FDA Orange Book
Is there a generic for Sezaby?
Sezaby contains phenobarbital. 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 Sezaby (phenobarbital). The Orange Book shows its last listed patent expires April 7, 2042 and its last listed exclusivity ends November 17, 2029.
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Sezaby products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 100MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 215910, held by SUN PHARMACEUTICAL INDUSTRIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sezaby patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11857683 | April 7, 2042 | Drug product | U-3779 | 215910 |
| 12636254 | April 7, 2042 | Drug product | U-3779 | 215910 |
Sezaby exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-414 | Orphan drug exclusivity | November 17, 2029 | 215910 |
Sezaby NDC codes
Questions
Is there a generic for Sezaby?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sezaby (phenobarbital). The Orange Book shows its last listed patent expires April 7, 2042 and its last listed exclusivity ends November 17, 2029.
What is the generic name for Sezaby?
The active ingredient in Sezaby is phenobarbital, per the FDA Orange Book.
When does the Sezaby patent expire?
The last patent listed for Sezaby in the Orange Book expires April 7, 2042. 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.