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Federal Trade Commission
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Chinese Patent Office
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208462

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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


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 63020-078-02 3 BLISTER PACK in 1 CARTON (63020-078-02) > 1 CAPSULE in 1 BLISTER PACK (63020-078-01)
NINLARO ixazomib citrate CAPSULE;ORAL 208462 NDA Millennium Pharmaceuticals, Inc. 63020-079 63020-079-02 3 BLISTER PACK in 1 CARTON (63020-079-02) > 1 CAPSULE in 1 BLISTER PACK (63020-079-01)

Summary 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:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Aug 6, 2027Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Argus Health
Queensland Health
Johnson and Johnson
Fish and Richardson

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.

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