Orange Book product · Brand (NDA)
ABILIFY ASIMTUFII
ARIPIPRAZOLE
At a glance
Apr 27, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 27, 2023
3 yr 2 mo ago
Today
Patent 10517951 expires
Listed drug product patent expiration.
Apr 23, 2033
in 6 yr 11 mo
Patent 10517951 expires
Listed drug product patent expiration.
Apr 23, 2033
in 6 yr 11 mo
Patent 11097007 expires
Listed drug product patent expiration.
Apr 23, 2033
in 6 yr 11 mo
Patent 11097007 expires
Listed drug product patent expiration.
Apr 23, 2033
in 6 yr 11 mo
Patent 11638757 expires
Listed drug product patent expiration.
Apr 23, 2033
in 6 yr 11 mo
Patent 11638757 expires
Listed drug product patent expiration.
Apr 23, 2033
in 6 yr 11 mo
Patent 12016927 expires
Listed drug product patent expiration.
Apr 23, 2033
in 6 yr 11 mo
Patent 12016927 expires
Listed drug product patent expiration.
Apr 23, 2033
in 6 yr 11 mo
Pharmaceutical detail
Active ingredient
ARIPIPRAZOLE
Strength
720MG/2.4ML (300MG/ML)
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 217006
Product number
001
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
- 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
- 2002ABILIFYBrand (NDA)
NDA 021436 · OTSUKA
- 2026ARIPIPRAZOLEGeneric (ANDA)
ANDA 216208 · AUROBINDO PHARMA
- 2025ARIPIPRAZOLEGeneric (ANDA)
ANDA 215582 · QUAGEN
- 2024ARIPIPRAZOLEGeneric (ANDA)
ANDA 216608 · MYLAN
- 2024ARIPIPRAZOLEGeneric (ANDA)
ANDA 205589 · LUPIN
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10517951 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-3245 |
| 10517951 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-814 |
| 11097007 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-3245 |
| 11097007 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-814 |
| 11638757 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-3245 |
| 11638757 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-814 |
| 12016927 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-3245 |
| 12016927 | Apr 23, 2033 | in 6 yr 11 mo | ProductU-543 |
