Ixazomib citrate - Generic Drug Details

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

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

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
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No			Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015		RX	Yes	No				Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No			Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No				Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No

International Patents for ixazomib citrate

Country	Patent Number	Title	Estimated Expiration
Cyprus	2017016
South Korea	20170068599	보로네이트 에스테르 화합물 및 이의 제약학적 조성물 (BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITION THEREOF)
Taiwan	I498333
Hong Kong	1182924	蛋白酶體抑制劑 (PROTEASOME INHIBITORS)
Tunisia	2010000060	PROTEASOME INHIBITORS
Japan	2014144981	BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF

Supplementary Protection Certificates for ixazomib citrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2178888	PA2017010,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
2178888	C 2017 012	Romania		PRODUCT NAME: IXAZOMIB SI SARURI SI ESTERI AI ACESTUIA ACCEPTABILE FARMACEUTIC, CA CITRAT DE IXAZOMIB; NATIONAL AUTHORISATION NUMBER: EU/1/16/1094; DATE OF NATIONAL AUTHORISATION: 20161121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1094; DATE OF FIRST AUTHORISATION IN EEA: 20161121
2178888	1790016-8	Sweden		PRODUCT NAME: IXAZOMIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND ESTERS THEREOF, SUCH AS IXAZOMIB CITRATE; REG. NO/DATE: EU/1/16/1094 20161123
2178888	LUC00013	Luxembourg		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	CA 2017 00014	Denmark		PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
2178888	17/2017	Austria		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