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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

Tradename:1
Applicant:1
Ingredient:1
Patents:9

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?
Patented Use:METHOD FOR TREATING CANCER, INCLUDING MULTIPLE MYELOMA


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