Orange Book product · Brand (NDA)
XERAVA
ERAVACYCLINE DIHYDROCHLORIDE
At a glance
Jun 03, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 03, 2020
6 yr 2 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 27, 2023
2 yr 10 mo ago
Today
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Aug 27, 2028
in 2 yr 3 mo
Patent 8796245 expires
Listed method-of-use patent (U-2380) expiration.
Aug 07, 2029
in 3 yr 2 mo
Patent 8906887 expires
Listed drug product patent expiration.
Aug 27, 2032
in 6 yr 3 mo
Patent 10961190 expires
Listed drug substance patent expiration.
Oct 19, 2037
in 11 yr 6 mo
Patent 11578044 expires
Listed drug substance patent expiration.
Oct 19, 2037
in 11 yr 6 mo
Pharmaceutical detail
Active ingredient
ERAVACYCLINE DIHYDROCHLORIDE
Strength
EQ 100MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 211109
Product number
002
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 (2)
- NCENew chemical entity exclusivity (5 years)
Aug 27, 2023
2 yr 10 mo ago
- GAINQualified infectious disease product exclusivity (adds 5 years)
Aug 27, 2028
in 2 yr 3 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8796245 | Aug 07, 2029 | in 3 yr 2 mo | U-2380 |
| 8906887 | Aug 27, 2032 | in 6 yr 3 mo | Product |
| 10961190 | Oct 19, 2037 | in 11 yr 6 mo | Substance |
| 11578044 | Oct 19, 2037 | in 11 yr 6 mo | Substance |
