Details for New Drug Application (NDA): 021729

NDA 021729 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-one 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 021729

Tradename:	ABILIFY
Applicant:	Otsuka
Ingredient:	aripiprazole
Patents:	2

Medical Subject Heading (MeSH) Categories for 021729

Antipsychotic Agents

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Jun 7, 2006	TE:		RLD:	Yes
Patent:	8,759,350	Patent Expiration:	Mar 2, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:	9,125,939	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

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Jun 7, 2006	TE:		RLD:	Yes
Patent:	8,759,350	Patent Expiration:	Mar 2, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

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	021729-005	Jun 7, 2006	9,359,302
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-002	Jun 7, 2006	8,642,760*PED
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-004	Jun 7, 2006	8,017,615*PED
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-005	Jun 7, 2006	8,642,600*PED
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-003	Jun 7, 2006	9,387,182
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-002	Jun 7, 2006	5,006,528*PED
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-003	Jun 7, 2006	5,006,528*PED

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