Orange Book product · Brand (NDA)
VAFSEO
VADADUSTAT
At a glance
Mar 27, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 27, 2024
2 yr 3 mo ago
Today
Patent 8598210 expires
Listed drug substance patent expiration.
Jun 26, 2027
in 1 yr
Patent 8940773 expires
Listed method-of-use patent (U-3876) expiration.
Jun 26, 2027
in 1 yr
Patent RE47437 expires
Listed drug substance patent expiration.
Jun 26, 2027
in 1 yr
Patent 8343952 expires
Listed drug substance patent expiration.
Aug 14, 2027
in 1 yr 2 mo
Patent 7811595 expires
Listed drug substance patent expiration.
Mar 13, 2028
in 1 yr 9 mo
Patent 8323671 expires
Listed method-of-use patent (U-3876) expiration.
Apr 03, 2028
in 1 yr 10 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 27, 2029
in 2 yr 10 mo
Patent 12569474 expires
Listed method-of-use patent (U-3876) expiration.
Jun 04, 2034
in 8 yr 1 mo
Patent 11857543 expires
Listed method-of-use patent (U-3876) expiration.
Jun 09, 2034
in 8 yr 1 mo
Patent 10149842 expires
Listed drug substance patent expiration.
Nov 14, 2034
in 8 yr 6 mo
Patent 11065237 expires
Listed drug substance patent expiration.
Nov 14, 2034
in 8 yr 6 mo
Patent 9701636 expires
Listed drug substance patent expiration.
Nov 14, 2034
in 8 yr 6 mo
Patent 9987262 expires
Listed method-of-use patent (U-3876) expiration.
Nov 14, 2034
in 8 yr 6 mo
Patent 11324734 expires
Listed drug product patent expiration.
Mar 31, 2036
in 9 yr 11 mo
Patent 11844756 expires
Listed method-of-use patent (U-3876) expiration.
Mar 31, 2036
in 9 yr 11 mo
Pharmaceutical detail
Active ingredient
VADADUSTAT
Strength
150MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215192
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
- NCENew chemical entity exclusivity (5 years)
Mar 27, 2029
in 2 yr 10 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8598210 | Jun 26, 2027 | in 1 yr | SubstanceProduct |
| 8940773 | Jun 26, 2027 | in 1 yr | U-3876 |
| RE47437 | Jun 26, 2027 | in 1 yr | SubstanceProduct |
| 8343952 | Aug 14, 2027 | in 1 yr 2 mo | SubstanceProduct |
| 7811595 | Mar 13, 2028 | in 1 yr 9 mo | SubstanceProduct |
| 8323671 | Apr 03, 2028 | in 1 yr 10 mo | U-3876 |
| 12569474 | Jun 04, 2034 | in 8 yr 1 mo | U-3876 |
| 11857543 | Jun 09, 2034 | in 8 yr 1 mo | U-3876 |
| 10149842 | Nov 14, 2034 | in 8 yr 6 mo | SubstanceProduct |
| 11065237 | Nov 14, 2034 | in 8 yr 6 mo | SubstanceProductU-3876 |
| 9701636 | Nov 14, 2034 | in 8 yr 6 mo | SubstanceProduct |
| 9987262 | Nov 14, 2034 | in 8 yr 6 mo | U-3876 |
| 11324734 | Mar 31, 2036 | in 9 yr 11 mo | Product |
| 11844756 | Mar 31, 2036 | in 9 yr 11 mo | U-3876 |
