Orange Book product · Brand (NDA)
KORSUVA
DIFELIKEFALIN ACETATE
At a glance
Aug 23, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 23, 2021
4 yr 11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 23, 2026
in 2 mo
Patent 10017536 expires
Listed drug substance patent expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 10138270 expires
Listed method-of-use patent (U-3204) expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 10793596 expires
Listed drug substance patent expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 7713937 expires
Listed drug substance patent expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 7727963 expires
Listed drug substance patent expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 8217007 expires
Listed method-of-use patent (U-3204) expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 8236766 expires
Listed method-of-use patent (U-3204) expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 8486894 expires
Listed method-of-use patent (U-3204) expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 8536131 expires
Listed drug substance patent expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 9334305 expires
Listed method-of-use patent (U-3204) expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 9359399 expires
Listed method-of-use patent (U-3204) expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 7402564 expires
Listed drug substance patent expiration.
Nov 12, 2032
in 6 yr 6 mo
Pharmaceutical detail
Active ingredient
DIFELIKEFALIN ACETATE
Strength
EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 214916
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 (1)
- NCENew chemical entity exclusivity (5 years)
Aug 23, 2026
in 2 mo
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10017536 | Nov 12, 2027 | in 1 yr 5 mo | SubstanceU-3204 |
| 10138270 | Nov 12, 2027 | in 1 yr 5 mo | U-3204 |
| 10793596 | Nov 12, 2027 | in 1 yr 5 mo | SubstanceProductU-3204 |
| 7713937 | Nov 12, 2027 | in 1 yr 5 mo | SubstanceProductU-3204 |
| 7727963 | Nov 12, 2027 | in 1 yr 5 mo | SubstanceProductU-3204 |
| 8217007 | Nov 12, 2027 | in 1 yr 5 mo | U-3204 |
| 8236766 | Nov 12, 2027 | in 1 yr 5 mo | U-3204 |
| 8486894 | Nov 12, 2027 | in 1 yr 5 mo | U-3204 |
| 8536131 | Nov 12, 2027 | in 1 yr 5 mo | SubstanceProductU-3204 |
| 9334305 | Nov 12, 2027 | in 1 yr 5 mo | U-3204 |
| 9359399 | Nov 12, 2027 | in 1 yr 5 mo | U-3204 |
| 7402564 | Nov 12, 2032 | in 6 yr 6 mo | SubstanceProductU-3204 |
