Last Updated: September 24, 2026

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 thirty-seven 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 is one drug master file entry for this compound. Fifty 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:	2

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:	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 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Nov 15, 2002	TE:	AB	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 021436

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-004	Nov 15, 2002	7,053,092	⤷ Start Trial
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-004	Nov 15, 2002	4,734,416	⤷ Start Trial
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-002	Nov 15, 2002	9,387,182	⤷ Start Trial
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-005	Nov 15, 2002	7,053,092	⤷ Start Trial
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-006	Nov 15, 2002	4,734,416	⤷ Start Trial
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-001	Nov 15, 2002	9,089,567	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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