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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 five NDAs. It is available from fourteen suppliers. There are twenty-three 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-two drug master file entries for this compound. Thirty-six suppliers are listed for this compound. There are sixteen tentative approvals for this compound. Additional details are available on the aripiprazole profile page.

Summary for NDA: 021729

Tradename:
ABILIFY
Applicant:
Otsuka
Ingredient:
aripiprazole
Patents:12
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 59148-640-23 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59148-640-23)
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL 021729 NDA Otsuka America Pharmaceutical, Inc. 59148-641 59148-641-23 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59148-641-23)

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Jun 7, 2006TE:RLD:No
Patent:8,017,615*PEDPatent Expiration:Dec 16, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:8,518,421*PEDPatent Expiration:Jul 24, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:8,580,796*PEDPatent Expiration:Mar 25, 2023Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021729

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-002Jun 7, 20065,006,528*PED► subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 20065,006,528*PED► subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 20065,006,528*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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