FDA Orange Book
Is there a generic for Abilify Asimtufii?
Abilify Asimtufii 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 Asimtufii (aripiprazole). The Orange Book shows its last listed patent expires April 23, 2033.
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Abilify Asimtufii products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, extended release, intramuscular | 720MG/2.4ML (300MG/ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, intramuscular | 960MG/3.2ML (300MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 217006, 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 Asimtufii patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12016927 | April 23, 2033 | Drug product | U-3245 | 217006 |
| 12016927 | April 23, 2033 | Drug product | U-543 | 217006 |
| 11638757 | April 23, 2033 | Drug product | U-3245 | 217006 |
| 11638757 | April 23, 2033 | Drug product | U-814 | 217006 |
| 11097007 | April 23, 2033 | Drug product | U-3245 | 217006 |
| 11097007 | April 23, 2033 | Drug product | U-814 | 217006 |
| 10517951 | April 23, 2033 | Drug product | U-3245 | 217006 |
| 10517951 | April 23, 2033 | Drug product | U-814 | 217006 |
Abilify Asimtufii NDC codes
Questions
Is there a generic for Abilify Asimtufii?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Abilify Asimtufii (aripiprazole). The Orange Book shows its last listed patent expires April 23, 2033.
What is the generic name for Abilify Asimtufii?
The active ingredient in Abilify Asimtufii is aripiprazole, per the FDA Orange Book.
When does the Abilify Asimtufii patent expire?
The last patent listed for Abilify Asimtufii in the Orange Book expires April 23, 2033. 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.
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