Ixazomib citrate - Generic Drug Details

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What are the generic drug sources for ixazomib citrate and what is the scope of patent protection?

Ixazomib citrate is the generic ingredient in one branded drug marketed by Takeda Pharms Usa 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 twenty-four patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for ixazomib citrate

International Patents:	224
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	37
Patent Applications:	617
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ixazomib citrate
DailyMed Link:	ixazomib citrate at DailyMed

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

Generic Entry Date for ixazomib citrate^: ⤷ 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.

Recent Clinical Trials for ixazomib citrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AIDS Malignancy Consortium	Phase 2
Sun Yat-sen University	Phase 2
Takeda	Phase 2

See all ixazomib citrate clinical trials

Pharmacology for ixazomib citrate

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ixazomib citrate

L01XG	Proteasome inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IXAZOMIB CITRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NINLARO	Capsules	ixazomib citrate	2.3 mg, 3 mg and 4 mg	208462	1	2019-11-20

US Patents and Regulatory Information for ixazomib citrate

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Glossary

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

Expired US Patents for ixazomib citrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015	⤷ Sign Up	⤷ Sign Up
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	208462-003	Nov 20, 2015	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ixazomib citrate

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Country	Patent Number	Title	Estimated Expiration
Israel	173722	PROTEASOME INHIBITORS AND METHODS OF USING THE SAME	⤷ Sign Up
Japan	2010535759		⤷ Sign Up
China	103450241	Borate compound and medicine composition thereof	⤷ Sign Up
Hong Kong	1091839	PROTEASOME INHIBITORS AND METHODS OF USING THE SAME	⤷ Sign Up
European Patent Office	2733147	Composés de borates esters et compositions pharmaceutiques contenant des composés (Boronate ester compounds and pharmaceutical compositions thereof)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ixazomib citrate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2178888	CR 2017 00014	Denmark	⤷ Sign Up	PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE OG ESTERE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
2178888	C02178888/01	Switzerland	⤷ Sign Up	PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65959 03.02.2017
2178888	LUC00013	Luxembourg	⤷ Sign Up	PRODUCT NAME: IXAZOMIB ET SELS ET ESTERS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI, TEL QUE LE CITRATE D'IXAZOMIB; AUTHORISATION NUMBER AND DATE: EU/1/16/&1094 20161123
2178888	SPC/GB17/030	United Kingdom	⤷ Sign Up	PRODUCT NAME: IXAZOMIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND ESTERS THEREOF, SUCH AS IXAZOMIB CITRATE; REGISTERED: UK EU/1/16/1094/001(NI) 20161123; UK EU/1/16/1094/002(NI) 20161123; UK EU/1/16/1094/003(NI) 20161123; UK PLGB 15475/0059 20161123; UK PLGB 15475/0060 20161123; UK PLGB 15475/0061 20161123
2178888	PA2017010	Lithuania	⤷ Sign Up	PRODUCT NAME: IKSAZOMIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR ESTERIAI, PAVYZDZIUI KAIP IKSAZOMIBO CITRATAS; REGISTRATION NO/DATE: EU/1/16/1094 20161121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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