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)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1760750101KyprolisNDAOnyx Pharmaceuticals, Inc.2012-07-20CARFILZOMIBINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA202714ea66eb30-e665-4693-99a1-a9d3b4bbe2d6

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202714KYPROLISONYX PHARMACEUTICALS INC2012-07-20p8207297, 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)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202714_001RXCARFILZOMIB (60MG/VIAL)INTRAVENOUSPOWDERTrue2012-07-20KYPROLIS

patent(s)

#idexpiration dateapplication(s)
1p7232818 (view patent)2025-04-14NDA202714
2p7417042 (view patent)2026-06-07NDA202714
3p7491704 (view patent)2025-04-14NDA202714
4p7737112 (view patent)2027-12-07NDA202714
5p8129346 (view patent)2026-12-25NDA202714
6p8207125 (view patent)2025-04-14NDA202714
7p8207126 (view patent)2025-04-14NDA202714
8p8207127 (view patent)2025-04-14NDA202714
9p8207297 (view patent)2025-04-14NDA202714

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1ea66eb30-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: 2012prescriptionHuman PrescriptionOnyx Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE, PACK2015-07-317760750101

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII