Details for New Drug Application (NDA): 021436

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NDA 021436 describes ABILIFY, which is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in seven NDAs. It is available from one supplier. There are forty-six 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-nine suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

Summary for 021436

Tradename:	ABILIFY
Applicant:	Otsuka
Ingredient:	aripiprazole
Patents:	3

Pharmacology for NDA: 021436

Medical Subject Heading (MeSH) Categories for 021436

Antipsychotic Agents

Suppliers and Packaging for NDA: 021436

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABILIFY	aripiprazole	TABLET;ORAL	021436	NDA	Otsuka America Pharmaceutical, Inc.	59148-006	59148-006-13	30 TABLET in 1 BOTTLE, PLASTIC (59148-006-13)
ABILIFY	aripiprazole	TABLET;ORAL	021436	NDA	Otsuka America Pharmaceutical, Inc.	59148-006	59148-006-92	7 TABLET in 1 BLISTER PACK (59148-006-92)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 15, 2002	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 16, 2024	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Mar 2, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:	⤷ Sign Up	Patent Expiration:	Jul 28, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER

Expired US Patents for NDA 021436

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-002	Nov 15, 2002	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-002	Nov 15, 2002	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-003	Nov 15, 2002	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-003	Nov 15, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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 verification 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.