carfilzomib Injectable Solution
- Brand(s)
- Kyprolis
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Onyx Pharmaceuticals, Inc. (2015-07-31)
- Oldest Current Product
- 2012-07-20
- License(s)
- NDA
- RxNORM
- INJECTABLE SOLUTION\CARFILZOMIB
- FDAOB
- INTRAVENOUS\POWDER\CARFILZOMIB
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CARFILZOMIB
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CARFILZOMIB
product(s) by strength(s)
carfilzomib 2 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 760750101 | Kyprolis | NDA | Onyx Pharmaceuticals, Inc. | 2012-07-20 | CARFILZOMIB | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA202714 | ea66eb30-e665-4693-99a1-a9d3b4bbe2d6 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA202714 | KYPROLIS | ONYX PHARMACEUTICALS INC | 2012-07-20 | p8207297, SUBSTANCE p7417042, SUBSTANCE p8129346, TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY p8207125, SUBSTANCE p8207126, SUBSTANCE p8207127, TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY p7232818, SUBSTANCE p7737112, SUBSTANCE p7491704, TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY | ORPHAN DRUG EXCLUSIVITY [2019-07-20] EXPANDED INDICATION FOR USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE PRIOR LINES OF THEREPY [2018-07-24] NEW CHEMICAL ENTITY [2017-07-20] | NDA202714_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA202714_001 | RX | CARFILZOMIB (60MG/VIAL) | INTRAVENOUS | POWDER | True | 2012-07-20 | KYPROLIS |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7232818 (view patent) | 2025-04-14 | NDA202714 |
| 2 | p7417042 (view patent) | 2026-06-07 | NDA202714 |
| 3 | p7491704 (view patent) | 2025-04-14 | NDA202714 |
| 4 | p7737112 (view patent) | 2027-12-07 | NDA202714 |
| 5 | p8129346 (view patent) | 2026-12-25 | NDA202714 |
| 6 | p8207125 (view patent) | 2025-04-14 | NDA202714 |
| 7 | p8207126 (view patent) | 2025-04-14 | NDA202714 |
| 8 | p8207127 (view patent) | 2025-04-14 | NDA202714 |
| 9 | p8207297 (view patent) | 2025-04-14 | NDA202714 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ea66eb30-e665-4693-99a1-a9d3b4bbe2d6 (view SPL) | These highlights do not include all the information needed to use KYPROLIS safely and effectively. See full prescribing information for KYPROLIS. KYPROLIS (carfilzomib) for injection, for intravenous use Initial U.S. Approval: 2012 | prescription | Human Prescription | Onyx Pharmaceuticals, Inc. | ANALYSIS, MANUFACTURE, PACK | 2015-07-31 | 7 | 760750101 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII