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Last Updated: September 25, 2022

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-one patent family members in forty-five countries.

The generic ingredient in NINLARO is ixazomib citrate. Two suppliers are 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 Generic Entry Opportunity 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 Action Proteasome 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 and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NINLARO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Proteasome inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Boronate ester compounds and pharmaceutical compositions thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Proteasome inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

FDA Regulatory Exclusivity protecting NINLARO

USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OFPATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Exclusivity Expiration: 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
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 208462-003 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 208462-001 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 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 208462-001 Nov 20, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y 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 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: See Plans and Pricing

Australia

Patent: 07357338
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0721905
Estimated Expiration: See Plans and Pricing

Canada

Patent: 95082
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08002159
Estimated Expiration: See Plans and Pricing

China

Patent: 1772507
Estimated Expiration: See Plans and Pricing

Patent: 2961387
Estimated Expiration: See Plans and Pricing

Patent: 5837608
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120745
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 13386
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 78888
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010015
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8622
Estimated Expiration: See Plans and Pricing

Patent: 1070247
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 78888
Estimated Expiration: See Plans and Pricing

Patent: 27347
Estimated Expiration: See Plans and Pricing

Patent: 10987
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0125599
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 43595
Estimated Expiration: See Plans and Pricing

Patent: 82924
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 700018
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3641
Estimated Expiration: See Plans and Pricing

Patent: 2290
Estimated Expiration: See Plans and Pricing

Patent: 2291
Estimated Expiration: See Plans and Pricing

Patent: 2292
Estimated Expiration: See Plans and Pricing

Japan

Patent: 61488
Estimated Expiration: See Plans and Pricing

Patent: 10535759
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 178888
Estimated Expiration: See Plans and Pricing

Patent: 2017010
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0013
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 1991
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0871
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2693
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 014500053
Estimated Expiration: See Plans and Pricing

Poland

Patent: 78888
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 78888
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 435
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201508712Q
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 78888
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1000348
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1474831
Estimated Expiration: See Plans and Pricing

Patent: 1831674
Estimated Expiration: See Plans and Pricing

Patent: 100059811
Estimated Expiration: See Plans and Pricing

Patent: 140042932
Estimated Expiration: See Plans and Pricing

Patent: 140042933
Estimated Expiration: See Plans and Pricing

Patent: 150010802
Estimated Expiration: See Plans and Pricing

Patent: 160040735
Estimated Expiration: See Plans and Pricing

Patent: 170004031
Estimated Expiration: See Plans and Pricing

Spain

Patent: 90606
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 40641
Estimated Expiration: See Plans and Pricing

Patent: 11972
Estimated Expiration: See Plans and Pricing

Patent: 42594
Estimated Expiration: See Plans and Pricing

Patent: 0914460
Estimated Expiration: See Plans and Pricing

Patent: 1425320
Estimated Expiration: See Plans and Pricing

Patent: 1425321
Estimated Expiration: See Plans and Pricing

Patent: 1700482
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000060
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 536
Estimated Expiration: See Plans and Pricing

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
China 107253966 硼酸酯化合物及其医药组合物 (Boronate ester compounds and pharmaceutical compositions thereof) See Plans and Pricing
Tunisia 2010000060 PROTEASOME INHIBITORS See Plans and Pricing
Poland 1660507 See Plans and Pricing
South Africa 201000348 PROTEASOME INHIBITORS See Plans and Pricing
Australia 2004268946 Proteasome inhibitors and methods of using the same See Plans and Pricing
Malaysia 171021 BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NINLARO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2178888 1790016-8 Sweden See Plans and Pricing PRODUCT NAME: IXAZOMIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND ESTERS THEREOF, SUCH AS IXAZOMIB CITRATE; REG. NO/DATE: EU/1/16/1094 20161123
2178888 CA 2017 00014 Denmark See Plans and Pricing PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
2178888 17/2017 Austria See Plans and Pricing 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
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
2178888 C02178888/01 Switzerland See Plans and Pricing PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65959 03.02.2017
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
AstraZeneca
Medtronic
Harvard Business School
McKesson

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.