FDA Orange Book · active-ingredient family
Eteplirsen
Eteplirsen is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:EXONDYS 51 · NDA 206488
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EXONDYS 51RLD×2 | SAREPTA THERAPS INC | NDA 206488 | — | Sep 19, 2016 |
Listed patents (5)
| 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 |
| 9506058 | Mar 14, 2034 | in 7 yr 10 mo | U-1918 |
| 10364431 | Mar 14, 2034 | in 7 yr 10 mo | U-1919 |
| 10337003 | Mar 14, 2034 | in 7 yr 10 mo | U-1918 |
Eteplirsen — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
