FDA Orange Book
Is there a generic for Lampit?
Lampit contains nifurtimox. 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 Lampit (nifurtimox). The Orange Book shows its last listed exclusivity ends August 6, 2027.
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Lampit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 120MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 30MG | Marketed (Rx) | None | 0 | None |
NDA 213464, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lampit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-319 | Orphan drug exclusivity | August 6, 2027 | 213464 |
Lampit NDC codes
Questions
Is there a generic for Lampit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lampit (nifurtimox). The Orange Book shows its last listed exclusivity ends August 6, 2027.
What is the generic name for Lampit?
The active ingredient in Lampit is nifurtimox, 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.