Orange Book product · Brand (NDA)
XOLREMDI
MAVORIXAFOR
At a glance
Apr 26, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 26, 2024
2 yr 2 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 26, 2029
in 2 yr 11 mo
Exclusivity ends · ODE-480
Orphan-drug exclusivity (7 years)
Apr 26, 2031
in 4 yr 11 mo
Patent 10953003 expires
Listed drug product patent expiration.
Dec 14, 2036
in 10 yr 8 mo
Patent 10610527 expires
Listed method-of-use patent (U-3932) expiration.
Dec 22, 2036
in 10 yr 8 mo
Patent 11219621 expires
Listed method-of-use patent (U-3932) expiration.
Dec 22, 2036
in 10 yr 8 mo
Patent 10548889 expires
Listed drug product patent expiration.
Dec 11, 2038
in 12 yr 8 mo
Patent 11045461 expires
Listed drug product patent expiration.
Dec 11, 2038
in 12 yr 8 mo
Patent 12115156 expires
Listed drug product patent expiration.
Dec 11, 2038
in 12 yr 8 mo
Pharmaceutical detail
Active ingredient
MAVORIXAFOR
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 218709
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Apr 26, 2029
in 2 yr 11 mo
- ODE-480Orphan-drug exclusivity (7 years)
Apr 26, 2031
in 4 yr 11 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10953003 | Dec 14, 2036 | in 10 yr 8 mo | Product |
| 10610527 | Dec 22, 2036 | in 10 yr 8 mo | U-3932 |
| 11219621 | Dec 22, 2036 | in 10 yr 8 mo | U-3932 |
| 10548889 | Dec 11, 2038 | in 12 yr 8 mo | Product |
| 11045461 | Dec 11, 2038 | in 12 yr 8 mo | Product |
| 12115156 | Dec 11, 2038 | in 12 yr 8 mo | Product |
