FDA Orange Book
Is there a generic for Imkeldi?
Imkeldi contains imatinib. 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 Imkeldi (imatinib). The Orange Book shows its last listed patent expires April 27, 2040.
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Imkeldi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | EQ 80MG BASE/ML | Marketed (Rx) | None | 0 | None |
NDA 219097, held by SHORLA ONCOLOGY. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Imkeldi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11957681 | April 27, 2040 | Drug product | None | 219097 |
Imkeldi NDC codes
Questions
Is there a generic for Imkeldi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Imkeldi (imatinib). The Orange Book shows its last listed patent expires April 27, 2040.
What is the generic name for Imkeldi?
The active ingredient in Imkeldi is imatinib, per the FDA Orange Book.
When does the Imkeldi patent expire?
The last patent listed for Imkeldi in the Orange Book expires April 27, 2040. 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.