golodirsen · Sarepta Theraps Inc · NDA 211970
Vyondys 53
Earliest generic entry, as listed
28 Jun 2028
Blocked by patent: US RE47691.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US RE47691 | product | 28 Jun 2028 |
Exclusivities · 1 unexpired
| ODE-280 | orphan drug (7 years) | 12 Dec 2026 |
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
- 24 Oct 2026Exclusivity expires within 90 days ODE-280 · 211970-00112 Dec 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211970 · 001 · RLD | solution, intravenous | 100MG/2ML (50MG/ML) | 28 Jun 2028 |