FDA Orange Book
Is there a generic for Aristada Initio Kit?
Aristada Initio Kit contains aripiprazole lauroxil. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Aristada Initio Kit (aripiprazole lauroxil). The Orange Book shows its last listed patent expires April 6, 2039.
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Aristada Initio Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, extended release, intramuscular | 675MG/2.4ML (281.25MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 209830, held by ALKERMES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Aristada Initio Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8796276 | June 24, 2030 | Method of use | U-543 | 209830 |
| 10112903 | June 24, 2030 | Drug substance | U-543 | 209830 |
| 8431576 | October 26, 2030 | Drug substance | None | 209830 |
| 10849894 | August 17, 2035 | Method of use | U-543 | 209830 |
| 11154552 | August 17, 2035 | Drug product | None | 209830 |
| 10688091 | August 17, 2035 | Drug product | None | 209830 |
| 10016415 | September 8, 2035 | Drug product | None | 209830 |
| 12251381 | April 6, 2039 | Method of use | U-543 | 209830 |
| 11273158 | April 6, 2039 | Method of use | U-543 | 209830 |
Aristada Initio Kit NDC codes
Questions
Is there a generic for Aristada Initio Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Aristada Initio Kit (aripiprazole lauroxil). The Orange Book shows its last listed patent expires April 6, 2039.
What is the generic name for Aristada Initio Kit?
The active ingredient in Aristada Initio Kit is aripiprazole lauroxil, per the FDA Orange Book.
When does the Aristada Initio Kit patent expire?
The last patent listed for Aristada Initio Kit in the Orange Book expires April 6, 2039. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.