FDA Orange Book
Generic for Orap
Orap contains pimozide. 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
Yes. The generic name for Orap is pimozide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Orap products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Discontinued | None | 2 | AB |
| tablet, oral | 2MG | Discontinued | None | 2 | AB |
NDA 017473, held by TEVA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pimozide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 204521 | AB (A-rated, therapeutically equivalent) | September 28, 2015 | 1MG, 2MG |
| NOVITIUM PHARMA LLC | 219897 | AB (A-rated, therapeutically equivalent) | April 13, 2026 | 1MG, 2MG |
Questions
Is there a generic for Orap?
Yes. The generic name for Orap is pimozide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Orap?
The active ingredient in Orap is pimozide, per the FDA Orange Book.
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.