Orange Book product · Brand (NDA)
XACDURO (COPACKAGED)
DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM
At a glance
May 23, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 23, 2023
3 yr 1 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 23, 2028
in 1 yr 11 mo
Patent 9309245 expires
Listed drug substance patent expiration.
Apr 02, 2033
in 6 yr 11 mo
Patent 9623014 expires
Listed method-of-use patent (U-2840) expiration.
Apr 02, 2033
in 6 yr 11 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
May 23, 2033
in 7 yr
Patent 10376499 expires
Listed drug product patent expiration.
Nov 17, 2035
in 9 yr 7 mo
Patent 9968593 expires
Listed drug product patent expiration.
Nov 17, 2035
in 9 yr 7 mo
Pharmaceutical detail
Active ingredient
DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM
Strength
EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 216974
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 (2)
- NCENew chemical entity exclusivity (5 years)
May 23, 2028
in 1 yr 11 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
May 23, 2033
in 7 yr
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9309245 | Apr 02, 2033 | in 6 yr 11 mo | Substance |
| 9623014 | Apr 02, 2033 | in 6 yr 11 mo | U-2840 |
| 10376499 | Nov 17, 2035 | in 9 yr 7 mo | ProductU-2840 |
| 9968593 | Nov 17, 2035 | in 9 yr 7 mo | ProductU-2840 |
