Orange Book product · Brand (NDA)
CUVRIOR
TRIENTINE TETRAHYDROCHLORIDE
At a glance
Apr 28, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2022
4 yr 2 mo ago
Today
Exclusivity ends · ODE-401
Orphan-drug exclusivity (7 years)
Apr 28, 2029
in 2 yr 11 mo
Patent 10988436 expires
Listed drug substance patent expiration.
May 03, 2039
in 13 yr 1 mo
Patent 11072577 expires
Listed method-of-use patent (U-3370) expiration.
May 03, 2039
in 13 yr 1 mo
Patent 12358861 expires
Listed drug substance patent expiration.
May 03, 2039
in 13 yr 1 mo
Patent 12358862 expires
Listed drug substance patent expiration.
May 03, 2039
in 13 yr 1 mo
Pharmaceutical detail
Active ingredient
TRIENTINE TETRAHYDROCHLORIDE
Strength
300MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215760
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)
- ODE-401Orphan-drug exclusivity (7 years)
Apr 28, 2029
in 2 yr 11 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10988436 | May 03, 2039 | in 13 yr 1 mo | Substance |
| 11072577 | May 03, 2039 | in 13 yr 1 mo | U-3370 |
| 12358861 | May 03, 2039 | in 13 yr 1 mo | SubstanceProductU-4262 |
| 12358862 | May 03, 2039 | in 13 yr 1 mo | SubstanceProductU-4262 |
