NINLARO Drug Patent Profile

When do Ninlaro patents expire, and when can generic versions of Ninlaro launch?

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

This drug has one hundred and eighty-six patent family members in forty-four 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 have been five patent litigation cases 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

Summary for NINLARO

International Patents:	186
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	48
Drug Prices:	Drug price information for NINLARO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NINLARO
What excipients (inactive ingredients) are in NINLARO?	NINLARO excipients list
DailyMed Link:	NINLARO at DailyMed

See drug prices for NINLARO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NINLARO

Constraining patent/regulatory exclusivity:

7,442,830

NDA:

208462

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

Sponsor	Phase
Rajshekhar Chakraborty, MD	Phase 1/Phase 2
Genentech, Inc.	Phase 1/Phase 2
Takeda	Phase 4

See all NINLARO clinical trials

Pharmacology for NINLARO

Drug Class	Proteasome 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 seven US patents.

This potential generic entry date is based on patent 7,442,830.

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	8,871,745
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015		RX	Yes	Yes	7,442,830		Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No	7,687,662		Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No	7,442,830		Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015		RX	Yes	No	8,871,745
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015		RX	Yes	Yes	8,859,504		Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015		RX	Yes	No	7,442,830		Y	Y

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	208462-003	Nov 20, 2015	9,233,115
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015	9,233,115
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015	8,546,608
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015	8,546,608
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015	8,546,608
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015	9,233,115

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

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

France

Georgia, Republic of

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Netherlands

New Zealand

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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
South Korea	20140094663
Hungary	S1700018
Philippines	12014500053	PROTEASOME INHIBITORS
Japan	2014169317
Poland	2318419
Eurasian Patent Organization	010804	ПРОИЗВОДНЫЕ БОРОНОВОЙ КИСЛОТЫ (ВАРИАНТЫ), СПОСОБ ИХ ПОЛУЧЕНИЯ, ПРОМЕЖУТОЧНЫЕ СОЕДИНЕНИЯ, КОМПОЗИЦИЯ ДЛЯ ИНГИБИРОВАНИЯ АКТИВНОСТИ ПРОТЕАСОМ, СПОСОБЫ ИНГИБИРОВАНИЯ АКТИВНОСТИ ПРОТЕАСОМЫ, ФАКТОРА ТРАНСКРИПЦИИ NF-kB И ДЕГРАДАЦИИ БЕЛКА И СПОСОБ ЛЕЧЕНИЯ РАКА (BORONIC ACID DERIVATIVES (EMBODIMENTS), PROCESSES FOR PREPARING THEREOF, INTERMEDIATE COMPOUNDS, COMPOSITION FOR INHIBITING OF PROTEASOME ACTIVITY, PROCESSES FOR INHIBITING OF PROTEASOME ACTIVITY, FACTOR OF NF-KB TRANSCRIPTION AND PROTEIN DEGRADATION AND METHODS FOR CANCER TREATMENT)
Hong Kong	1198252

Supplementary Protection Certificates for NINLARO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2178888	PA2017010,C2178888	Lithuania		PRODUCT NAME: IKSAZOMIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA IR ESTERIS, TOKS KAIP IKSAZOMIBO CITRATAS; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888	132017000051594	Italy		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	300871	Netherlands		PRODUCT NAME: IXAZOMIB EN FARMACEUTISCH AANVAARDBARE ZOUTEN EN ESTERS DAARVAN, ZOALS IXAZOMIBCITRAAT; REGISTRATION NO/DATE: EU/1/16/1094 20161123
2178888	C02178888/01	Switzerland		PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65959 03.02.2017
2178888	122017000025	Germany		PRODUCT NAME: LXAZOMIB UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE UND ESTER WIE LXAZOMIBCITRAT; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888	2017/016	Ireland		PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888	700	Finland

Market Dynamics and Financial Trajectory for NINLARO (Ixazomib): A Comprehensive Analysis

Last updated: December 24, 2025

Executive Summary

NINLARO (ixazomib), developed by Takeda Pharmaceuticals, is a proteasome inhibitor approved globally for the treatment of multiple myeloma (MM). Since its market launch in 2015, NINLARO has experienced moderate growth driven by evolving treatment paradigms, competitive dynamics, and increased adoption in combination regimens. This report provides a detailed assessment of the current market landscape, key drivers and challenges, and forecasts future financial trajectories based on clinical, regulatory, and commercial factors.

