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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 202714


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NDA 202714 describes KYPROLIS, which is a drug marketed by Onyx Pharms Amgen and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and three Paragraph IV challenges. Additional details are available on the KYPROLIS profile page.

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.
Summary for 202714
Tradename:KYPROLIS
Applicant:Onyx Pharms Amgen
Ingredient:carfilzomib
Patents:4
Pharmacology for NDA: 202714
Mechanism of ActionProteasome Inhibitors
Suppliers and Packaging for NDA: 202714
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714 NDA Onyx Pharmaceuticals, Inc. 76075-101 76075-101-01 1 VIAL, SINGLE-USE in 1 CARTON (76075-101-01) / 30 mL in 1 VIAL, SINGLE-USE
KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714 NDA Onyx Pharmaceuticals, Inc. 76075-101 76075-101-21 1 VIAL, SINGLE-USE in 1 CARTON (76075-101-21) / 30 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength60MG/VIAL
Approval Date:Jul 20, 2012TE:APRLD:Yes
Regulatory Exclusivity Expiration:May 22, 2028
Regulatory Exclusivity Use:ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Regulatory Exclusivity Expiration:Nov 22, 2028
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:7,417,042*PEDPatent Expiration:Jan 20, 2027Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 202714

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 7,232,818 ⤷  Start Trial
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 8,207,127 ⤷  Start Trial
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-003 Jun 7, 2018 7,232,818 ⤷  Start Trial
Onyx Pharms Amgen KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 7,232,818 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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