Orange Book product · Brand (NDA)

ABILIFY

ARIPIPRAZOLE

Brand (NDA)NDA 021729DISCN OTSUKA

Jun 07, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 07, 2006
20 yr 4 mo ago
Today
Patent 9125939 expires
Listed method-of-use patent (U-1749) expiration.
Jul 28, 2026
in 1 mo
Patent 8759350 expires
Listed method-of-use patent (U-1529) expiration.
Mar 02, 2027
in 9 mo

Active ingredient

ARIPIPRAZOLE

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

TE code

Not listed

Application

NDA 021729

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9125939	Jul 28, 2026	in 1 mo	U-1749
8759350	Mar 02, 2027	in 9 mo	U-1529