Orange Book product · Brand (NDA)
DUVYZAT
GIVINOSTAT HYDROCHLORIDE
At a glance
Mar 21, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 21, 2024
2 yr 3 mo ago
Today
Patent 7329689 expires
Listed drug substance patent expiration.
Jan 15, 2027
in 7 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 21, 2029
in 2 yr 10 mo
Exclusivity ends · ODE-473
Orphan-drug exclusivity (7 years)
Mar 21, 2031
in 4 yr 10 mo
Patent 9421184 expires
Listed method-of-use patent (U-3885) expiration.
Feb 03, 2032
in 5 yr 9 mo
Patent 9867799 expires
Listed method-of-use patent (U-3885) expiration.
Feb 03, 2032
in 5 yr 9 mo
Patent 10688047 expires
Listed drug product patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 12606519 expires
Listed drug substance patent expiration.
May 03, 2040
in 14 yr 1 mo
Pharmaceutical detail
Active ingredient
GIVINOSTAT HYDROCHLORIDE
Strength
EQ 8.86MG BASE/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 217865
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 (2)
- NCENew chemical entity exclusivity (5 years)
Mar 21, 2029
in 2 yr 10 mo
- ODE-473Orphan-drug exclusivity (7 years)
Mar 21, 2031
in 4 yr 10 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7329689 | Jan 15, 2027 | in 7 mo | SubstanceProduct |
| 9421184 | Feb 03, 2032 | in 5 yr 9 mo | U-3885 |
| 9867799 | Feb 03, 2032 | in 5 yr 9 mo | U-3885 |
| 10688047 | Oct 28, 2036 | in 10 yr 6 mo | ProductU-3885 |
| 12606519 | May 03, 2040 | in 14 yr 1 mo | SubstanceProduct |
