Orange Book product · Brand (NDA)
TRYVIO
APROCITENTAN
At a glance
Mar 19, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 19, 2024
2 yr 3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 22, 2029
in 2 yr 10 mo
Patent 8324232 expires
Listed drug substance patent expiration.
Sep 21, 2029
in 3 yr 4 mo
Patent 11174247 expires
Listed method-of-use patent (U-3879) expiration.
Nov 06, 2037
in 11 yr 7 mo
Patent 10919881 expires
Listed drug substance patent expiration.
Feb 26, 2038
in 11 yr 10 mo
Patent 12297189 expires
Listed drug product patent expiration.
Feb 26, 2038
in 11 yr 10 mo
Patent 11787782 expires
Listed method-of-use patent (U-3877) expiration.
Mar 02, 2038
in 11 yr 10 mo
Patent 11680058 expires
Listed method-of-use patent (U-3878) expiration.
Jul 26, 2038
in 12 yr 3 mo
Pharmaceutical detail
Active ingredient
APROCITENTAN
Strength
12.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 217686
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)
Mar 22, 2029
in 2 yr 10 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8324232 | Sep 21, 2029 | in 3 yr 4 mo | SubstanceProductU-3878 |
| 11174247 | Nov 06, 2037 | in 11 yr 7 mo | U-3879 |
| 10919881 | Feb 26, 2038 | in 11 yr 10 mo | SubstanceProduct |
| 12297189 | Feb 26, 2038 | in 11 yr 10 mo | Product |
| 11787782 | Mar 02, 2038 | in 11 yr 10 mo | U-3877 |
| 11680058 | Jul 26, 2038 | in 12 yr 3 mo | U-3878 |
