Orange Book product · Brand (NDA)
DIACOMIT
STIRIPENTOL
At a glance
Aug 20, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 20, 2018
7 yr 11 mo ago
Today
Exclusivity ends · ODE-403
Orphan-drug exclusivity (7 years)
Jul 14, 2029
in 3 yr 1 mo
Pharmaceutical detail
Active ingredient
STIRIPENTOL
Strength
500MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 206709
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)
- ODE-403Orphan-drug exclusivity (7 years)
Jul 14, 2029
in 3 yr 1 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
