Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
UBS
Queensland Health
Federal Trade Commission
Argus Health
Mallinckrodt
Cerilliant
Chubb
Cantor Fitzgerald
US Army

Generated: October 24, 2017

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 one Paragraph IV challenge. Additional details are available on the KYPROLIS profile page.

The generic ingredient in KYPROLIS is carfilzomib. There are nine 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 NDA: 202714

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:11

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

Summary 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 THEREPY
Regulatory Exclusivity Expiration:Jul 20, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


Complete Access Available with Subscription
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Baxter
Moodys
Deloitte
Fish and Richardson
UBS
Healthtrust
Express Scripts
Queensland Health

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot