FDA Orange Book
Is there a generic for Zonisade?
Zonisade contains zonisamide. 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 Zonisade (zonisamide). The Orange Book shows its last listed patent expires August 18, 2038.
Run it in Rivvi
Map Zonisade and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Zonisade products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 100MG/5ML | Marketed (Rx) | None | 0 | None |
NDA 214273, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zonisade patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11478456 | August 18, 2038 | Method of use | U-3458 | 214273 |
| 12491179 | August 18, 2038 | Drug product | None | 214273 |
| 12685723 | August 18, 2038 | Drug product | None | 214273 |
| 11529333 | August 18, 2038 | Drug product | None | 214273 |
Zonisade NDC codes
Questions
Is there a generic for Zonisade?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zonisade (zonisamide). The Orange Book shows its last listed patent expires August 18, 2038.
What is the generic name for Zonisade?
The active ingredient in Zonisade is zonisamide, per the FDA Orange Book.
When does the Zonisade patent expire?
The last patent listed for Zonisade in the Orange Book expires August 18, 2038. 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.