Orange Book product · Brand (NDA)
ARTESUNATE
ARTESUNATE
At a glance
May 26, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 26, 2020
6 yr 2 mo ago
Today
Exclusivity ends · ODE-290
Orphan-drug exclusivity (7 years)
May 26, 2027
in 11 mo
Patent 12121506 expires
Listed drug product patent expiration.
Feb 16, 2044
in 17 yr 11 mo
Patent 12390442 expires
Listed method-of-use patent (U-4433) expiration.
Feb 16, 2044
in 17 yr 11 mo
Pharmaceutical detail
Active ingredient
ARTESUNATE
Strength
110MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 213036
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 (1)
- ODE-290Orphan-drug exclusivity (7 years)
May 26, 2027
in 11 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12121506 | Feb 16, 2044 | in 17 yr 11 mo | Product |
| 12390442 | Feb 16, 2044 | in 17 yr 11 mo | U-4433 |
