FDA Orange Book
Is there a generic for Prialt?
Prialt contains ziconotide acetate. 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 Prialt (ziconotide acetate).
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Prialt products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intrathecal | 100MCG/1ML (100MCG/ML) | Marketed (Rx) | None | 0 | None |
| injectable, intrathecal | 200MCG/2ML (100MCG/ML) | Discontinued | None | 0 | None |
| injectable, intrathecal | 500MCG/20ML (25MCG/ML) | Marketed (Rx) | None | 0 | None |
| injectable, intrathecal | 500MCG/5ML (100MCG/ML) | Marketed (Rx) | None | 0 | None |
NDA 021060, held by ESTEVE PHARMACEUTICALS SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Prialt NDC codes
Questions
Is there a generic for Prialt?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Prialt (ziconotide acetate).
What is the generic name for Prialt?
The active ingredient in Prialt is ziconotide acetate, 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.