Orange Book product · Brand (NDA)
TRUQAP
CAPIVASERTIB
At a glance
Nov 16, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 16, 2023
2 yr 8 mo ago
Today
Patent 10059714 expires
Listed drug substance patent expiration.
Oct 10, 2028
in 2 yr 4 mo
Patent 10654855 expires
Listed method-of-use patent (U-3762) expiration.
Oct 10, 2028
in 2 yr 4 mo
Patent 11760760 expires
Listed method-of-use patent (U-3762) expiration.
Oct 10, 2028
in 2 yr 4 mo
Patent 12252495 expires
Listed method-of-use patent (U-3762) expiration.
Oct 10, 2028
in 2 yr 4 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 16, 2028
in 2 yr 5 mo
Patent 8101623 expires
Listed drug substance patent expiration.
Mar 10, 2030
in 3 yr 9 mo
Patent 10039766 expires
Listed method-of-use patent (U-3762) expiration.
Apr 16, 2033
in 6 yr 11 mo
Patent 9487525 expires
Listed drug substance patent expiration.
Apr 16, 2033
in 6 yr 11 mo
Pharmaceutical detail
Active ingredient
CAPIVASERTIB
Strength
160MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 218197
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)
Nov 16, 2028
in 2 yr 5 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10059714 | Oct 10, 2028 | in 2 yr 4 mo | SubstanceProduct |
| 10654855 | Oct 10, 2028 | in 2 yr 4 mo | U-3762 |
| 11760760 | Oct 10, 2028 | in 2 yr 4 mo | U-3762 |
| 12252495 | Oct 10, 2028 | in 2 yr 4 mo | U-3762 |
| 8101623 | Mar 10, 2030 | in 3 yr 9 mo | SubstanceProductU-3762 |
| 10039766 | Apr 16, 2033 | in 6 yr 11 mo | U-3762 |
| 9487525 | Apr 16, 2033 | in 6 yr 11 mo | SubstanceProduct |
