Orange Book product · Brand (NDA)
ABILIFY MAINTENA KIT
ARIPIPRAZOLE
At a glance
Feb 28, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
15
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 28, 2013
13 yr 6 mo ago
Today
Patent 10980803 expires
Listed method-of-use patent (U-543) expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 10980803 expires
Listed method-of-use patent (U-1632) expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 11154553 expires
Listed method-of-use patent (U-1632) expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 11154553 expires
Listed method-of-use patent (U-814) expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 11154553 expires
Listed method-of-use patent (U-3245) expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 11344547 expires
Listed method-of-use patent (U-1632) expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 11344547 expires
Listed method-of-use patent (U-3245) expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 11344547 expires
Listed method-of-use patent (U-814) expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 11400087 expires
Listed method-of-use patent (U-3245) expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 11400087 expires
Listed method-of-use patent (U-814) expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 11400087 expires
Listed method-of-use patent (U-1632) expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 10525057 expires
Listed method-of-use patent (U-543) expiration.
Mar 08, 2034
in 7 yr 10 mo
Patent 10525057 expires
Listed method-of-use patent (U-1632) expiration.
Mar 08, 2034
in 7 yr 10 mo
Patent 10525057 expires
Listed method-of-use patent (U-2723) expiration.
Mar 08, 2034
in 7 yr 10 mo
Patent 11648347 expires
Listed drug product patent expiration.
Apr 06, 2034
in 7 yr 11 mo
Pharmaceutical detail
Active ingredient
ARIPIPRAZOLE
Strength
300MG/VIAL
Dosage form
FOR SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 202971
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
- 2023ABILIFY ASIMTUFIIBrand (NDA)
NDA 217006 · OTSUKA
- 2017ABILIFY MYCITE KITBrand (NDA)
NDA 207202 · OTSUKA
- 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 (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10980803 | Sep 24, 2033 | in 7 yr 4 mo | U-543 |
| 10980803 | Sep 24, 2033 | in 7 yr 4 mo | U-1632 |
| 11154553 | Sep 24, 2033 | in 7 yr 4 mo | U-1632 |
| 11154553 | Sep 24, 2033 | in 7 yr 4 mo | U-814 |
| 11154553 | Sep 24, 2033 | in 7 yr 4 mo | U-3245 |
| 11344547 | Sep 24, 2033 | in 7 yr 4 mo | U-1632 |
| 11344547 | Sep 24, 2033 | in 7 yr 4 mo | U-3245 |
| 11344547 | Sep 24, 2033 | in 7 yr 4 mo | U-814 |
| 11400087 | Sep 24, 2033 | in 7 yr 4 mo | U-3245 |
| 11400087 | Sep 24, 2033 | in 7 yr 4 mo | U-814 |
| 11400087 | Sep 24, 2033 | in 7 yr 4 mo | U-1632 |
| 10525057 | Mar 08, 2034 | in 7 yr 10 mo | U-543 |
| 10525057 | Mar 08, 2034 | in 7 yr 10 mo | U-1632 |
| 10525057 | Mar 08, 2034 | in 7 yr 10 mo | U-2723 |
| 11648347 | Apr 06, 2034 | in 7 yr 11 mo | Product |