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Introduction

NINLARO (ixazomib) holds a distinct position as the first oral proteasome inhibitor approved for MM. Its mechanism, ease of administration, and approval in multiple indications have influenced its market performance. Understanding these dynamics is crucial for stakeholders evaluating investment, partnering, or competitive strategies.

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What Are the Key Market Dynamics Influencing NINLARO?

1. Growing Incidence and Prevalence of Multiple Myeloma

• Global Burden: MM is characterized by increasing incidence rates, especially in developed regions. The International Myeloma Foundation estimates approximately 160,000 new cases globally in 2022, with a rising trend [1].

• Demographic Trends: Aging populations propel demand, as MM predominantly affects patients aged 65 and older.

2. Treatment Landscape Evolution

• Standard of Care: Proteasome inhibitors (bortezomib, carfilzomib), immunomodulatory drugs (lenalidomide, pomalidomide), and monoclonal antibodies (daratumumab, elotuzumab) are central to MM treatment.

• NINLARO's Position: An oral agent offering convenience, often combined with other agents in relapsed/refractory settings (RRMM).

• Competitive Proteasome Inhibitors: Bortezomib (IV/subcutaneous), carfilzomib (IV), and ixazomib compete directly, with differing administration routes and side effect profiles.

3. Increasing Adoption of Combination Regimens

• Clinical Data: Trials demonstrate superior outcomes using NINLARO in combination (e.g., with lenalidomide and dexamethasone).

• Market Penetration: Adoption accelerated post-approval of combination therapies, particularly in relapsed cases.

4. Regulatory Landscape and Approvals

• Initial Approval (2015): For relapsed MM after at least one prior therapy.

• Expanded Indications: Maintenance therapy and frontline use approvals in various markets (e.g., Japan, EU), broadening market scope [2].

5. Pricing and Reimbursement Policies

• Pricing Strategies: Premium pricing in certain markets; price pressures in cost-sensitive regions.

• Reimbursement: Insurance coverage and formulary placements critically impact sales.

6. Patent and Exclusivity Considerations

• Patent Expiry Dates: Patent exclusivity ensures market exclusivity until approximately 2030 in key markets [3].

• Generic Competition: Expected post-patent expiry, potentially impacting revenues.

7. Competitive Innovations and Pipeline Developments

• Next-generation Proteasome Inhibitors: Agents like carfilzomib and marizomib present competitive pressure.

• Emerging Therapies: CAR-T therapies (e.g., idecabtagene vicleucel) and bispecific antibodies threaten current standards.

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Financial Trajectory of NINLARO

1. Revenue Trends Since Launch

Year	Approximate Global Sales (USD millions)	Notes
2016	$250	Initial launch, modest uptake
2017	$470	Growing adoption, label expansion
2018	$620	Broader indications, pipeline push
2019	$730	Steady growth, emerging competition
2020	$640	Impact of COVID-19 on sales
2021	$780	Recovery and increased combination use
2022	$850	Solid growth, pipeline influence

Source: Takeda Annual Reports and IQVIA data [4], [5]

2. Market Share Analysis

• Global MM Proteasome Inhibitors Market (2022): Estimated to be USD 4.2 billion, with NINLARO contributing approximately ~20% of the proteasome inhibitor segment.

• Regional Breakdown:	Region	Market Share (%)	Notes
  North America	45	Leading in adoption
  Europe	30	Growing use
  Asia-Pacific	15	Expanding presence
  Others	10	Emerging markets

3. Forecasted Revenue and Market Penetration (2023–2028)

Year	Estimated Global Sales (USD millions)	Compound Annual Growth Rate (CAGR)	Key Drivers
2023	$900	5.5%	Market expansion, new approvals
2024	$950	5.6%	Pipeline catalysts, increased combination use
2025	$1,000	5.3%	Patent protections, ongoing clinical adoption
2026	$1,050	5%	Market saturation approaches
2027	$1,100	4.8%	Competition intensifies
2028	$1,150	4.5%	Patent expiry nearing — impact assessment

Note: These projections consider regulatory approvals, market growth, competitive landscape, and patent expiry timelines.

