Orange Book product · Brand (NDA)
APHEXDA
MOTIXAFORTIDE ACETATE
At a glance
Sep 08, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 08, 2023
2 yr 10 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 08, 2028
in 2 yr 3 mo
Exclusivity ends · ODE-442
Orphan-drug exclusivity (7 years)
Sep 08, 2030
in 4 yr 3 mo
Patent 12257285 expires
Listed drug product patent expiration.
Dec 29, 2041
in 15 yr 9 mo
Patent 12268725 expires
Listed drug product patent expiration.
Dec 29, 2041
in 15 yr 9 mo
Pharmaceutical detail
Active ingredient
MOTIXAFORTIDE ACETATE
Strength
EQ 62MG BASE/VIAL
Dosage form
POWDER
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 217159
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)
Sep 08, 2028
in 2 yr 3 mo
- ODE-442Orphan-drug exclusivity (7 years)
Sep 08, 2030
in 4 yr 3 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12257285 | Dec 29, 2041 | in 15 yr 9 mo | Product |
| 12268725 | Dec 29, 2041 | in 15 yr 9 mo | Product |
