FDA Orange Book · active-ingredient family
Carfilzomib
Carfilzomib is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KYPROLIS · NDA 202714
1
Brand (NDA)
4
Generics (ANDA)
8
Listed patents
6
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KYPROLISRLD×3 | ONYX PHARMS AMGEN | NDA 202714 | — | Jun 07, 2018 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARFILZOMIB×2 | BRECKENRIDGE | ANDA 209330 | — | Jun 11, 2021 | |
| CARFILZOMIB | APOTEX | ANDA 211185 | — | Mar 20, 2020 | |
| CARFILZOMIB | APOTEX | ANDA 209425 | — | Mar 16, 2020 | |
| CARFILZOMIB | DR REDDYS | ANDA 209422 | AP | Sep 09, 2019 |
Marketing exclusivity (6)
- 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
- 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
- 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 |
Carfilzomib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
