Orange Book product · Brand (NDA)
KIMYRSA
ORITAVANCIN DIPHOSPHATE
At a glance
Mar 12, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 12, 2021
5 yr 4 mo ago
Today
Patent 12514899 expires
Listed method-of-use patent (U-4398) expiration.
Aug 29, 2029
in 3 yr 3 mo
Patent 8420592 expires
Listed method-of-use patent (U-3101) expiration.
Aug 29, 2029
in 3 yr 3 mo
Patent 9682061 expires
Listed method-of-use patent (U-3101) expiration.
Apr 26, 2030
in 3 yr 11 mo
Patent 9649352 expires
Listed drug substance patent expiration.
Jul 16, 2035
in 9 yr 2 mo
Pharmaceutical detail
Active ingredient
ORITAVANCIN DIPHOSPHATE
Strength
EQ 1.2GM BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 214155
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.
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 |
