donidalorsen sodium · Ionis Pharms Inc · NDA 219407
Dawnzera (Autoinjector)
Earliest generic entry, as listed
1 May 2035
Blocked by patent: US 10294477.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10294477 | substance, product, use U-3010 | 1 May 2035 |
| US 9670492 | substance | 28 Aug 2034 |
| US 9127276 | substance | 1 May 2034 |
| US 9181549 | substance | 1 May 2034 |
| US 9315811 | use U-3010 | 21 Oct 2032 |
Exclusivities · 1 unexpired
| ODE-550 | orphan drug (7 years) | 21 Aug 2032 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 219407 · 001 · RLD | solution, subcutaneous | EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) | 1 May 2035 |