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Last Updated: February 11, 2025

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

See all NINLARO clinical trials

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 for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

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

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 for Free ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-002 Nov 20, 2015 RX Yes No ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-001 Nov 20, 2015 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-001 Nov 20, 2015 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-002 Nov 20, 2015 RX Yes No ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>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 ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-001 Nov 20, 2015 ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-002 Nov 20, 2015 ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-001 Nov 20, 2015 ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 ⤷  Try for Free ⤷  Try for Free
>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: ⤷  Try for Free

Australia

Patent: 07357338
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 0721905
Patent: INIBIDORES DE PROTEASSOMA
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 95082
Patent: INHIBITEURS DE PROTEASOMES (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Try for Free

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: ⤷  Try for Free

China

Patent: 1772507
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Try for Free

Patent: 2961387
Patent: Proteasome inhibitor
Estimated Expiration: ⤷  Try for Free

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: ⤷  Try for Free

Croatia

Patent: 0120745
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 13386
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 78888
Estimated Expiration: ⤷  Try for Free

Ecuador

Patent: 10010015
Patent: INHIBIDORES DE PROTEASOMA
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 8622
Patent: ИНГИБИТОРЫ ПРОТЕАСОМ (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Try for Free

Patent: 1070247
Patent: ИНГИБИТОРЫ ПРОТЕАСОМ
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 78888
Patent: INHIBITEURS DE PROTÉASOMES (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Try for Free

Patent: 27347
Patent: Inhibiteurs de protéasome (Proteasome inhibitors)
Estimated Expiration: ⤷  Try for Free

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

France

Patent: C1011
Estimated Expiration: ⤷  Try for Free

Georgia, Republic of

Patent: 0125599
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 43595
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Try for Free

Patent: 82924
Patent: 蛋白酶體抑制劑 (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 700018
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 3641
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷  Try for Free

Patent: 2290
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷  Try for Free

Patent: 2291
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷  Try for Free

Patent: 2292
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 61488
Estimated Expiration: ⤷  Try for Free

Patent: 10535759
Estimated Expiration: ⤷  Try for Free

Lithuania

Patent: 178888
Estimated Expiration: ⤷  Try for Free

Patent: 2017010
Estimated Expiration: ⤷  Try for Free

Luxembourg

Patent: 0013
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 1991
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Try for Free

Netherlands

Patent: 0871
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 2693
Patent: Boron-containing proteasome inhibitors
Estimated Expiration: ⤷  Try for Free

Philippines

Patent: 014500053
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 78888
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 78888
Estimated Expiration: ⤷  Try for Free

Serbia

Patent: 435
Patent: INHIBITORI PROTEAZOMA (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 201508712Q
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 78888
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 1000348
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1474831
Estimated Expiration: ⤷  Try for Free

Patent: 1831674
Estimated Expiration: ⤷  Try for Free

Patent: 100059811
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Try for Free

Patent: 140042932
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Try for Free

Patent: 140042933
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Try for Free

Patent: 150010802
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Try for Free

Patent: 160040735
Patent: 프로테아좀 억제제 (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Try for Free

Patent: 170004031
Patent: 프로테아좀 억제제 (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 90606
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 40641
Estimated Expiration: ⤷  Try for Free

Patent: 11972
Estimated Expiration: ⤷  Try for Free

Patent: 42594
Estimated Expiration: ⤷  Try for Free

Patent: 0914460
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Try for Free

Patent: 1425320
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Try for Free

Patent: 1425321
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Try for Free

Patent: 1700482
Patent: Proteasome inhibitors
Estimated Expiration: ⤷  Try for Free

Tunisia

Patent: 10000060
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷  Try for Free

Ukraine

Patent: 536
Patent: ІНГІБІТОРИ ПРОТЕАСОМ[ИНГИБИТОРЫ ПРОТЕАСОМ (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷  Try for Free

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 ⤷  Try for Free
Germany 602004022424 ⤷  Try for Free
China 101772507 Proteasome inhibitors ⤷  Try for Free
Netherlands 300871 ⤷  Try for Free
South Korea 101704694 ⤷  Try for Free
Portugal 2730581 ⤷  Try for Free
Singapore 194349 BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NINLARO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2178888 275 50004-2017 Slovakia ⤷  Try for Free PRODUCT NAME: IXAZOMIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1094 20161123
2178888 SPC/GB17/030 United Kingdom ⤷  Try for Free 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 C02178888/01 Switzerland ⤷  Try for Free PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65959 03.02.2017
2178888 LUC00013 Luxembourg ⤷  Try for Free 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 122017000025 Germany ⤷  Try for Free PRODUCT NAME: LXAZOMIB UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE UND ESTER WIE LXAZOMIBCITRAT; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888 C20170014 00227 Estonia ⤷  Try for Free PRODUCT NAME: IKSASOMIIB;REG NO/DATE: EU/1/16/1094 23.11.2016
2178888 17C1011 France ⤷  Try for Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for NINLARO

Introduction

NINLARO (ixazomib), developed by Takeda Pharmaceutical Co., is a groundbreaking oral proteasome inhibitor that has significantly impacted the treatment landscape for multiple myeloma. Here, we delve into the market dynamics and financial trajectory of NINLARO, highlighting its performance, competitive position, and future prospects.

