Orange Book product · Brand (NDA)
EXONDYS 51
ETEPLIRSEN
At a glance
Sep 19, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 19, 2016
9 yr 11 mo ago
Today
Patent RE48468 expires
Listed method-of-use patent (U-2097) expiration.
Oct 27, 2028
in 2 yr 5 mo
Patent RE47769 expires
Listed drug product patent expiration.
Feb 02, 2029
in 2 yr 8 mo
Patent 10337003 expires
Listed method-of-use patent (U-1918) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 10364431 expires
Listed method-of-use patent (U-1919) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 10364431 expires
Listed method-of-use patent (U-1918) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9506058 expires
Listed method-of-use patent (U-1918) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9506058 expires
Listed method-of-use patent (U-1919) expiration.
Mar 14, 2034
in 7 yr 10 mo
Pharmaceutical detail
Active ingredient
ETEPLIRSEN
Strength
100MG/2ML (50MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 206488
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.
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE48468 | Oct 27, 2028 | in 2 yr 5 mo | U-2097 |
| RE47769 | Feb 02, 2029 | in 2 yr 8 mo | Product |
| 10337003 | Mar 14, 2034 | in 7 yr 10 mo | U-1918 |
| 10364431 | Mar 14, 2034 | in 7 yr 10 mo | U-1919 |
| 10364431 | Mar 14, 2034 | in 7 yr 10 mo | U-1918 |
| 9506058 | Mar 14, 2034 | in 7 yr 10 mo | U-1918 |
| 9506058 | Mar 14, 2034 | in 7 yr 10 mo | U-1919 |
