inotersen sodium · Akcea Theraps · NDA 211172
Tegsedi
Earliest generic entry, as listed
29 Apr 2031
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8697860, US 9061044, US 9399774.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8697860 | product | 29 Apr 2031 |
| US 9061044 | substance | 29 Apr 2031 |
| US 9399774 | use U-2430 | 29 Apr 2031 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211172 · 001 · RLD · discontinued | solution, subcutaneous | EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) | 29 Apr 2031 |