olezarsen sodium · Ionis Pharms Inc · NDA 218614
Tryngolza (Autoinjector)
Earliest generic entry, as listed · earliest of 2 marketed strengths
1 May 2034
Blocked by patent: US 12509684, US 9127276, US 9163239, US 9181549.
Listed patents · 6 unexpired
8 Orange Book listing rows for 6 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12509684 | use U-4050, U-4580 | 1 May 2034 |
| US 12509684 listing row | use U-4050 · sets the listed date | 1 May 2034 |
| US 12509684 listing row | use U-4580 · sets the listed date | 1 May 2034 |
| US 9127276 | drug substance · sets the listed date | 1 May 2034 |
| US 9163239 | drug substance · sets the listed date | 1 May 2034 |
| US 9181549 | drug substance · sets the listed date | 1 May 2034 |
| US 9593333 | use U-4050 | 14 Feb 2034 |
| US 9157082 | use U-4050, U-4580 | 27 Apr 2032 |
| US 9157082 listing row | use U-4050 | 27 Apr 2032 |
| US 9157082 listing row | use U-4580 | 27 Apr 2032 |
Exclusivities · 3 unexpired
| ODE-515 | orphan drug (7 years) | 19 Dec 2031 |
| I-992 | new indication (3 years) | 24 Jun 2029 |
| NS | new strength | 24 Jun 2029 |
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 |
|---|---|---|---|
| 218614 · 001 · RLD | solution, subcutaneous | EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) | 1 May 2034 |
| 218614 · 002 · RLD | solution, subcutaneous | EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML) | 1 May 2034 |