sodium thiosulfate · Fennec Pharms Inc · NDA 212937
Pedmark
Earliest generic entry, as listed
1 Jul 2039
Blocked by patent: US 11291728, US 11510984, US 11617793, US 11964018, US 11992530, US 11998604.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11291728 | product | 1 Jul 2039 |
| US 11510984 | product | 1 Jul 2039 |
| US 11617793 | product | 1 Jul 2039 |
| US 11964018 | use U-3898 | 1 Jul 2039 |
| US 11992530 | use U-3948 | 1 Jul 2039 |
| US 11998604 | use U-3952 | 1 Jul 2039 |
Exclusivities · 1 unexpired
| ODE-384 | orphan drug (7 years) | 20 Sep 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212937 · 001 · RLD | solution, intravenous | 12.5GM/100ML (125MG/ML) | 1 Jul 2039 |
Expired or delisted (1)
- US 10596190 · use U-3443 · 5 Jan 2038 · delisted