Orange Book product · Brand (NDA)
JOURNAVX
SUZETRIGINE
Brand (NDA)NDA 219209RX VERTEX PHARMS INC
At a glance
Jan 30, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 30, 2025
1 yr 5 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jan 30, 2030
in 3 yr 8 mo
Patent 11834441 expires
Listed drug substance patent expiration.
Dec 04, 2040
in 14 yr 8 mo
Pharmaceutical detail
Active ingredient
SUZETRIGINE
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219209
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)
- NCENew chemical entity exclusivity (5 years)
Jan 30, 2030
in 3 yr 8 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11834441 | Dec 04, 2040 | in 14 yr 8 mo | SubstanceProductU-4125 |