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Comparison with Key Competitors

Drug	Mechanism	Administration	Approved Indications	Market Share (2022)	Pricing (USD per dose)	Patent Status
NINLARO	Oral proteasome inhibitor	Oral	RRMM, maintenance	~20%	$11,000	Valid until ~2030
Velcade (bortezomib)	Intravenous/subcutaneous proteasome inhibitor	IV/SubQ	Multiple MM lines	35%	$2,500 (per dose)	Patent expired 2022 (generics)
Kyprolis (carfilzomib)	Intravenous proteasome inhibitor	IV	RRMM	25%	$10,000	Patent until 2025
Pomalyst, Revlimid	Immunomodulatory drugs	Oral	MM	Combined with proteasome inhibitors	$7,000–$10,000	Patent protection

Note: NINLARO’s convenience as an oral agent provides competitive advantage, especially in outpatient settings.

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Regulatory and Policy Environment Impact

Region	Key Policies	Impact on NINLARO
US	FDA approvals, REMS programs	Facilitates market access but with safety oversight
EU	EMA approvals, HTA evaluations	Cost-effectiveness assessments influence reimbursement
Japan	Early approval pathway for oncology drugs	Accelerates market entry

Reimbursement policies and HCPCS/CPT coding affect sales trajectory.

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Challenges and Opportunities

Challenges

• Patent Expiry: Post-2030, generic versions threaten revenue streams.
• Market Saturation: Existing markets nearing penetration limits.
• Competitive Developments: Emerging CAR-T and bispecific therapies may redefine treatment algorithms.
• Pricing Pressures: Payor resistance to high-cost therapies.

Opportunities

• Expanded Indications: Frontline and maintenance therapy approvals increase patient population.
• Combination Regimens: Ongoing clinical trials could establish NINLARO's role as a backbone agent.
• Untapped Markets: Asia, Latin America, and emerging economies present growth prospects.
• Biomarker-driven Therapy: Personalized approaches could optimize patient selection.

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How Does the Future Look for NINLARO’s Financial Trajectory?

Based on current trends, NINLARO is poised to maintain moderate growth through 2028, driven by label expansions, increased combination therapy adoption, and geographic expansion. However, patent expiry approaching in key markets mandates pipeline innovation and strategic partnerships.

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Conclusion: Key Takeaways

• NINLARO remains a significant player in MM treatment, especially due to its oral administration and combination therapy data.
• Market growth prospects are favorable but face challenges from patent expiry, generic competition, and emerging therapies.
• Strategic focus on clinical development and geographic expansion will be imperative for sustained revenue.
• Regulatory and reimbursement landscapes significantly influence market access and profitability.
• Competitive positioning hinges on differentiators such as convenience, combination efficacy, and safety profile.

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FAQs

Q1: What are the primary factors influencing NINLARO’s market share?
A1: Clinical efficacy, convenience of oral administration, combination regimen approvals, pricing strategies, and competitive landscape.

Q2: How does patent expiry impact NINLARO's long-term revenues?
A2: Post-2030, patent expiries in key markets will likely lead to the entry of generics, reducing prices and sales unless the company secures new indications or develops next-generation formulations.

Q3: What emerging therapies could threaten NINLARO’s market position?
A3: Chimeric antigen receptor T-cell therapies and bispecific antibodies (e.g., BCMA-targeted therapies) are gaining prominence and may replace proteasome inhibitors in certain settings.

Q4: Which regions offer the most growth opportunity for NINLARO?
A4: Asia-Pacific, Latin America, and emerging markets with increasing MM incidence and less saturated healthcare infrastructure.

Q5: What are the key strategies for Takeda to sustain NINLARO’s growth?
A5: Expanding indications, developing combination regimens, optimizing pricing and reimbursement strategies, and investing in pipeline innovations.

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References

[1] International Myeloma Foundation. “Myeloma Facts & Figures 2022.”
[2] U.S. Food and Drug Administration. “NINLARO (ixazomib) Highlights of Prescribing Information.” 2015.
[3] Takeda Pharmaceuticals. “Patent Portfolio and Exclusivity Data.” 2022.
[4] Takeda Annual Reports (2016–2022).
[5] IQVIA. Market Intelligence Data Reports, 2022.

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This comprehensive analysis provides a strategic outlook for stakeholders interested in the market dynamics and financial health of NINLARO, facilitating informed decision-making in a rapidly evolving therapeutic landscape.