FDA Orange Book
Is there a generic for Idhifa?
Idhifa contains enasidenib. 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 Idhifa (enasidenib). The Orange Book shows its last listed patent expires September 16, 2034.
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Idhifa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
NDA 209606, held by BRISTOL MYERS SQUIBB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Idhifa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10610125 | June 21, 2030 | Method of use | U-2087 | 209606 |
| 9512107 | January 7, 2033 | Drug substance, Drug product | U-2087 | 209606 |
| 10294215 | January 7, 2033 | Drug product | U-2087 | 209606 |
| 10093654 | August 1, 2034 | Drug substance, Drug product | U-2087 | 209606 |
| 9738625 | August 1, 2034 | Drug substance | None | 209606 |
| 9732062 | September 16, 2034 | Drug substance | None | 209606 |
Idhifa NDC codes
Questions
Is there a generic for Idhifa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Idhifa (enasidenib). The Orange Book shows its last listed patent expires September 16, 2034.
What is the generic name for Idhifa?
The active ingredient in Idhifa is enasidenib, per the FDA Orange Book.
When does the Idhifa patent expire?
The last patent listed for Idhifa in the Orange Book expires September 16, 2034. 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.