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Details for Generic Name: aripiprazole

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Aripiprazole is the generic ingredient in one branded drug marketed by Otsuka Pharm Co Ltd and Otsuka, and is included in four NDAs. There are nineteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: aripiprazole

Drug Master File Entries: see list36
Suppliers: see list15
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: aripiprazole

Tentative approvals for ARIPIPRAZOLE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL2MG
<disabled><disabled>TABLET; ORAL5MG
<disabled><disabled>TABLET; ORAL10MG

Clinical Trials for: aripiprazole

Aripiprazole and Topiramate on Free-Choice Alcohol Use
Status: Recruiting 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

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

Aripiprazole in Adolescents With Schizophrenia
Status: Completed Condition: Schizophrenia

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
TABLET, ORALLY DISINTEGRATING; ORAL021729-005Jun 7, 2006RXYes<disabled><disabled>
TABLET, ORALLY DISINTEGRATING; ORAL021729-004Jun 7, 2006RXNo<disabled><disabled>
TABLET; ORAL021436-006Nov 15, 2002RXNo<disabled><disabled>
TABLET; ORAL021436-003Nov 15, 2002RXNo<disabled><disabled>
SOLUTION; ORAL021713-001Dec 10, 2004RXYes<disabled><disabled>
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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.

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Copyright 2002-2015 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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