Market Approval and Initial Launch

NINLARO was the first orally active proteasome inhibitor to reach the market, gaining FDA approval in 2015 for the treatment of adult patients with multiple myeloma who have received at least one prior therapy, in combination with lenalidomide and dexamethasone[5].

Early Adoption and Market Share

Following its launch, NINLARO quickly gained traction. By just a few months after its introduction in the U.S., it captured a significant market share, with one in five new patients receiving second-line treatment for multiple myeloma being prescribed the drug. This was the highest market share for any new multiple myeloma therapy at the time[1].

Global Expansion

NINLARO's approval extended beyond the U.S., with approvals in Canada, Israel, Venezuela, and a filing in Japan. The EU's Committee for Medicinal Products for Human Use (CHMP) also reversed an earlier decision to reject NINLARO, paving the way for a potential launch in early 2017[1].

Financial Performance

Initial Sales

In the first six months of its fiscal year, NINLARO generated ¥13 billion (approximately $125 million) in sales, contributing significantly to the growth of Takeda's U.S. business. Despite a limited label claim, NINLARO accounted for one-third of the growth in the U.S. market[1].

Growth Trajectory

By FY 2019, NINLARO's sales had grown to $721 million, representing a 24.7% increase from the previous year. This growth continued into the first quarter of FY 2020, with sales increasing by another 25.3% to $213 million. The COVID-19 pandemic played a role in this growth, as NINLARO's oral administration was more convenient than injectable competitors[2].

Competitive Landscape

Market Position

NINLARO competes in the proteasome inhibitors market, which includes other notable drugs like Velcade (bortezomib) and Kyprolis (carfilzomib). As of 2018, NINLARO commanded over 11% of the proteasome inhibitors volume share, while Velcade dominated with over 54% of the market[4].

Comparative Efficacy

Clinical studies have shown that the NINLARO treatment combination (NINLARO + lenalidomide + dexamethasone) significantly prolongs progression-free survival (PFS) compared to lenalidomide and dexamethasone alone. Patients on the NINLARO combination experienced a PFS of 20.6 months, compared to 14.7 months for those on the two-drug combination[3][5].

Future Prospects

Projected Sales

Takeda's CEO, Christophe Weber, has expressed strong confidence in NINLARO's potential, predicting it will become a "$3 billion-plus product" and a cornerstone in multiple myeloma treatment. This projection is supported by ongoing Phase III trials aimed at moving NINLARO into first-line treatment[1].

Market Expansion

NINLARO's growth is also driven by its convenience and the ongoing research in diverse patient populations. The drug is expected to witness considerable growth during the forecast period, contributing to the overall expansion of the proteasome inhibitors market[4].

Challenges and Opportunities

Patent Expiry of Velcade

Takeda faces a significant challenge with the impending loss of U.S. patent protection for Velcade, its flagship multiple myeloma drug. However, NINLARO's strong performance is positioned to fill this revenue gap, ensuring continued growth for Takeda in the multiple myeloma market[1].

Competitive Pressure

The multiple myeloma market is highly competitive, with drugs like Darzalex (daratumumab) from Johnson & Johnson posing stiff competition. However, NINLARO's unique oral administration and proven efficacy profile help it maintain a strong market position[1].

Conclusion

NINLARO has established itself as a pivotal treatment in the multiple myeloma landscape, driven by its efficacy, convenience, and strong market adoption. With projected sales exceeding $3 billion and ongoing clinical trials to expand its use into first-line treatment, NINLARO is set to become one of the leading drugs in its class.

Key Takeaways

  • Market Approval: NINLARO was the first oral proteasome inhibitor approved for multiple myeloma treatment.
  • Early Adoption: It quickly gained significant market share in the U.S. and globally.
  • Financial Performance: NINLARO showed strong sales growth, contributing substantially to Takeda's revenue.
  • Competitive Landscape: NINLARO competes with Velcade and Kyprolis but has a unique advantage due to its oral administration.
  • Future Prospects: Projected to become a $3 billion-plus product, with ongoing trials for first-line treatment.

FAQs

Q: What is NINLARO used for? A: NINLARO (ixazomib) is used for the treatment of adult patients with multiple myeloma who have received at least one prior therapy, in combination with lenalidomide and dexamethasone.

Q: How does NINLARO compare to other proteasome inhibitors? A: NINLARO is the first oral proteasome inhibitor and has shown significant efficacy in prolonging progression-free survival compared to other treatments like Velcade and Kyprolis.

Q: What are the key financial milestones for NINLARO? A: By FY 2019, NINLARO's sales reached $721 million, and it continued to grow by 25.3% in the first quarter of FY 2020.

Q: What challenges does Takeda face with NINLARO? A: Takeda faces the challenge of Velcade's patent expiry but is well-positioned with NINLARO to fill the revenue gap.

Q: What are the future prospects for NINLARO? A: NINLARO is projected to become a $3 billion-plus product, with ongoing Phase III trials aimed at expanding its use into first-line treatment.

Sources

  1. FiercePharma: Takeda CEO says new myeloma drug Ninlaro will be 'significantly bigger than Velcade'[1].
  2. PharmaLive: Takeda 2020: The incredible growing/shrinking pharma[2].
  3. Ninlaro.com: Results with NINLARO® (ixazomib)[3].
  4. Biospace: Proteasome Inhibitors Market Size Worth $1.7 Billion by 2023[4].
  5. Health Canada: Summary Basis of Decision for Ninlaro[5].

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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.