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Last Updated: February 28, 2024

NINLARO Drug Patent Profile


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Which patents cover Ninlaro, and what generic alternatives are available?

Ninlaro is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-three patent family members in forty-six countries.

The generic ingredient in NINLARO is ixazomib citrate. One supplier is listed for this compound. Additional details are available on the ixazomib citrate profile page.

DrugPatentWatch® Generic Entry Outlook for Ninlaro

Ninlaro was eligible for patent challenges on November 20, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 20, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for NINLARO
Drug Prices for NINLARO

See drug prices for NINLARO

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

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

SponsorPhase
Rajshekhar Chakraborty, MDPhase 1/Phase 2
Genentech, Inc.Phase 1/Phase 2
TakedaPhase 4

See all NINLARO clinical trials

Pharmacology for NINLARO
Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
Paragraph IV (Patent) Challenges for NINLARO
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 NINLARO

NINLARO is protected by nine US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NINLARO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NINLARO

Proteasome inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Proteasome inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Proteasome inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Proteasome inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Proteasome inhibitors and methods of using the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Boronate ester compounds and pharmaceutical compositions thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Proteasome inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Boronate ester compounds and pharmaceutical compositions thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Proteasome inhibitors and methods of using the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

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 208462-001 Nov 20, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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 208462-001 Nov 20, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-001 Nov 20, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
>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 NINLARO

When does loss-of-exclusivity occur for NINLARO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 7824
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 07357338
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0721905
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 95082
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 08002159
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1772507
Estimated Expiration: ⤷  Try a Trial

Patent: 2961387
Estimated Expiration: ⤷  Try a Trial

Patent: 5837608
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0120745
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 13386
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 78888
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 10010015
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 8622
Estimated Expiration: ⤷  Try a Trial

Patent: 1070247
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 78888
Estimated Expiration: ⤷  Try a Trial

Patent: 27347
Estimated Expiration: ⤷  Try a Trial

Patent: 10987
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1011
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0125599
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 43595
Estimated Expiration: ⤷  Try a Trial

Patent: 82924
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 700018
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3641
Estimated Expiration: ⤷  Try a Trial

Patent: 2290
Estimated Expiration: ⤷  Try a Trial

Patent: 2291
Estimated Expiration: ⤷  Try a Trial

Patent: 2292
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 61488
Estimated Expiration: ⤷  Try a Trial

Patent: 10535759
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 178888
Estimated Expiration: ⤷  Try a Trial

Patent: 2017010
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 0013
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 1991
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 0871
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 2693
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 014500053
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 78888
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 78888
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 435
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201508712Q
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 78888
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1000348
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1474831
Estimated Expiration: ⤷  Try a Trial

Patent: 1831674
Estimated Expiration: ⤷  Try a Trial

Patent: 100059811
Estimated Expiration: ⤷  Try a Trial

Patent: 140042932
Estimated Expiration: ⤷  Try a Trial

Patent: 140042933
Estimated Expiration: ⤷  Try a Trial

Patent: 150010802
Estimated Expiration: ⤷  Try a Trial

Patent: 160040735
Estimated Expiration: ⤷  Try a Trial

Patent: 170004031
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 90606
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 40641
Estimated Expiration: ⤷  Try a Trial

Patent: 11972
Estimated Expiration: ⤷  Try a Trial

Patent: 42594
Estimated Expiration: ⤷  Try a Trial

Patent: 0914460
Estimated Expiration: ⤷  Try a Trial

Patent: 1425320
Estimated Expiration: ⤷  Try a Trial

Patent: 1425321
Estimated Expiration: ⤷  Try a Trial

Patent: 1700482
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 10000060
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 536
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NINLARO around the world.

Country Patent Number Title Estimated Expiration
Mexico PA06001687 INHIBIDORES DE PROTEASOMA Y METODOS DE USO DE LOS MISMOS. (PROTEASOME INHIBITORS AND METHODS OF USING THE SAME.) ⤷  Try a Trial
Lithuania C2178888 ⤷  Try a Trial
South Africa 201000348 PROTEASOME INHIBITORS ⤷  Try a Trial
China 103435638 Boronate ester compounds and pharmaceutical compositions thereof ⤷  Try a Trial
Argentina 072162 COMPUESTOS DE ESTER BORONATO Y COMPOSICIONES FARMACEUTICAS DE LOS MISMOS ⤷  Try a Trial
Poland 2178888 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NINLARO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2178888 CR 2017 00014 Denmark ⤷  Try a Trial PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE OG ESTERE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
2178888 PA2017010,C2178888 Lithuania ⤷  Try a Trial 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 ⤷  Try a Trial 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 300871 Netherlands ⤷  Try a Trial PRODUCT NAME: IXAZOMIB EN FARMACEUTISCH AANVAARDBARE ZOUTEN EN ESTERS DAARVAN, ZOALS IXAZOMIBCITRAAT; REGISTRATION NO/DATE: EU/1/16/1094 20161123
2178888 275 50004-2017 Slovakia ⤷  Try a Trial PRODUCT NAME: IXAZOMIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1094 20161123
2178888 2017/016 Ireland ⤷  Try a Trial PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: EU/1/16/1094 20161121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.