FDA Orange Book · active-ingredient family
Aripiprazole lauroxil
Aripiprazole lauroxil is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ARISTADA INITIO KIT · NDA 209830
2
Brand (NDA)
0
Generics (ANDA)
20
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ARISTADA INITIO KITRLD | ALKERMES INC | NDA 209830 | — | Jun 29, 2018 | |
| ARISTADARLD×4 | ALKERMES INC | NDA 207533 | — | Oct 05, 2015 |
Listed patents (20)
| 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 |
| 9193685 | Oct 24, 2033 | in 7 yr 5 mo | ProductU-543 |
| 11097006 | Oct 24, 2033 | in 7 yr 5 mo | ProductU-764 |
| 11969469 | Oct 24, 2033 | in 7 yr 5 mo | Product |
| 10238651 | Mar 19, 2035 | in 8 yr 11 mo | U-2402 |
| 9452131 | 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 |
| 9526726 | Mar 19, 2035 | in 8 yr 11 mo | Product |
| 10849894 | Aug 17, 2035 | in 9 yr 4 mo | U-543 |
| 11154552 | Aug 17, 2035 | in 9 yr 4 mo | Product |
| 10688091 | Aug 17, 2035 | in 9 yr 4 mo | Product |
| 10016415 | Sep 08, 2035 | in 9 yr 4 mo | Product |
| 12251381 | Apr 06, 2039 | in 13 yr | U-543 |
| 11273158 | Apr 06, 2039 | in 13 yr | U-543 |
Aripiprazole lauroxil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
