Orange Book product · Brand (NDA)
ABILIFY MYCITE KIT
ARIPIPRAZOLE
At a glance
Nov 13, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
27
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 13, 2017
8 yr 9 mo ago
Patent 11476952 expires
Listed drug product patent expiration.
Apr 28, 2026
2 mo ago
Today
Patent 9125939 expires
Listed method-of-use patent (U-1749) expiration.
Jul 28, 2026
in 1 mo
Patent 7978064 expires
Listed drug product patent expiration.
Sep 14, 2026
in 3 mo
Patent 8759350 expires
Listed method-of-use patent (U-1529) expiration.
Mar 02, 2027
in 9 mo
Patent 9444503 expires
Listed drug product patent expiration.
Nov 19, 2027
in 1 yr 5 mo
Patent 9119554 expires
Listed drug product patent expiration.
Dec 16, 2028
in 2 yr 6 mo
Patent 9060708 expires
Listed drug product patent expiration.
Mar 05, 2029
in 2 yr 9 mo
Patent 9258035 expires
Listed drug product patent expiration.
Mar 05, 2029
in 2 yr 9 mo
Patent 8674825 expires
Listed drug product patent expiration.
Apr 09, 2029
in 2 yr 10 mo
Patent 8956288 expires
Listed drug product patent expiration.
Jul 06, 2029
in 3 yr 1 mo
Patent 10441194 expires
Listed drug product patent expiration.
Jul 26, 2029
in 3 yr 2 mo
Patent 8945005 expires
Listed drug product patent expiration.
Aug 19, 2029
in 3 yr 3 mo
Patent 9433371 expires
Listed drug product patent expiration.
Sep 15, 2029
in 3 yr 3 mo
Patent 8718193 expires
Listed drug product patent expiration.
Dec 05, 2029
in 3 yr 6 mo
Patent 9149577 expires
Listed drug product patent expiration.
Dec 15, 2029
in 3 yr 7 mo
Patent 8847766 expires
Listed drug product patent expiration.
Mar 29, 2030
in 3 yr 10 mo
Patent 8545402 expires
Listed drug product patent expiration.
Apr 27, 2030
in 3 yr 11 mo
Patent 8114021 expires
Listed drug product patent expiration.
Jun 21, 2030
in 4 yr 1 mo
Patent 11464423 expires
Listed drug product patent expiration.
Sep 15, 2030
in 4 yr 4 mo
Patent 9941931 expires
Listed drug product patent expiration.
Nov 04, 2030
in 4 yr 5 mo
Patent 8961412 expires
Listed drug product patent expiration.
Nov 17, 2030
in 4 yr 6 mo
Patent 8258962 expires
Listed drug product patent expiration.
Nov 25, 2030
in 4 yr 6 mo
Patent 8547248 expires
Listed drug product patent expiration.
Dec 18, 2030
in 4 yr 7 mo
Patent 11229378 expires
Listed drug product patent expiration.
Jul 11, 2031
in 5 yr 2 mo
Patent 9320455 expires
Listed drug product patent expiration.
Dec 15, 2031
in 5 yr 7 mo
Patent 10517507 expires
Listed drug product patent expiration.
Jun 13, 2032
in 6 yr 1 mo
Patent 9268909 expires
Listed drug product patent expiration.
Oct 15, 2033
in 7 yr 5 mo
Pharmaceutical detail
Active ingredient
ARIPIPRAZOLE
Strength
2MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 207202
Product number
001
Marketing status
DISCN
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
- 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 (27)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11476952 | Apr 28, 2026 | 2 mo ago | Product |
| 9125939 | Jul 28, 2026 | in 1 mo | U-1749 |
| 7978064 | Sep 14, 2026 | in 3 mo | Product |
| 8759350 | Mar 02, 2027 | in 9 mo | U-1529 |
| 9444503 | Nov 19, 2027 | in 1 yr 5 mo | ProductU-2169 |
| 9119554 | Dec 16, 2028 | in 2 yr 6 mo | Product |
| 9060708 | Mar 05, 2029 | in 2 yr 9 mo | Product |
| 9258035 | Mar 05, 2029 | in 2 yr 9 mo | Product |
| 8674825 | Apr 09, 2029 | in 2 yr 10 mo | ProductU-2170 |
| 8956288 | Jul 06, 2029 | in 3 yr 1 mo | ProductU-2167 |
| 10441194 | Jul 26, 2029 | in 3 yr 2 mo | Product |
| 8945005 | Aug 19, 2029 | in 3 yr 3 mo | ProductU-2167 |
| 9433371 | Sep 15, 2029 | in 3 yr 3 mo | Product |
| 8718193 | Dec 05, 2029 | in 3 yr 6 mo | Product |
| 9149577 | Dec 15, 2029 | in 3 yr 7 mo | Product |
| 8847766 | Mar 29, 2030 | in 3 yr 10 mo | ProductU-2167 |
| 8545402 | Apr 27, 2030 | in 3 yr 11 mo | Product |
| 8114021 | Jun 21, 2030 | in 4 yr 1 mo | Product |
| 11464423 | Sep 15, 2030 | in 4 yr 4 mo | Product |
| 9941931 | Nov 04, 2030 | in 4 yr 5 mo | Product |
| 8961412 | Nov 17, 2030 | in 4 yr 6 mo | Product |
| 8258962 | Nov 25, 2030 | in 4 yr 6 mo | Product |
| 8547248 | Dec 18, 2030 | in 4 yr 7 mo | ProductU-2167 |
| 11229378 | Jul 11, 2031 | in 5 yr 2 mo | Product |
| 9320455 | Dec 15, 2031 | in 5 yr 7 mo | Product |
| 10517507 | Jun 13, 2032 | in 6 yr 1 mo | Product |
| 9268909 | Oct 15, 2033 | in 7 yr 5 mo | ProductU-2168 |

