Orange Book product · Brand (NDA)
ABILIFY
ARIPIPRAZOLE
At a glance
Nov 15, 2002
Approved
Brand (NDA)
Application
AB
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 15, 2002
23 yr 11 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
Pharmaceutical detail
Active ingredient
ARIPIPRAZOLE
Strength
2MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021436
Product number
006
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025MEZOFYBrand (NDA)
NDA 211448 · CMG PHARM CO LTD
- 2024OPIPZABrand (NDA)
NDA 216655 · XIAMEN LP PHARM CO
- 2023ABILIFY ASIMTUFIIBrand (NDA)
NDA 217006 · OTSUKA
- 2017ABILIFY MYCITE KITBrand (NDA)
NDA 207202 · OTSUKA
- 2013ABILIFY MAINTENA KITBrand (NDA)
NDA 202971 · OTSUKA PHARM CO LTD
- 2006ABILIFYBrand (NDA)
NDA 021866 · OTSUKA
- 2006ABILIFYBrand (NDA)
NDA 021729 · OTSUKA
- 2004ABILIFYBrand (NDA)
NDA 021713 · OTSUKA
- 2026ARIPIPRAZOLEGeneric (ANDA)
ANDA 216208 · AUROBINDO PHARMA
- 2025ARIPIPRAZOLEGeneric (ANDA)
ANDA 215582 · QUAGEN
- 2024ARIPIPRAZOLEGeneric (ANDA)
ANDA 216608 · MYLAN
- 2024ARIPIPRAZOLEGeneric (ANDA)
ANDA 205589 · LUPIN
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9125939 | Jul 28, 2026 | in 1 mo | U-1749 |
| 8759350 | Mar 02, 2027 | in 9 mo | U-1529 |
