Last Updated: September 24, 2026

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 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 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DISCN	Dosage:	SOLUTION;ORAL			Strength	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	⤷ Start Trial	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	⤷ Start Trial	⤷ Start Trial
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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