Orange Book product · Brand (NDA)
DOJOLVI
TRIHEPTANOIN
At a glance
Jun 30, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 30, 2020
6 yr 1 mo ago
Today
Exclusivity ends · ODE-311
Orphan-drug exclusivity (7 years)
Jun 30, 2027
in 1 yr 1 mo
Patent 8697748 expires
Listed drug product patent expiration.
Apr 28, 2029
in 2 yr 11 mo
Patent 12551461 expires
Listed drug product patent expiration.
Nov 14, 2034
in 8 yr 6 mo
Pharmaceutical detail
Active ingredient
TRIHEPTANOIN
Strength
100% w/w
Dosage form
LIQUID
Route
ORAL
TE code
Not listed
Application
NDA 213687
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-311Orphan-drug exclusivity (7 years)
Jun 30, 2027
in 1 yr 1 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8697748 | Apr 28, 2029 | in 2 yr 11 mo | Product |
| 12551461 | Nov 14, 2034 | in 8 yr 6 mo | Product |
