FDA Orange Book
Is there a generic for Egaten?
Egaten contains triclabendazole. 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 Egaten (triclabendazole). The Orange Book shows its last listed exclusivity ends February 13, 2026.
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Egaten products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MG | Marketed (Rx) | None | 0 | None |
NDA 208711, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Egaten exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-228 | Orphan drug exclusivity | February 13, 2026 | 208711 |
Egaten NDC codes
Questions
Is there a generic for Egaten?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Egaten (triclabendazole). The Orange Book shows its last listed exclusivity ends February 13, 2026.
What is the generic name for Egaten?
The active ingredient in Egaten is triclabendazole, 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.