FDA Orange Book
Is there a generic for iwilfin?
iwilfin contains eflornithine. 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 iwilfin (eflornithine). The Orange Book shows its last listed patent expires February 12, 2036 and its last listed exclusivity ends December 13, 2030.
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iwilfin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 192MG BASE | Marketed (Rx) | None | 0 | None |
NDA 215500, held by USWM LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
iwilfin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12582625 | February 12, 2036 | Method of use | U-4444 | 215500 |
iwilfin exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | December 13, 2026 | 215500 |
| ODE-462 | Orphan drug exclusivity | December 13, 2030 | 215500 |
iwilfin NDC codes
Questions
Is there a generic for iwilfin?
No. The Orange Book lists no active FDA-approved generic (ANDA) for iwilfin (eflornithine). The Orange Book shows its last listed patent expires February 12, 2036 and its last listed exclusivity ends December 13, 2030.
What is the generic name for iwilfin?
The active ingredient in iwilfin is eflornithine, per the FDA Orange Book.
When does the iwilfin patent expire?
The last patent listed for iwilfin in the Orange Book expires February 12, 2036. 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.