Orange Book product · Brand (NDA)
RECARBRIO
CILASTATIN SODIUM; IMIPENEM; RELEBACTAM
At a glance
Jul 16, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 16, 2019
7 yr ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 16, 2024
1 yr 11 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Dec 09, 2028
in 2 yr 6 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Jul 16, 2029
in 3 yr 1 mo
Patent 8487093 expires
Listed drug substance patent expiration.
Mar 21, 2033
in 6 yr 10 mo
Patent 8487093 expires
Listed drug substance patent expiration.
Mar 21, 2033
in 6 yr 10 mo
Patent 8487093 expires
Listed drug substance patent expiration.
Mar 21, 2033
in 6 yr 10 mo
Pharmaceutical detail
Active ingredient
CILASTATIN SODIUM; IMIPENEM; RELEBACTAM
Strength
EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 212819
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 (3)
- NCENew chemical entity exclusivity (5 years)
Jul 16, 2024
1 yr 11 mo ago
- NPPNew patient population exclusivity (3 years)
Dec 09, 2028
in 2 yr 6 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
Jul 16, 2029
in 3 yr 1 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8487093 | Mar 21, 2033 | in 6 yr 10 mo | SubstanceProductU-2587 |
| 8487093 | Mar 21, 2033 | in 6 yr 10 mo | SubstanceProductU-2840 |
| 8487093 | Mar 21, 2033 | in 6 yr 10 mo | SubstanceProductU-2586 |
