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Last Updated: April 19, 2024

IXAZOMIB CITRATE - Generic Drug Details

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What are the generic 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-three patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for IXAZOMIB CITRATE

International Patents:	223
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

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

International Patents for IXAZOMIB CITRATE

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Country	Patent Number	Title	Estimated Expiration
Poland	2318419		⤷ Try a Trial
Japan	2014169316	BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF	⤷ Try a Trial
Israel	210056	תרכובות והרכבים רוקחיים המכילים אסטר בורונאט (Boronate ester compounds and pharmaceutical compositions thereof)	⤷ Try a Trial
Serbia	52435	INHIBITORI PROTEAZOMA (PROTEASOME INHIBITORS)	⤷ Try a Trial
Australia	2004268946	Proteasome inhibitors and methods of using the same	⤷ Try a Trial
>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	2017/016	Ireland	⤷ Try a Trial	PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888	C20170014 00227	Estonia	⤷ Try a Trial	PRODUCT NAME: IKSASOMIIB;REG NO/DATE: EU/1/16/1094 23.11.2016
2178888	17/2017	Austria	⤷ Try a Trial	PRODUCT NAME: IXAZOMIB UND PHARMAZEUTISCH ANNEHMBARE SALZE UND ESTER DAVON, WIE AUCH IXAZOMIB-CITRAT; REGISTRATION NO/DATE: EU/1/16/1094/ 001-003 (MITTEILUNG) 20161123
2178888	PA2017010	Lithuania	⤷ Try a Trial	PRODUCT NAME: IKSAZOMIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR ESTERIAI, PAVYZDZIUI KAIP IKSAZOMIBO CITRATAS; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888	SPC/GB17/030	United Kingdom	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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