Details for New Drug Application (NDA): 208462

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NDA 208462 describes NINLARO, which is a drug marketed by Takeda Pharms Usa 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:	Takeda Pharms Usa
Ingredient:	ixazomib citrate
Patents:	9

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208462

Generic Entry Date for 208462^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 Action	Proteasome 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	Takeda Pharmaceuticals America, Inc.	63020-230	63020-230-01	1 CAPSULE in 1 BLISTER PACK (63020-230-01)
NINLARO	ixazomib citrate	CAPSULE;ORAL	208462	NDA	Takeda Pharmaceuticals America, Inc.	63020-230	63020-230-02	1 BLISTER PACK in 1 CARTON (63020-230-02) / 3 CAPSULE in 1 BLISTER PACK (63020-230-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 2.3MG BASE
Approval Date:	Nov 20, 2015	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 20, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Patent:	⤷ Sign Up	Patent Expiration:	Aug 6, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Aug 6, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Expired US Patents for NDA 208462

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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