FDA Orange Book
Is there a generic for Xolremdi?
Xolremdi contains mavorixafor. 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 Xolremdi (mavorixafor). The Orange Book shows its last listed patent expires December 11, 2038 and its last listed exclusivity ends April 26, 2031.
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Xolremdi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | None | 0 | None |
NDA 218709, held by X4 PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xolremdi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10953003 | December 14, 2036 | Drug product | None | 218709 |
| 11219621 | December 22, 2036 | Method of use | U-3932 | 218709 |
| 10610527 | December 22, 2036 | Method of use | U-3932 | 218709 |
| 11045461 | December 11, 2038 | Drug product | None | 218709 |
| 12115156 | December 11, 2038 | Drug product | None | 218709 |
| 10548889 | December 11, 2038 | Drug product | None | 218709 |
Xolremdi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | April 26, 2029 | 218709 |
| ODE-480 | Orphan drug exclusivity | April 26, 2031 | 218709 |
Xolremdi NDC codes
Questions
Is there a generic for Xolremdi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xolremdi (mavorixafor). The Orange Book shows its last listed patent expires December 11, 2038 and its last listed exclusivity ends April 26, 2031.
What is the generic name for Xolremdi?
The active ingredient in Xolremdi is mavorixafor, per the FDA Orange Book.
When does the Xolremdi patent expire?
The last patent listed for Xolremdi in the Orange Book expires December 11, 2038. 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.