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Last Updated: May 16, 2021

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 forty-eight 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-three 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:11
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ORALLY DISINTEGRATING;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:
Patent:  Get Started for $10Patent Expiration:Jan 28, 2022Product Flag?Substance Flag?Delist Request?
Patent:  Get Started for $10Patent 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 021729-003 Jun 7, 2006   Get Started for $10   Get Started for $10
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006   Get Started for $10   Get Started for $10
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-002 Jun 7, 2006   Get Started for $10   Get Started for $10
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-005 Jun 7, 2006   Get Started for $10   Get Started for $10
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006   Get Started for $10   Get Started for $10
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-005 Jun 7, 2006   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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