Orange Book product · Brand (NDA)
ENSACOVE
ENSARTINIB HYDROCHLORIDE
At a glance
Dec 18, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 2024
1 yr 6 mo ago
Today
Patent 8551995 expires
Listed drug substance patent expiration.
Feb 09, 2029
in 2 yr 8 mo
Patent 9296724 expires
Listed drug substance patent expiration.
Jun 18, 2029
in 3 yr 1 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 18, 2029
in 3 yr 7 mo
Patent 9126947 expires
Listed drug substance patent expiration.
Nov 29, 2031
in 5 yr 6 mo
Patent 10899744 expires
Listed drug substance patent expiration.
Jun 01, 2037
in 11 yr 1 mo
Pharmaceutical detail
Active ingredient
ENSARTINIB HYDROCHLORIDE
Strength
EQ 100MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 218171
Product number
002
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)
Dec 18, 2029
in 3 yr 7 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8551995 | Feb 09, 2029 | in 2 yr 8 mo | Substance |
| 9296724 | Jun 18, 2029 | in 3 yr 1 mo | SubstanceU-4099 |
| 9126947 | Nov 29, 2031 | in 5 yr 6 mo | Substance |
| 10899744 | Jun 01, 2037 | in 11 yr 1 mo | SubstanceU-4099 |
