Orange Book product · Brand (NDA)
VILTEPSO
VILTOLARSEN
At a glance
Aug 12, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 12, 2020
5 yr 11 mo ago
Today
Exclusivity ends · ODE-280
Orphan-drug exclusivity (7 years)
Aug 12, 2027
in 1 yr 2 mo
Patent 10870676 expires
Listed drug substance patent expiration.
Aug 31, 2031
in 5 yr 3 mo
Patent 9079934 expires
Listed drug substance patent expiration.
Apr 03, 2034
in 7 yr 11 mo
Pharmaceutical detail
Active ingredient
VILTOLARSEN
Strength
250MG/5ML (50MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 212154
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-280Orphan-drug exclusivity (7 years)
Aug 12, 2027
in 1 yr 2 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10870676 | Aug 31, 2031 | in 5 yr 3 mo | SubstanceProductU-3039 |
| 9079934 | Apr 03, 2034 | in 7 yr 11 mo | SubstanceProduct |
