Orange Book product · Brand (NDA)
VANRAFIA
ATRASENTAN HYDROCHLORIDE
At a glance
Apr 02, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 02, 2025
1 yr 3 mo ago
Today
Patent 8623819 expires
Listed method-of-use patent (U-3980) expiration.
Aug 22, 2028
in 2 yr 3 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 02, 2030
in 3 yr 10 mo
Patent 11874283 expires
Listed method-of-use patent (U-3980) expiration.
Feb 18, 2032
in 5 yr 9 mo
Patent 10016393 expires
Listed drug product patent expiration.
Jul 07, 2034
in 8 yr 2 mo
Patent 9364458 expires
Listed drug product patent expiration.
Jul 07, 2034
in 8 yr 2 mo
Patent 11491137 expires
Listed method-of-use patent (U-3980) expiration.
Dec 16, 2040
in 14 yr 8 mo
Patent 11998526 expires
Listed method-of-use patent (U-3980) expiration.
Dec 16, 2040
in 14 yr 8 mo
Patent 12121509 expires
Listed method-of-use patent (U-3980) expiration.
Dec 16, 2040
in 14 yr 8 mo
Patent 12370174 expires
Listed method-of-use patent (U-3980) expiration.
Dec 16, 2040
in 14 yr 8 mo
Patent 12521369 expires
Listed method-of-use patent (U-3980) expiration.
Feb 23, 2041
in 14 yr 11 mo
Patent 12582631 expires
Listed method-of-use patent (U-3980) expiration.
Mar 25, 2043
in 17 yr
Pharmaceutical detail
Active ingredient
ATRASENTAN HYDROCHLORIDE
Strength
EQ 0.75MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219208
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)
- NCENew chemical entity exclusivity (5 years)
Apr 02, 2030
in 3 yr 10 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8623819 | Aug 22, 2028 | in 2 yr 3 mo | U-3980 |
| 11874283 | Feb 18, 2032 | in 5 yr 9 mo | U-3980 |
| 10016393 | Jul 07, 2034 | in 8 yr 2 mo | Product |
| 9364458 | Jul 07, 2034 | in 8 yr 2 mo | ProductU-3980 |
| 11491137 | Dec 16, 2040 | in 14 yr 8 mo | U-3980 |
| 11998526 | Dec 16, 2040 | in 14 yr 8 mo | U-3980 |
| 12121509 | Dec 16, 2040 | in 14 yr 8 mo | U-3980 |
| 12370174 | Dec 16, 2040 | in 14 yr 8 mo | U-3980 |
| 12521369 | Feb 23, 2041 | in 14 yr 11 mo | U-3980 |
| 12582631 | Mar 25, 2043 | in 17 yr | U-3980 |
