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Last Updated: July 12, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207202


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NDA 207202 describes ABILIFY MYCITE KIT, which is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier. There are thirty-two patents protecting this drug. Additional details are available on the ABILIFY MYCITE KIT profile page.

The generic ingredient in ABILIFY MYCITE KIT 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 207202
Tradename:ABILIFY MYCITE KIT
Applicant:Otsuka Pharm Co Ltd
Ingredient:aripiprazole
Patents:32
Formulation / Manufacturing:see details
Pharmacology for NDA: 207202
Medical Subject Heading (MeSH) Categories for 207202
Suppliers and Packaging for NDA: 207202
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202 NDA Otsuka America Pharmaceutical, Inc. 59148-029 59148-029-85 1 BOTTLE in 1 KIT (59148-029-85) > 30 TABLET in 1 BOTTLE (59148-029-13)
ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202 NDA Otsuka America Pharmaceutical, Inc. 59148-029 59148-029-90 1 BOTTLE in 1 CARTON (59148-029-90) > 30 TABLET in 1 BOTTLE (59148-029-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Nov 13, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 27, 2020
Regulatory Exclusivity Use:NEW INDICATION OF MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER IN ADULTS
Patent:  Start TrialPatent Expiration:Jul 26, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 13, 2032Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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