Orange Book product · Brand (NDA)
ARISTADA
ARIPIPRAZOLE LAUROXIL
At a glance
Oct 05, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
15
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 05, 2015
10 yr 10 mo ago
Today
Patent 10112903 expires
Listed drug substance patent expiration.
Jun 24, 2030
in 4 yr 1 mo
Patent 8796276 expires
Listed method-of-use patent (U-543) expiration.
Jun 24, 2030
in 4 yr 1 mo
Patent 8431576 expires
Listed drug substance patent expiration.
Oct 26, 2030
in 4 yr 5 mo
Patent 10226458 expires
Listed method-of-use patent (U-543) expiration.
Mar 19, 2032
in 5 yr 10 mo
Patent 9034867 expires
Listed drug product patent expiration.
Nov 07, 2032
in 6 yr 6 mo
Patent 12311027 expires
Listed drug product patent expiration.
Sep 19, 2033
in 7 yr 4 mo
Patent 11097006 expires
Listed drug product patent expiration.
Oct 24, 2033
in 7 yr 5 mo
Patent 11969469 expires
Listed drug product patent expiration.
Oct 24, 2033
in 7 yr 5 mo
Patent 9193685 expires
Listed drug product patent expiration.
Oct 24, 2033
in 7 yr 5 mo
Patent 10238651 expires
Listed method-of-use patent (U-2402) expiration.
Mar 19, 2035
in 8 yr 11 mo
Patent 10813928 expires
Listed method-of-use patent (U-2983) expiration.
Mar 19, 2035
in 8 yr 11 mo
Patent 11406632 expires
Listed method-of-use patent (U-2402) expiration.
Mar 19, 2035
in 8 yr 11 mo
Patent 9452131 expires
Listed method-of-use patent (U-2402) expiration.
Mar 19, 2035
in 8 yr 11 mo
Patent 11273158 expires
Listed method-of-use patent (U-543) expiration.
Apr 06, 2039
in 13 yr
Patent 12251381 expires
Listed method-of-use patent (U-543) expiration.
Apr 06, 2039
in 13 yr
Pharmaceutical detail
Active ingredient
ARIPIPRAZOLE LAUROXIL
Strength
441MG/1.6ML (275.63MG/ML)
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 207533
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.
Listed patents (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10112903 | Jun 24, 2030 | in 4 yr 1 mo | SubstanceU-543 |
| 8796276 | Jun 24, 2030 | in 4 yr 1 mo | U-543 |
| 8431576 | Oct 26, 2030 | in 4 yr 5 mo | Substance |
| 10226458 | Mar 19, 2032 | in 5 yr 10 mo | U-543 |
| 9034867 | Nov 07, 2032 | in 6 yr 6 mo | ProductU-543 |
| 12311027 | Sep 19, 2033 | in 7 yr 4 mo | ProductU-543 |
| 11097006 | Oct 24, 2033 | in 7 yr 5 mo | ProductU-764 |
| 11969469 | Oct 24, 2033 | in 7 yr 5 mo | Product |
| 9193685 | Oct 24, 2033 | in 7 yr 5 mo | ProductU-543 |
| 10238651 | Mar 19, 2035 | in 8 yr 11 mo | U-2402 |
| 10813928 | Mar 19, 2035 | in 8 yr 11 mo | U-2983 |
| 11406632 | Mar 19, 2035 | in 8 yr 11 mo | U-2402 |
| 9452131 | Mar 19, 2035 | in 8 yr 11 mo | U-2402 |
| 11273158 | Apr 06, 2039 | in 13 yr | U-543 |
| 12251381 | Apr 06, 2039 | in 13 yr | U-543 |
