FDA Orange Book · active-ingredient family
Oritavancin diphosphate
Oritavancin diphosphate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:KIMYRSA · NDA 214155
2
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KIMYRSARLD | MELINTA THERAP | NDA 214155 | — | Mar 12, 2021 | |
| ORBACTIVRLD | MELINTA THERAP | NDA 206334 | — | Aug 06, 2014 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12514899 | Aug 29, 2029 | in 3 yr 3 mo | U-4398 |
| 8420592 | Aug 29, 2029 | in 3 yr 3 mo | U-3101 |
| 9682061 | Apr 26, 2030 | in 3 yr 11 mo | U-3101 |
| 9649352 | Jul 16, 2035 | in 9 yr 2 mo | SubstanceProduct |
Oritavancin diphosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
