FDA Orange Book
Is there a generic for Abilify Maintena Kit?
Abilify Maintena Kit contains aripiprazole. 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 Abilify Maintena Kit (aripiprazole). The Orange Book shows its last listed patent expires April 1, 2041.
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Abilify Maintena Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, extended release, intramuscular | 300MG | Marketed (Rx) | None | 0 | None |
| for suspension, extended release, intramuscular | 300MG/VIAL | Marketed (Rx) | None | 0 | None |
| for suspension, extended release, intramuscular | 400MG | Marketed (Rx) | None | 0 | None |
| for suspension, extended release, intramuscular | 400MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 202971, held by OTSUKA PHARMACEUTICAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Abilify Maintena Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11344547 | September 24, 2033 | Method of use | U-1632 | 202971 |
| 11400087 | September 24, 2033 | Method of use | U-3245 | 202971 |
| 11400087 | September 24, 2033 | Method of use | U-814 | 202971 |
| 11400087 | September 24, 2033 | Method of use | U-1632 | 202971 |
| 11344547 | September 24, 2033 | Method of use | U-3245 | 202971 |
| 11344547 | September 24, 2033 | Method of use | U-814 | 202971 |
| 10980803 | September 24, 2033 | Method of use | U-543 | 202971 |
| 10980803 | September 24, 2033 | Method of use | U-1632 | 202971 |
| 11154553 | September 24, 2033 | Method of use | U-1632 | 202971 |
| 11154553 | September 24, 2033 | Method of use | U-814 | 202971 |
| 11154553 | September 24, 2033 | Method of use | U-3245 | 202971 |
| 10525057 | March 8, 2034 | Method of use | U-543 | 202971 |
| 10525057 | March 8, 2034 | Method of use | U-1632 | 202971 |
| 10525057 | March 8, 2034 | Method of use | U-2723 | 202971 |
| 11648347 | April 6, 2034 | Drug product | None | 202971 |
| 12691056 | April 1, 2041 | Method of use | U-814 | 202971 |
| 12691056 | April 1, 2041 | Method of use | U-3245 | 202971 |
Questions
Is there a generic for Abilify Maintena Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Abilify Maintena Kit (aripiprazole). The Orange Book shows its last listed patent expires April 1, 2041.
What is the generic name for Abilify Maintena Kit?
The active ingredient in Abilify Maintena Kit is aripiprazole, per the FDA Orange Book.
When does the Abilify Maintena Kit patent expire?
The last patent listed for Abilify Maintena Kit in the Orange Book expires April 1, 2041. 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.