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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Baxter
Accenture
US Department of Justice
Cerilliant
Fish and Richardson
Novartis
QuintilesIMS
Fuji
UBS

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021713

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NDA 021713 describes ABILIFY, which is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in five NDAs. It is available from thirteen 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-four drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 021713
Tradename:ABILIFY
Applicant:Otsuka
Ingredient:aripiprazole
Patents:5
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021713
Medical Subject Heading (MeSH) Categories for 021713
Suppliers and Packaging for NDA: 021713
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABILIFY aripiprazole SOLUTION;ORAL 021713 NDA Otsuka America Pharmaceutical, Inc. 59148-013 59148-013-15 150 mL in 1 BOTTLE (59148-013-15)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 10, 2004TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 9, 2017
Regulatory Exclusivity Use:LABELING REVISIONS RESULTING FROM A MAINTENANCE TRIAL IN PEDIATRIC PATIENTS WITH IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
Regulatory Exclusivity Expiration:Dec 12, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Dec 12, 2017
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S DISORDER (6-18 YEARS)

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Serving leading biopharmaceutical companies globally:

Express Scripts
Chubb
Queensland Health
Teva
Merck
US Department of Justice
McKinsey
AstraZeneca
QuintilesIMS

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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