Orange Book product · Brand (NDA)
TEMBEXA
BRINCIDOFOVIR
Brand (NDA)NDA 214460RX EMERGENT BIODEFENSE
At a glance
Jun 04, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 04, 2021
5 yr 1 mo ago
Today
Exclusivity ends · ODE-354
Orphan-drug exclusivity (7 years)
Jun 04, 2028
in 2 yr
Patent 9303051 expires
Listed drug substance patent expiration.
Jul 30, 2034
in 8 yr 3 mo
Pharmaceutical detail
Active ingredient
BRINCIDOFOVIR
Strength
10MG/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 214460
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-354Orphan-drug exclusivity (7 years)
Jun 04, 2028
in 2 yr
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9303051 | Jul 30, 2034 | in 8 yr 3 mo | SubstanceProductU-3165 |
