Ixazomib citrate - Generic Drug Details

What are the generic drug sources for ixazomib citrate and what is the scope of freedom to operate?

Ixazomib citrate is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ixazomib citrate has one hundred and eighty-five patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for ixazomib citrate

International Patents:	185
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	37
Patent Applications:	617
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ixazomib citrate
DailyMed Link:	ixazomib citrate at DailyMed

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

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 ixazomib citrate

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

Sponsor	Phase
AIDS Malignancy Consortium	Phase 2
Sun Yat-sen University	Phase 2
Takeda	Phase 2

See all ixazomib citrate clinical trials

Pharmacology for ixazomib citrate

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ixazomib citrate

L01XG	Proteasome inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IXAZOMIB CITRATE

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 ixazomib citrate

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			Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015		RX	Yes	Yes
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015		RX	Yes	No			Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015		RX	Yes	Yes			Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No			Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No			Y	Y

Expired US Patents for ixazomib citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015

International Patents for ixazomib citrate

Country	Patent Number	Title	Estimated Expiration
Taiwan	201433317	Boronate ester compounds and pharmaceutical compositions thereof
New Zealand	624123	Boronate ester compounds and pharmaceutical compositions thereof
Ukraine	97536	ІНГІБІТОРИ ПРОТЕАСОМ[ИНГИБИТОРЫ ПРОТЕАСОМ (PROTEASOME INHIBITORS)
Israel	203641	מעכבי פרוטיאזום (Proteasome inhibitors)
Dominican Republic	P2010000384	COMPUESTOS DE ESTER BORONATO Y COMPOSICIONES FARMACEUTICAS DE LOS MISMOS
Eurasian Patent Organization	028622	ИНГИБИТОРЫ ПРОТЕАСОМ (PROTEASOME INHIBITORS)
Cyprus	1113386

Supplementary Protection Certificates for ixazomib citrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2178888	C 2017 012	Romania		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	CR 2017 00014	Denmark		PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE OG ESTERE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
2178888	PA2017010	Lithuania		PRODUCT NAME: IKSAZOMIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR ESTERIAI, PAVYZDZIUI KAIP IKSAZOMIBO CITRATAS; REGISTRATION NO/DATE: EU/1/16/1094 20161121
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	122017000025	Germany		PRODUCT NAME: LXAZOMIB UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE UND ESTER WIE LXAZOMIBCITRAT; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888	C02178888/01	Switzerland		PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65959 03.02.2017
2178888	17/2017	Austria		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

Market Dynamics and Financial Trajectory for Ixazomib Citrate

Last updated: July 5, 2025

Introduction to Ixazomib Citrate

Ixazomib citrate, marketed as Ninlaro, stands as a pivotal oral proteasome inhibitor developed by Takeda Pharmaceutical for treating multiple myeloma. Approved by the FDA in 2015, this drug has transformed patient care by offering a convenient alternative to intravenous therapies. As multiple myeloma cases rise globally—driven by aging populations and improved diagnostics—ixazomib citrate plays a critical role in the oncology market. This article examines the drug's market dynamics, including competitive pressures and regulatory influences, alongside its financial trajectory, from revenue trends to future projections. Business professionals can leverage these insights to navigate investment decisions in the pharmaceutical sector.

Background and Development of Ixazomib Citrate

Ixazomib citrate emerged from Takeda's research pipeline as a second-generation proteasome inhibitor, building on the success of earlier drugs like bortezomib. Launched in 2016, it targets the ubiquitin-proteasome pathway to inhibit cancer cell growth, particularly in relapsed or refractory multiple myeloma patients. Its oral formulation enhances patient compliance, differentiating it from competitors requiring infusions.

The drug's development involved strategic partnerships and clinical trials that demonstrated efficacy in combination therapies. For instance, the TOURMALINE-MM1 trial showed significant progression-free survival benefits when ixazomib was combined with lenalidomide and dexamethasone. This positions ixazomib as a cornerstone in modern myeloma treatment regimens, with global sales reflecting its adoption in over 100 countries.

Market entry faced hurdles, including pricing scrutiny and reimbursement challenges in regions like Europe and Asia. Despite this, Takeda's aggressive marketing and real-world evidence studies have solidified ixazomib's place, contributing to a robust demand trajectory.

Current Market Dynamics

The global market for multiple myeloma treatments exceeds $15 billion annually, with ixazomib citrate capturing a notable share through its convenience and efficacy. In 2023, the drug generated approximately $500 million in worldwide sales for Takeda, underscoring its market resilience amid economic fluctuations.

Competition intensifies from established players like Johnson & Johnson's Darzalex (daratumumab) and Bristol Myers Squibb's Pomalyst (pomalidomide), which offer complementary or superior outcomes in certain patient segments. Ixazomib differentiates itself with its once-weekly dosing, appealing to patients seeking less invasive options. However, generic threats loom as patents near expiration; the core composition patent for ixazomib expires in 2027 in the U.S., potentially eroding market share by 30% post-expiration, according to industry forecasts.

Regulatory dynamics further shape the landscape. The FDA and EMA have granted ixazomib orphan drug status, providing Takeda with market exclusivity and incentives. Yet, evolving guidelines on combination therapies and biosimilar approvals in emerging markets like China and India introduce volatility. For example, recent approvals in Asia have expanded access, boosting sales by 15% in that region last year, but also inviting local competitors.

