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
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 205435
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 |
