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	208462-002	Nov 20, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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	208462-001	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
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
Hong Kong	1091839	PROTEASOME INHIBITORS AND METHODS OF USING THE SAME	⤷ Sign Up
Taiwan	201002727	Boronate ester compounds and pharmaceutical compositions thereof	⤷ Sign Up
China	103450241	Borate compound and medicine composition thereof	⤷ Sign Up
China	101772507	Proteasome inhibitors	⤷ Sign Up
Israel	234285	תהליך להכנת תרכובות של אסטר בורונאט וחומרי ביניים שלהם (Process for the preparation of boronate ester compounds and intermediates thereof)	⤷ Sign Up
Australia	2004268946	Proteasome inhibitors and methods of using the same	⤷ 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	275 50004-2017	Slovakia	⤷ Sign Up	PRODUCT NAME: IXAZOMIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1094 20161123
2178888	1790016-8	Sweden	⤷ Sign Up	PRODUCT NAME: IXAZOMIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND ESTERS THEREOF, SUCH AS IXAZOMIB CITRATE; REG. NO/DATE: EU/1/16/1094 20161123
2178888	PA2017010,C2178888	Lithuania	⤷ Sign Up	PRODUCT NAME: IKSAZOMIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA IR ESTERIS, TOKS KAIP IKSAZOMIBO CITRATAS; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888	17C1011	France	⤷ Sign Up	PRODUCT NAME: IXAZOMIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET SES ESTERS TELS QUE LE CITRATE D'IXAZOMIB; REGISTRATION NO/DATE: EU/1/16/1094 20161123
2178888	300871	Netherlands	⤷ Sign Up	PRODUCT NAME: IXAZOMIB EN FARMACEUTISCH AANVAARDBARE ZOUTEN EN ESTERS DAARVAN, ZOALS IXAZOMIBCITRAAT; REGISTRATION NO/DATE: EU/1/16/1094 20161123
2178888	122017000025	Germany	⤷ Sign Up	PRODUCT NAME: LXAZOMIB UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE UND ESTER WIE LXAZOMIBCITRAT; REGISTRATION NO/DATE: EU/1/16/1094 20161121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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