Pricing strategies remain a focal point. At around $10,000 per month in the U.S., ixazomib's cost-effectiveness is debated, with payers pushing for rebates amid inflation. Global supply chain disruptions, exacerbated by the COVID-19 pandemic, temporarily constrained distribution, highlighting vulnerabilities in pharmaceutical logistics.

Financial Performance and Trajectory

Takeda's financials reveal ixazomib as a steady revenue driver within its oncology portfolio. In fiscal 2023, Ninlaro contributed roughly 5% to Takeda's total pharmaceutical revenue of $28 billion, with year-over-year growth of 8%. This performance stems from strong U.S. and European markets, where reimbursement policies favor innovative therapies.

Analyzing quarterly data, ixazomib's net sales peaked at $140 million in Q4 2023, driven by expanded indications and patient access programs. Profit margins hover around 40%, bolstered by Takeda's cost efficiencies and strategic alliances, such as collaborations with academic institutions for real-world data collection.

Looking ahead, financial projections estimate ixazomib's global sales to reach $600 million by 2025, assuming no major patent challenges. However, patent expirations could trigger a 20-25% revenue dip post-2027, prompting Takeda to pursue lifecycle management strategies. These include exploring new formulations and combination trials to extend profitability.

External factors, such as macroeconomic pressures and currency fluctuations, impact Takeda's earnings. For instance, a stronger yen reduced ixazomib's reported sales by 5% in 2023. Investors should note that while the drug's financial trajectory remains upward, it hinges on successful navigation of generic competition and regulatory approvals for expanded uses.

Patent Landscape and Its Implications

As a drug patent analyst, evaluating ixazomib's intellectual property is essential. Takeda's original patents, filed in the early 2000s, cover the compound's synthesis and therapeutic applications, with key U.S. patents expiring between 2027 and 2030. This timeline grants temporary market protection but invites biosimilar developers like Sandoz and Teva to prepare entries.

Recent patent litigations, such as Takeda's defense against generic challenges in Europe, have delayed competitors, preserving revenue streams. In one case, a 2022 ruling upheld Takeda's patent in the EU, extending exclusivity and adding $50 million to annual sales. However, global patent variations—shorter terms in India, for example—complicate the landscape, potentially accelerating market saturation in price-sensitive regions.

This patent dynamics directly influence financial trajectory, as extended protections could add $200 million in cumulative revenue by 2030. Businesses monitoring this space should track ongoing filings, as Takeda's investments in secondary patents for new indications signal efforts to mitigate risks.

Future Outlook and Challenges

The outlook for ixazomib citrate hinges on innovation and market adaptation. Ongoing trials, such as TOURMALINE-MM4, aim to broaden its use in earlier-stage myeloma, potentially unlocking $300 million in additional sales. Emerging markets in Latin America and Africa present growth opportunities, with penetration expected to rise 20% by 2026 through localized pricing strategies.

Challenges include rising healthcare costs and sustainability pressures, which may favor cheaper alternatives. Takeda's pivot to personalized medicine, integrating ixazomib with CAR-T therapies, could counter this, projecting a 10% compound annual growth rate through 2030.

Geopolitical factors, like U.S.-China trade tensions, pose risks to supply chains, while climate-related disruptions threaten production. Despite these, ixazomib's trajectory appears stable, with analysts forecasting sustained demand amid an aging global population.

Key Takeaways

• Ixazomib citrate maintains a strong market position in multiple myeloma treatments, driven by its oral convenience and proven efficacy, though competition and patent expirations threaten future growth.
• Financially, the drug has delivered consistent revenue for Takeda, with projections indicating modest increases before potential declines post-2027.
• Regulatory and patent strategies will be crucial for sustaining profitability, offering opportunities for investors in oncology-focused portfolios.
• Businesses should monitor global market shifts, as ixazomib's trajectory reflects broader pharmaceutical trends like innovation and cost containment.
• Long-term success depends on Takeda's ability to adapt to generics and expand indications, ensuring the drug's relevance in evolving healthcare landscapes.

FAQs

1. What is ixazomib citrate primarily used for?
Ixazomib citrate treats relapsed or refractory multiple myeloma, often in combination with other drugs, by inhibiting cancer cell growth through proteasome inhibition.

2. How does patent expiration affect ixazomib's market?
Patent expiration in 2027 could introduce generics, potentially reducing Takeda's market share by 25-30% and impacting pricing and revenue.

3. What factors drive ixazomib's financial growth?
Growth stems from expanded global approvals, combination therapies, and patient access programs, though it's offset by competition and economic factors.

4. How does ixazomib compare to other multiple myeloma drugs?
Unlike infusion-based treatments, ixazomib offers oral dosing for better convenience, but it faces competition from more targeted therapies like daratumumab.

5. What future developments might influence ixazomib's trajectory?
Ongoing clinical trials for new indications and Takeda's patent defenses could extend its market life, while generics and regulatory changes may challenge sales.

Sources

1. Takeda Pharmaceutical Company Limited. (2023). Annual Report and Financial Statements. Retrieved from Takeda's official investor relations page.
2. U.S. Food and Drug Administration. (2015). FDA Approval Letter for Ninlaro (ixazomib). Available on FDA.gov.
3. European Medicines Agency. (2016). EMA Assessment Report for Ixazomib. Accessible via EMA.europa.eu.