Orange Book product · Brand (NDA)
JESDUVROQ
DAPRODUSTAT
At a glance
Feb 01, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 01, 2023
3 yr 5 mo ago
Today
Patent 11643397 expires
Listed drug substance patent expiration.
Jun 22, 2027
in 1 yr
Patent 8557834 expires
Listed method-of-use patent (U-1238) expiration.
Jun 22, 2027
in 1 yr
Patent 8815884 expires
Listed drug product patent expiration.
Jun 22, 2027
in 1 yr
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Feb 01, 2028
in 1 yr 8 mo
Patent 8324208 expires
Listed drug substance patent expiration.
Dec 11, 2028
in 2 yr 6 mo
Patent 11117871 expires
Listed drug substance patent expiration.
Mar 13, 2038
in 11 yr 11 mo
Patent 11649217 expires
Listed drug product patent expiration.
Mar 13, 2038
in 11 yr 11 mo
Pharmaceutical detail
Active ingredient
DAPRODUSTAT
Strength
1MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 216951
Product number
001
Marketing status
DISCN
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)
Feb 01, 2028
in 1 yr 8 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11643397 | Jun 22, 2027 | in 1 yr | SubstanceU-3535 |
| 8557834 | Jun 22, 2027 | in 1 yr | U-1238 |
| 8815884 | Jun 22, 2027 | in 1 yr | ProductU-1238 |
| 8324208 | Dec 11, 2028 | in 2 yr 6 mo | SubstanceProduct |
| 11117871 | Mar 13, 2038 | in 11 yr 11 mo | SubstanceProductU-3535 |
| 11649217 | Mar 13, 2038 | in 11 yr 11 mo | ProductU-3535 |
