cefiderocol sulfate tosylate · Shionogi · NDA 209445
Fetroja
Earliest generic entry, as listed
3 Sep 2035
Blocked by patent: US 10004750, US 9949982.
Listed patents · 3 unexpired
5 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10004750 | drug substance, drug product · sets the listed date | 3 Sep 2035 |
| US 9949982 | drug product · sets the listed date | 3 Sep 2035 |
| US 9238657 | drug substance, drug product, use U-282, U-3470, U-3471 | 14 Nov 2033 |
| US 9238657 listing row | drug substance, drug product, use U-282 | 14 Nov 2033 |
| US 9238657 listing row | drug substance, drug product, use U-3470 | 14 Nov 2033 |
| US 9238657 listing row | drug substance, drug product, use U-3471 | 14 Nov 2033 |
Exclusivities · 1 unexpired
| GAIN | qualified infectious disease product | 14 Nov 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 |
|---|---|---|---|
| 209445 · 001 · RLD | powder, intravenous | EQ 1GM BASE/VIAL | 3 Sep 2035 |
Expired or delisted (1)
- NCE · 14 Nov 2024