Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

UBS
Farmers Insurance
QuintilesIMS
Healthtrust
Queensland Health
US Department of Justice
Cerilliant
Daiichi Sankyo
Dow

Generated: August 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208462

« Back to Dashboard

NDA 208462 describes NINLARO, which is a drug marketed by Millennium Pharms and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the NINLARO profile page.

The generic ingredient in NINLARO is ixazomib citrate. One supplier is listed for this compound. Additional details are available on the ixazomib citrate profile page.
Summary for 208462
Tradename:NINLARO
Applicant:Millennium Pharms
Ingredient:ixazomib citrate
Patents:9
Generic Entry Opportunity Date for 208462
Generic Entry Date for 208462*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*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: 208462
Mechanism of ActionProteasome Inhibitors
Suppliers and Packaging for NDA: 208462
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NINLARO ixazomib citrate CAPSULE;ORAL 208462 NDA Millennium Pharmaceuticals, Inc. 63020-078 N 63020-078-02
NINLARO ixazomib citrate CAPSULE;ORAL 208462 NDA Millennium Pharmaceuticals, Inc. 63020-079 N 63020-079-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2.3MG BASE
Approval Date:Nov 20, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 20, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 20, 2022
Regulatory Exclusivity Use:USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OFPATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Patent:➤ Sign UpPatent Expiration:Aug 6, 2027Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD FOR TREATING CANCER, INCLUDING MULTIPLE MYELOMA

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Teva
McKinsey
Harvard Business School
McKesson
Johnson and Johnson
Fish and Richardson
Julphar
Chinese Patent Office
Citi

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.