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Last Updated: November 4, 2024

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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-four 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

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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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Proteasome inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Boronate ester compounds and pharmaceutical compositions thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Proteasome inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
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 208462-003 Nov 20, 2015 RX Yes Yes ⤷  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 ⤷  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 208462-002 Nov 20, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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 NINLARO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 208462-001 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
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-002 Nov 20, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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
Patent: COMPUESTOS DE ACIDO BORONICO Y ESTER BORONICO INHIBIDORES DE LA PROTEASOMA, COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN Y USOS DE LOS MISMOS PARA EL TRATAMIENTO DEL CANCER.
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 07357338
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0721905
Patent: INIBIDORES DE PROTEASSOMA
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 95082
Patent: INHIBITEURS DE PROTEASOMES (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 08002159
Patent: Compuestos derivados de n-(((1r, 4r)-4-aminociclohexil)metil) sulfonaminas sustituidas con heterociclos, antagonistas del receptor npy y5; composicion farmaceutica que comprende a dichos compuestos, utiles para tratar anorexia y obesidad.
Estimated Expiration: ⤷  Sign Up

China

Patent: 1772507
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 2961387
Patent: Proteasome inhibitor
Estimated Expiration: ⤷  Sign Up

Patent: 5837608
Patent: 蛋白酶体抑制剂及其组合物和用途 (Proteasome inhibitor and composition and application thereof)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0120745
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 13386
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 78888
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 10010015
Patent: INHIBIDORES DE PROTEASOMA
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 8622
Patent: ИНГИБИТОРЫ ПРОТЕАСОМ (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 1070247
Patent: ИНГИБИТОРЫ ПРОТЕАСОМ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 78888
Patent: INHIBITEURS DE PROTÉASOMES (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 27347
Patent: Inhibiteurs de protéasome (Proteasome inhibitors)
Estimated Expiration: ⤷  Sign Up

Patent: 10987
Patent: PROCÉDÉ POUR LA SYNTHÈSE D'INHIBITEURS DE PROTÉASOMES (PROCESS FOR THE SYNTHESIS OF PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Sign Up

France

Patent: C1011
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0125599
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 43595
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Sign Up

Patent: 82924
Patent: 蛋白酶體抑制劑 (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 700018
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 3641
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷  Sign Up

Patent: 2290
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷  Sign Up

Patent: 2291
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷  Sign Up

Patent: 2292
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 61488
Estimated Expiration: ⤷  Sign Up

Patent: 10535759
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 178888
Estimated Expiration: ⤷  Sign Up

Patent: 2017010
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 0013
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 1991
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0871
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 2693
Patent: Boron-containing proteasome inhibitors
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 014500053
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 78888
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 78888
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 435
Patent: INHIBITORI PROTEAZOMA (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201508712Q
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 78888
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1000348
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1474831
Estimated Expiration: ⤷  Sign Up

Patent: 1831674
Estimated Expiration: ⤷  Sign Up

Patent: 100059811
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Sign Up

Patent: 140042932
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Sign Up

Patent: 140042933
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Sign Up

Patent: 150010802
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Sign Up

Patent: 160040735
Patent: 프로테아좀 억제제 (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 170004031
Patent: 프로테아좀 억제제 (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 90606
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 40641
Estimated Expiration: ⤷  Sign Up

Patent: 11972
Estimated Expiration: ⤷  Sign Up

Patent: 42594
Estimated Expiration: ⤷  Sign Up

Patent: 0914460
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 1425320
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 1425321
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 1700482
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 10000060
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 536
Patent: ІНГІБІТОРИ ПРОТЕАСОМ[ИНГИБИТОРЫ ПРОТЕАСОМ (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Sign Up

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
Israel 173722 PROTEASOME INHIBITORS AND METHODS OF USING THE SAME ⤷  Sign Up
Japan 2010535759 ⤷  Sign Up
China 103450241 Borate compound and medicine composition thereof ⤷  Sign Up
Hong Kong 1091839 PROTEASOME INHIBITORS AND METHODS OF USING THE SAME ⤷  Sign Up
European Patent Office 2733147 Composés de borates esters et compositions pharmaceutiques contenant des composés (Boronate ester compounds and pharmaceutical compositions thereof) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2009020448 ⤷  Sign Up
Serbia 52435 INHIBITORI PROTEAZOMA (PROTEASOME INHIBITORS) ⤷  Sign Up
>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 ⤷  Sign Up PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE OG ESTERE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
2178888 C02178888/01 Switzerland ⤷  Sign Up PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65959 03.02.2017
2178888 LUC00013 Luxembourg ⤷  Sign Up 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 SPC/GB17/030 United Kingdom ⤷  Sign Up PRODUCT NAME: IXAZOMIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND ESTERS THEREOF, SUCH AS IXAZOMIB CITRATE; REGISTERED: UK EU/1/16/1094/001(NI) 20161123; UK EU/1/16/1094/002(NI) 20161123; UK EU/1/16/1094/003(NI) 20161123; UK PLGB 15475/0059 20161123; UK PLGB 15475/0060 20161123; UK PLGB 15475/0061 20161123
2178888 PA2017010 Lithuania ⤷  Sign Up PRODUCT NAME: IKSAZOMIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR ESTERIAI, PAVYZDZIUI KAIP IKSAZOMIBO CITRATAS; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888 132017000051594 Italy ⤷  Sign Up 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 2017/016 Ireland ⤷  Sign Up 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.