Orange Book product · Brand (NDA)
TEMBEXA
BRINCIDOFOVIR
At a glance
Jun 04, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
5
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
Patent 10112909 expires
Listed method-of-use patent (U-3165) expiration.
Oct 10, 2034
in 8 yr 5 mo
Patent 10487061 expires
Listed drug product patent expiration.
Oct 10, 2034
in 8 yr 5 mo
Patent 8962829 expires
Listed drug substance patent expiration.
Oct 10, 2034
in 8 yr 5 mo
Patent 9371344 expires
Listed drug product patent expiration.
Oct 10, 2034
in 8 yr 5 mo
Pharmaceutical detail
Active ingredient
BRINCIDOFOVIR
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 214461
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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9303051 | Jul 30, 2034 | in 8 yr 3 mo | SubstanceProductU-3165 |
| 10112909 | Oct 10, 2034 | in 8 yr 5 mo | U-3165 |
| 10487061 | Oct 10, 2034 | in 8 yr 5 mo | ProductU-3165 |
| 8962829 | Oct 10, 2034 | in 8 yr 5 mo | SubstanceProduct |
| 9371344 | Oct 10, 2034 | in 8 yr 5 mo | Product |
