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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 twenty-one patents protecting this drug and three Paragraph IV challenges.

This drug has eigthy patent family members in thirty-two countries.

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

Summary for Tradename: ABILIFY

Suppliers / Packagers: see list76
2013 Sales:$6,460,215,000

Pharmacology for Tradename: ABILIFY

Clinical Trials for: ABILIFY

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

Comparative Bioavailability Study of Aripiprazole 10 mg Oral Soluble Film vs Abilify® 10 mg Tablet in Healthy Volunteers
Status: Active, not recruiting Condition: Schizophrenia

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

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

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

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

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

Courtesy of
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
TABLET;ORAL021436-006Nov 15, 2002RXNo<disabled><disabled>
TABLET;ORAL021436-002Nov 15, 2002RXNo8,017,615*PED<disabled>Y<disabled>
TABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 2006DISCNNo7,053,092<disabled> <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

International Patent Family for Tradename: ABILIFY

Country Document Number Publication Date
Hong Kong1145291Aug 01, 2014
European Patent Office1575590Oct 24, 2007
BrazilPI0410786Jun 20, 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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