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Last Updated: December 12, 2025

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 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 021713

Tradename:	ABILIFY
Applicant:	Otsuka
Ingredient:	aripiprazole
Patents:	1

Medical Subject Heading (MeSH) Categories for 021713

Antipsychotic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 10, 2004	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 021713

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004	5,006,528*PED	⤷ Get Started Free
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004	8,642,600*PED	⤷ Get Started Free
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004	9,387,182	⤷ Get Started Free
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004	7,053,092	⤷ Get Started Free
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004	6,977,257*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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