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Ixazomib citrate - Generic Drug Details

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What are the generic drug sources for ixazomib citrate and what is the scope of ixazomib citrate freedom to operate?

Ixazomib citrate is the generic ingredient in one branded drug marketed by Millennium Pharms and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ixazomib citrate has two hundred and four patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for ixazomib citrate

International Patents:	204
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	16
Clinical Trials:	597
Patent Applications:	4
DailyMed Link:	ixazomib citrate at DailyMed

Pharmacology for ixazomib citrate

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Synonyms for ixazomib citrate

1,3,2-Dioxaborolane-4,4-diacetic acid, 2-((1R)-1-((2-((2,5-dichlorobenzoyl)amino)acetyl)amino)-3-methylbutyl)-5-oxo-

1239908-20-3

2-[(1R)-1-[[2-[(2,5-Dichlorobenzoyl)amino]acetyl]amino]-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diacetic acid

2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoy)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid

2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid

2,2'-{2-[(1R)-1-{[N-(2,5-dichlorobenzoyl)glycyl]amino}-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid

46CWK97Z3K

AKOS030632768

CHEBI:90939

CHEMBL3545432

CS-1720

D10131

FT-0699809

HY-10452

Ixazomib citrate (Ester)

Ixazomib citrate (JAN/USAN)

Ixazomib citrate [USAN]

KS-00000TRH

MBOMYENWWXQSNW-AWEZNQCLSA-N

MolPort-044-560-850

Ninlaro (TN)

SCHEMBL4427479

UNII-46CWK97Z3K

ZINC200299610

US Patents and Regulatory Information for ixazomib citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Millennium Pharms	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015		RX	Yes	No
Millennium Pharms	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015		RX	Yes	Yes			Y	Y
Millennium Pharms	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No			Y	Y
Millennium Pharms	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No

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Non-Orange Book US Patents for ixazomib citrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
2,014,018,301
8,772,536	Proteasome inhibitors
9,175,018	Boronate ester compounds and pharmaceutical compositions thereof
2,015,307,523

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International Patents for ixazomib citrate

Country	Document Number	Estimated Expiration
Spain	2330008
Argentina	095566
Brazil	PI0413582
Netherlands	300871

Supplementary Protection Certificates for ixazomib citrate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017010,C2178888	Lithuania		PRODUCT NAME: IKSAZOMIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA IR ESTERIS, TOKS KAIP IKSAZOMIBO CITRATAS; REGISTRATION NO/DATE: EU/1/16/1094 20161121
0871	Netherlands		PRODUCT NAME: IXAZOMIB EN FARMACEUTISCH AANVAARDBARE ZOUTEN EN ESTERS DAARVAN, ZOALS IXAZOMIBCITRAAT; REGISTRATION NO/DATE: EU/1/16/1094 20161123
2017 00014	Denmark		PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
2017000025	Germany		PRODUCT NAME: LXAZOMIB UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE UND ESTER WIE LXAZOMIBCITRAT; REGISTRATION NO/DATE: EU/1/16/1094 20161121