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Last Updated: January 30, 2023

Ixazomib citrate - Generic Drug Details


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

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-one patent family members in forty-five countries.

One supplier is listed for this compound.

Recent Clinical Trials for ixazomib citrate

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

SponsorPhase
AIDS Malignancy ConsortiumPhase 2
Sun Yat-sen UniversityPhase 2
TakedaPhase 2

See all ixazomib citrate clinical trials

Pharmacology for ixazomib citrate
Drug ClassProteasome 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

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-002 Nov 20, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-001 Nov 20, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-002 Nov 20, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-002 Nov 20, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Country Patent Number Title Estimated Expiration
Georgia, Republic of P201706703 BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF See Plans and Pricing
Canada 2727862 COMPOSES DE BORATES ESTERS ET COMPOSITIONS PHARMACEUTIQUES CONTENANT DES COMPOSES (BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF) See Plans and Pricing
Israel 234285 תהליך להכנת תרכובות של אסטר בורונאט וחומרי ביניים שלהם (Process for the preparation of boronate ester compounds and intermediates thereof) See Plans and Pricing
Costa Rica 11850 COMPUESTOS DE ÉSTER BORONATO Y COMPOSICIONES FARMACÉUTICAS DE LOS MISMOS See Plans and Pricing
European Patent Office 2318419 COMPOSÉS DE BORATES ESTERS ET COMPOSITIONS PHARMACEUTIQUES CONTENANT DES COMPOSÉS (BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF) See Plans and Pricing
China 103497232 Boronate ester compounds and pharmaceutical compositions thereof See Plans and Pricing
Mexico 2010013642 COMPUESTOS DE ESTER BORONATO Y COMPOSICIONES FARMACEUTICAS DE LOS MISMOS. (BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ixazomib citrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2178888 700 Finland See Plans and Pricing
2178888 CR 2017 00014 Denmark See Plans and Pricing PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE OG ESTERE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
2178888 122017000025 Germany See Plans and Pricing PRODUCT NAME: LXAZOMIB UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE UND ESTER WIE LXAZOMIBCITRAT; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888 132017000051594 Italy See Plans and Pricing PRODUCT NAME: IXAZOMIB E SUOI SALI ED ESTERI FARMACEUTICAMENTE ACCETTABILI, COME IXAZOMIB CITRATO(NINLARO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1094/001-003, 20161123
2178888 C 2017 012 Romania See Plans and Pricing 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 PA2017010 Lithuania See Plans and Pricing PRODUCT NAME: IKSAZOMIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR ESTERIAI, PAVYZDZIUI KAIP IKSAZOMIBO CITRATAS; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888 LUC00013 Luxembourg See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Merck
McKinsey
Moodys
Boehringer Ingelheim

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