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Last Updated: November 21, 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-four patent family members in forty-six countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IXAZOMIB CITRATE
Generic Entry Date for IXAZOMIB CITRATE*:
Constraining patent/regulatory exclusivity:
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

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 ActionProteasome 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 ⤷  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
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 RX Yes Yes ⤷  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

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

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
South Korea 20140042933 PROTEASOME INHIBITORS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IXAZOMIB CITRATE

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
2178888 C 2017 012 Romania ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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