventy-two patent family members in thirty-five countries.

There are thirty-nine drug master file entries for aripiprazole. Fifteen suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: aripiprazole

Tradenames:4
Patents:25
Applicants:11
NDAs:18
Drug Master File Entries: see list39
Suppliers / Packaging: see list80
Therapeutic Class:Antipsychotics
Bipolar Agents

Pharmacology for Ingredient: aripiprazole

Tentative approvals for ARIPIPRAZOLE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL10MG
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL15MG
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL20MG

Clinical Trials for: aripiprazole

Aripiprazole and Topiramate on Free-Choice Alcohol Use
Status: Completed Condition: Alcohol Dependence

Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Status: Completed Condition: Schizophrenia

A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot
Status: Completed Condition: Schizophrenia

Safety and Efficacy of Aripiprazole and Ziprasidone Among Schizophrenic Patients With Metabolic Syndrome
Status: Completed Condition: Schizophrenia

Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Status: Completed Condition: Tourette's Disorder

Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals
Status: Completed Condition: Substance Abuse; HIV Infections

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 2014RXNo5,006,528*PED<disabled>Y<disabled>
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-002Nov 15, 2002RXNo<disabled><disabled>
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 2002RXYes9,125,939<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: aripiprazole

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 20025,006,528*PED<disabled>
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 20145,006,528*PED<disabled>
Otsuka
ABILIFY
aripiprazole
INJECTABLE;INTRAMUSCULAR021866-001Sep 20, 20065,006,528*PED<disabled>
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International Patent Family for Ingredient: aripiprazole

Country Document Number Publication Date
Russian Federation2005140285Jun 10, 2006
European Patent Office1927357May 12, 2010
Hong Kong1101550Sep 16, 2011
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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