Orange Book product · Brand (NDA)
SIVEXTRO
TEDIZOLID PHOSPHATE
At a glance
Jun 20, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 20, 2014
12 yr 2 mo ago
Today
Patent 8420676 expires
Listed drug substance patent expiration.
Feb 23, 2028
in 1 yr 8 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Apr 04, 2028
in 1 yr 10 mo
Patent 7816379 expires
Listed drug substance patent expiration.
Jun 20, 2028
in 2 yr
Patent 10065947 expires
Listed drug product patent expiration.
Feb 03, 2030
in 3 yr 8 mo
Patent 10442829 expires
Listed drug substance patent expiration.
Feb 03, 2030
in 3 yr 8 mo
Patent 9624250 expires
Listed drug substance patent expiration.
Feb 03, 2030
in 3 yr 8 mo
Patent 9988406 expires
Listed drug product patent expiration.
Feb 03, 2030
in 3 yr 8 mo
Patent 8426389 expires
Listed drug substance patent expiration.
Dec 31, 2030
in 4 yr 7 mo
Pharmaceutical detail
Active ingredient
TEDIZOLID PHOSPHATE
Strength
200MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 205436
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 (1)
- NPPNew patient population exclusivity (3 years)
Apr 04, 2028
in 1 yr 10 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8420676 | Feb 23, 2028 | in 1 yr 8 mo | SubstanceProductU-282 |
| 7816379 | Jun 20, 2028 | in 2 yr | SubstanceProductU-2507 |
| 10065947 | Feb 03, 2030 | in 3 yr 8 mo | Product |
| 10442829 | Feb 03, 2030 | in 3 yr 8 mo | Substance |
| 9624250 | Feb 03, 2030 | in 3 yr 8 mo | SubstanceProductU-2507 |
| 9988406 | Feb 03, 2030 | in 3 yr 8 mo | Product |
| 8426389 | Dec 31, 2030 | in 4 yr 7 mo | SubstanceProductU-282 |
