FDA Orange Book
Is there a generic for Versacloz?
Versacloz contains clozapine. 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 Versacloz (clozapine). The Orange Book shows its last listed patent expires May 1, 2028.
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Versacloz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 50MG/ML | Marketed (Rx) | None | 0 | None |
NDA 203479, held by DOUGLAS PHARMACEUTICALS AMERICA LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Versacloz patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8057811 | May 1, 2028 | Drug product | None | 203479 |
Versacloz NDC codes
Questions
Is there a generic for Versacloz?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Versacloz (clozapine). The Orange Book shows its last listed patent expires May 1, 2028.
What is the generic name for Versacloz?
The active ingredient in Versacloz is clozapine, per the FDA Orange Book.
When does the Versacloz patent expire?
The last patent listed for Versacloz in the Orange Book expires May 1, 2028. 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.