eteplirsen · Sarepta Theraps Inc · NDA 206488
Exondys 51
Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Mar 2034
Blocked by patent: US 10337003, US 10364431, US 9506058. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
7 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10337003 | use U-1918 · sets the listed date | 14 Mar 2034 |
| US 10364431 | use U-1918, U-1919 | 14 Mar 2034 |
| US 10364431 listing row | use U-1918 · sets the listed date | 14 Mar 2034 |
| US 10364431 listing row | use U-1919 · sets the listed date | 14 Mar 2034 |
| US 9506058 | use U-1918, U-1919 | 14 Mar 2034 |
| US 9506058 listing row | use U-1918 · sets the listed date | 14 Mar 2034 |
| US 9506058 listing row | use U-1919 · sets the listed date | 14 Mar 2034 |
| US RE47769 | drug product | 2 Feb 2029 |
| US RE48468 | use U-2097 | 27 Oct 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206488 · 001 · RLD | solution, intravenous | 100MG/2ML (50MG/ML) | 14 Mar 2034 |
| 206488 · 002 · RLD | solution, intravenous | 500MG/10ML (50MG/ML) | 14 Mar 2034 |