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Last Updated: July 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021729


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NDA 021729 describes ABILIFY, which is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. It is available from two suppliers. There are fifty patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ABILIFY profile page.

The generic ingredient in ABILIFY is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 021729
Tradename:ABILIFY
Applicant:Otsuka
Ingredient:aripiprazole
Patents:12
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021729
Paragraph IV (Patent) Challenges for 021729
Tradename Dosage Ingredient NDA Submissiondate
ABILIFY TABLET, ORALLY DISINTEGRATING;ORAL aripiprazole 021729 2006-11-15

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 7, 2006TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 12, 2021
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S
Patent:  Start TrialPatent Expiration:Jan 28, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:  Start TrialPatent Expiration:Dec 16, 2024Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021729

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-002 Jun 7, 2006   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-005 Jun 7, 2006   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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