Orange Book product · Brand (NDA)
ARISTADA INITIO KIT
ARIPIPRAZOLE LAUROXIL
At a glance
Jun 29, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 29, 2018
8 yr 1 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 10688091 expires
Listed drug product patent expiration.
Aug 17, 2035
in 9 yr 4 mo
Patent 10849894 expires
Listed method-of-use patent (U-543) expiration.
Aug 17, 2035
in 9 yr 4 mo
Patent 11154552 expires
Listed drug product patent expiration.
Aug 17, 2035
in 9 yr 4 mo
Patent 10016415 expires
Listed drug product patent expiration.
Sep 08, 2035
in 9 yr 4 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
675MG/2.4ML (281.25MG/ML)
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 209830
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 (9)
| 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 |
| 10688091 | Aug 17, 2035 | in 9 yr 4 mo | Product |
| 10849894 | Aug 17, 2035 | in 9 yr 4 mo | U-543 |
| 11154552 | Aug 17, 2035 | in 9 yr 4 mo | Product |
| 10016415 | Sep 08, 2035 | in 9 yr 4 mo | Product |
| 11273158 | Apr 06, 2039 | in 13 yr | U-543 |
| 12251381 | Apr 06, 2039 | in 13 yr | U-543 |

