FDA Orange Book · active-ingredient family
Tedizolid phosphate
Tedizolid phosphate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SIVEXTRO · NDA 205436
2
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
2
Exclusivity periods
Brand (NDA) products · powder, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SIVEXTRORLD | CUBIST PHARMS LLC | NDA 205436 | — | Jun 20, 2014 | |
| SIVEXTRORLD | CUBIST PHARMS LLC | NDA 205435 | — | Jun 20, 2014 |
Marketing exclusivity (2)
- NPPNew patient population exclusivity (3 years)
Apr 04, 2028
in 1 yr 10 mo
- 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 |
| 9624250 | Feb 03, 2030 | in 3 yr 8 mo | SubstanceProductU-2507 |
| 9988406 | Feb 03, 2030 | in 3 yr 8 mo | Product |
| 10442829 | Feb 03, 2030 | in 3 yr 8 mo | Substance |
| 10065947 | Feb 03, 2030 | in 3 yr 8 mo | Product |
| 8426389 | Dec 31, 2030 | in 4 yr 7 mo | SubstanceProductU-282 |
Tedizolid phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
