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Profile for Tradename: ABILIFY

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Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in five NDAs. It is available from fifteen suppliers. There are nineteen patents protecting this drug and three Paragraph IV challenges.

The generic ingredient in ABILIFY is aripiprazole. There are thirty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the aripiprazole profile page.

Summary for Tradename: ABILIFY

Patents:19
Applicants:2
NDAs:5
Suppliers: see list15
2013 Sales:$6,460,215,000

Pharmacology for Tradename: ABILIFY

Clinical Trials for: ABILIFY

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

Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children
Status: Completed Condition: Autism

Abilify as an Adjunctive Treatment for Refractory Depression
Status: Completed Condition: Depressive Disorder, Major

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

Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
Status: Recruiting Condition: Major Depressive Disorder

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

A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy
Status: Completed Condition: Major Depressive Disorder

The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression
Status: Completed Condition: Psychotic Depression

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
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-004Nov 15, 2002RXNo<disabled><disabled>
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-002Nov 15, 2002RXNo<disabled><disabled>
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 2002RXNo8,642,760*PED<disabled>Y<disabled>
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-002Jun 7, 2006RXYes8,759,350<disabled><disabled>
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013RXYes7,807,680<disabled>Y<disabled>
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Paragraph IV activity for: ABILIFY

Drugname Dosage Strength RLD Submissiondate
aripiprazoleOral Solution1 mg/mLAbilify12/20/2007
aripiprazoleOrally Disintegrating Tablets10 mg, 15 mg, 20 mg and 30 mgAbilify11/15/2006
aripiprazoleTablets2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mgAbilify11/15/2006
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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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