FDA Orange Book
Is there a generic for Opipza?
Opipza 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 Opipza (aripiprazole). The Orange Book shows its last listed patent expires December 15, 2041.
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Opipza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, oral | 10MG | Marketed (Rx) | None | 0 | None |
| film, oral | 2MG | Marketed (Rx) | None | 0 | None |
| film, oral | 5MG | Marketed (Rx) | None | 0 | None |
NDA 216655, held by XIAMEN LP PHARMACUETICAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Opipza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11331315 | November 3, 2040 | Drug product | None | 216655 |
| 11701352 | December 15, 2041 | Drug product | None | 216655 |
Opipza NDC codes
Questions
Is there a generic for Opipza?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Opipza (aripiprazole). The Orange Book shows its last listed patent expires December 15, 2041.
What is the generic name for Opipza?
The active ingredient in Opipza is aripiprazole, per the FDA Orange Book.
When does the Opipza patent expire?
The last patent listed for Opipza in the Orange Book expires December 15, 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.
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