FDA Orange Book
Is there a generic for Zenbexus?
Zenbexus contains iberdomide. 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 Zenbexus (iberdomide). The Orange Book shows its last listed patent expires September 30, 2039 and its last listed exclusivity ends August 13, 2031.
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Zenbexus products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 0.75MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 1MG BASE | Marketed (Rx) | None | 0 | None |
NDA 221075, held by BRISTOL MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zenbexus patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9828361 | February 10, 2031 | Drug substance, Drug product | None | 221075 |
| 8518972 | June 5, 2031 | Drug substance, Drug product | None | 221075 |
| 9629849 | August 8, 2033 | Method of use | U-4598 | 221075 |
| 9221788 | September 25, 2033 | Drug substance | None | 221075 |
| RE50917 | October 7, 2034 | Method of use | U-4598 | 221075 |
| RE49647 | October 7, 2034 | Drug product | None | 221075 |
| 11529339 | September 30, 2039 | Method of use | U-4598 | 221075 |
Zenbexus exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 13, 2031 | 221075 |
Zenbexus NDC codes
Questions
Is there a generic for Zenbexus?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zenbexus (iberdomide). The Orange Book shows its last listed patent expires September 30, 2039 and its last listed exclusivity ends August 13, 2031.
What is the generic name for Zenbexus?
The active ingredient in Zenbexus is iberdomide, per the FDA Orange Book.
When does the Zenbexus patent expire?
The last patent listed for Zenbexus in the Orange Book expires September 30, 2039. 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.