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Argus Health
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Generated: May 23, 2018

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 ten suppliers. There are forty-nine 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-five drug master file entries for this compound. Forty-two 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
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021729
Medical Subject Heading (MeSH) Categories for 021729
Suppliers and Packaging for NDA: 021729
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729 NDA Otsuka America Pharmaceutical, Inc. 59148-640 N 59148-640-23
ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729 NDA Otsuka America Pharmaceutical, Inc. 59148-641 N 59148-641-23

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ORALLY DISINTEGRATING;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No
Regulatory Exclusivity Expiration:Dec 12, 2021
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S
Patent:➤ Try a Free TrialPatent Expiration:Jan 28, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:➤ Try a Free 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 021729-002 Jun 7, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-005 Jun 7, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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