Orange Book product · Brand (NDA)
VYONDYS 53
GOLODIRSEN
Brand (NDA)NDA 211970RX SAREPTA THERAPS INC
At a glance
Dec 12, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 12, 2019
6 yr 7 mo ago
Today
Exclusivity ends · ODE-280
Orphan-drug exclusivity (7 years)
Dec 12, 2026
in 6 mo
Patent RE47691 expires
Listed drug product patent expiration.
Jun 28, 2028
in 2 yr 1 mo
Pharmaceutical detail
Active ingredient
GOLODIRSEN
Strength
100MG/2ML (50MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 211970
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)
Dec 12, 2026
in 6 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE47691 | Jun 28, 2028 | in 2 yr 1 mo | Product |
