FDA Orange Book
Is there a generic for Aristada?
Aristada 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 (aripiprazole lauroxil). The Orange Book shows its last listed patent expires April 6, 2039.
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Aristada products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, extended release, intramuscular | 1064MG/3.9ML (272.82MG/ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, intramuscular | 441MG/1.6ML (275.63MG/ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, intramuscular | 662MG/2.4ML (275.83MG/ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, intramuscular | 882MG/3.2ML (275.63MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 207533, 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 patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10112903 | June 24, 2030 | Drug substance | U-543 | 207533 |
| 8796276 | June 24, 2030 | Method of use | U-543 | 207533 |
| 8431576 | October 26, 2030 | Drug substance | None | 207533 |
| 10226458 | March 19, 2032 | Method of use | U-543 | 207533 |
| 9034867 | November 7, 2032 | Drug product | U-543 | 207533 |
| 12629366 | December 6, 2032 | Drug product | U-764 | 207533 |
| 11097006 | September 19, 2033 | Drug product | U-764 | 207533 |
| 12311027 | September 19, 2033 | Drug product | U-543 | 207533 |
| 9193685 | October 24, 2033 | Drug product | U-543 | 207533 |
| 11969469 | April 6, 2034 | Drug product | None | 207533 |
| 10238651 | March 19, 2035 | Method of use | U-2402 | 207533 |
| 9452131 | March 19, 2035 | Method of use | U-2402 | 207533 |
| 10813928 | March 19, 2035 | Method of use | U-2983 | 207533 |
| 11406632 | March 19, 2035 | Method of use | U-2402 | 207533 |
| 12653822 | March 19, 2035 | Method of use | U-2402 | 207533 |
| 9526726 | March 19, 2035 | Drug product | None | 207533 |
| 10813928 | March 19, 2035 | Method of use | U-2402 | 207533 |
| 12251381 | April 6, 2039 | Method of use | U-543 | 207533 |
| 11273158 | April 6, 2039 | Method of use | U-543 | 207533 |
Aristada NDC codes
Questions
Is there a generic for Aristada?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Aristada (aripiprazole lauroxil). The Orange Book shows its last listed patent expires April 6, 2039.
What is the generic name for Aristada?
The active ingredient in Aristada is aripiprazole lauroxil, per the FDA Orange Book.
When does the Aristada patent expire?
The last patent listed for Aristada 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.
More on Aristada and Aripiprazole Lauroxil
- What is Aristada used for?FDA label uses
- Is Aristada a controlled substance?Federal schedule
- Generic for Aristada Initio KitFDA Orange Book
- Atypical Antipsychotics listFDA drug class
- Aristada Medicare Part D coverageBy plan and state
- NDC 65757-401Aristada NDC record
- NDC 65757-402Aristada NDC record
- NDC 65757-403Aristada NDC record