Orange Book product · Brand (NDA)
KYPROLIS
CARFILZOMIB
At a glance
Jul 20, 2012
Approved
Brand (NDA)
Application
AP
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 20, 2012
14 yr 1 mo ago
Today
Patent 7417042 expires
Listed drug substance patent expiration.
Jul 20, 2026
in 1 mo
Patent 7417042*PED expires
Listed listed patent expiration.
Jan 20, 2027
in 7 mo
Patent 7737112 expires
Listed drug product patent expiration.
Dec 07, 2027
in 1 yr 6 mo
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
May 22, 2028
in 1 yr 11 mo
Patent 7737112*PED expires
Listed listed patent expiration.
Jun 07, 2028
in 2 yr
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Nov 22, 2028
in 2 yr 6 mo
Patent RE47954 expires
Listed method-of-use patent (U-3449) expiration.
Oct 21, 2029
in 3 yr 5 mo
Patent RE47954*PED expires
Listed listed patent expiration.
Apr 21, 2030
in 3 yr 11 mo
Patent 9493582 expires
Listed drug product patent expiration.
Feb 27, 2033
in 6 yr 10 mo
Patent 9493582*PED expires
Listed listed patent expiration.
Aug 27, 2033
in 7 yr 4 mo
Pharmaceutical detail
Active ingredient
CARFILZOMIB
Strength
60MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
NDA 202714
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)
- M-14New use / labeling-change exclusivity (3 years)
May 22, 2028
in 1 yr 11 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 22, 2028
in 2 yr 6 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7417042 | Jul 20, 2026 | in 1 mo | SubstanceProduct |
| 7417042*PED | Jan 20, 2027 | in 7 mo | |
| 7737112 | Dec 07, 2027 | in 1 yr 6 mo | Product |
| 7737112*PED | Jun 07, 2028 | in 2 yr | |
| RE47954 | Oct 21, 2029 | in 3 yr 5 mo | U-3449 |
| RE47954*PED | Apr 21, 2030 | in 3 yr 11 mo | |
| 9493582 | Feb 27, 2033 | in 6 yr 10 mo | Product |
| 9493582*PED | Aug 27, 2033 | in 7 yr 4 mo |
