nedosiran sodium · Novo · NDA 215842
Rivfloza
Earliest generic entry, as listed · earliest of 3 marketed strengths
12 Oct 2038
Blocked by patent: US 11286488, US 11661604.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11286488 | substance, product, use U-3709 | 12 Oct 2038 |
| US 11661604 | substance, product, use U-3709 | 12 Oct 2038 |
| US 11053502 | substance, product | 29 Oct 2035 |
| US 10351854 | substance, product | 9 Oct 2035 |
| US 10738311 | substance, product, use U-3709 | 9 Oct 2035 |
| US 11359203 | substance, product, use U-3709 | 9 Oct 2035 |
Exclusivities · 4 unexpired
| ODE-531 | orphan drug (7 years) | 27 Mar 2032 |
| ODE-443 | orphan drug (7 years) | 29 Sep 2030 |
| NCE | new chemical entity (5 years) | 29 Sep 2028 |
| NPP | new patient population | 27 Mar 2028 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215842 · 001 · RLD | solution, injection | EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) | 12 Oct 2038 |
| 215842 · 002 · RLD | solution, injection | EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML) | 12 Oct 2038 |
| 215842 · 003 · RLD | solution, injection | EQ 160MG BASE/ML (EQ 160MG BASE/ML) | 12 Oct 2038 |