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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

Tradenames:1
Patents:3
Applicants:1
NDAs:4
Drug Master File Entries: see list36
Suppliers: see list15
Therapeutic Class:Antipsychotics
Bipolar Agents

Pharmacology for Ingredient: aripiprazole

Tentative approvals for ARIPIPRAZOLE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL5MG
<disabled><disabled>TABLET; ORAL10MG
<disabled><disabled>TABLET; ORAL15MG

Clinical Trials for: aripiprazole

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

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

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

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

Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects
Status: Completed Condition: Pharmacokinetics; Cytochrome P-450 CYP2D6; CYP3A4 Protein, Human

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
Otsuka
ABILIFY
aripiprazole
TABLET; ORAL021436Nov 15, 2002RXYes5,006,528<disabled><disabled>
Otsuka
ABILIFY
aripiprazole
TABLET; ORAL021436Nov 15, 2002RXNo<disabled><disabled>
Otsuka
ABILIFY
aripiprazole
TABLET; ORAL021436Nov 15, 2002RXNo5,006,528<disabled><disabled>
Otsuka
ABILIFY
aripiprazole
TABLET; ORAL021436Nov 15, 2002RXYes<disabled><disabled>
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING; ORAL021729Jun 7, 2006RXYes<disabled><disabled>
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