FDA Orange Book
Is there a generic for Diacomit?
Diacomit contains stiripentol. 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 Diacomit (stiripentol). The Orange Book shows its last listed exclusivity ends July 14, 2029.
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Diacomit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 250MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 500MG | Marketed (Rx) | None | 0 | None |
| for suspension, oral | 250MG/PACKET | Marketed (Rx) | None | 0 | None |
| for suspension, oral | 500MG/PACKET | Marketed (Rx) | None | 0 | None |
NDA 206709, 207223, held by BIOCODEX SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Diacomit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-403 | Orphan drug exclusivity | July 14, 2029 | 206709 |
Diacomit NDC codes
Questions
Is there a generic for Diacomit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Diacomit (stiripentol). The Orange Book shows its last listed exclusivity ends July 14, 2029.
What is the generic name for Diacomit?
The active ingredient in Diacomit is stiripentol, 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.