Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Queensland Health
Cantor Fitzgerald
Daiichi Sankyo
Cerilliant
QuintilesIMS
Mallinckrodt
Boehringer Ingelheim
US Department of Justice

Generated: October 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202714

« Back to Dashboard

NDA 202714 describes KYPROLIS, which is a drug marketed by Onyx Therap and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and two 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 Therap
Ingredient:carfilzomib
Patents:11
Generic Entry Opportunity Date for 202714
Generic Entry Date for 202714*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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. 76075-102 76075-102-01 1 VIAL, SINGLE-DOSE in 1 CARTON (76075-102-01) > 15 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength60MG/VIAL
Approval Date:Jul 20, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 21, 2019
Regulatory Exclusivity Use:AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY
Regulatory Exclusivity Expiration:Jul 24, 2018
Regulatory Exclusivity Use: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 THERAPY
Regulatory Exclusivity Expiration:Jan 21, 2019
Regulatory Exclusivity Use:REVISED INDICATION FOR USE IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY.

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Covington
Dow
Federal Trade Commission
Mallinckrodt
Harvard Business School
Cerilliant
Cantor Fitzgerald
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.