Orange Book product · Brand (NDA)
FETROJA
CEFIDEROCOL SULFATE TOSYLATE
At a glance
Nov 14, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 2019
6 yr 8 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 14, 2024
1 yr 7 mo ago
Today
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Nov 14, 2029
in 3 yr 5 mo
Patent 9238657 expires
Listed drug substance patent expiration.
Nov 14, 2033
in 7 yr 6 mo
Patent 9238657 expires
Listed drug substance patent expiration.
Nov 14, 2033
in 7 yr 6 mo
Patent 9238657 expires
Listed drug substance patent expiration.
Nov 14, 2033
in 7 yr 6 mo
Patent 10004750 expires
Listed drug substance patent expiration.
Sep 03, 2035
in 9 yr 4 mo
Patent 9949982 expires
Listed drug product patent expiration.
Sep 03, 2035
in 9 yr 4 mo
Pharmaceutical detail
Active ingredient
CEFIDEROCOL SULFATE TOSYLATE
Strength
EQ 1GM BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 209445
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Nov 14, 2024
1 yr 7 mo ago
- GAINQualified infectious disease product exclusivity (adds 5 years)
Nov 14, 2029
in 3 yr 5 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9238657 | Nov 14, 2033 | in 7 yr 6 mo | SubstanceProductU-282 |
| 9238657 | Nov 14, 2033 | in 7 yr 6 mo | SubstanceProductU-3470 |
| 9238657 | Nov 14, 2033 | in 7 yr 6 mo | SubstanceProductU-3471 |
| 10004750 | Sep 03, 2035 | in 9 yr 4 mo | SubstanceProduct |
| 9949982 | Sep 03, 2035 | in 9 yr 4 mo | Product |
