IXAZOMIB CITRATE - Generic Drug Details

What are the generic sources for ixazomib citrate and what is the scope of patent protection?

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

Ixazomib citrate has two hundred and twenty-four patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for IXAZOMIB CITRATE

International Patents:	224
US Patents:	9
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	208462-002	Nov 20, 2015		RX	Yes	No
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015		RX	Yes	No
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015		RX	Yes	Yes
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015		RX	Yes	No

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	208462-003	Nov 20, 2015
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

International Patents for IXAZOMIB CITRATE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1244827	硼酸酯化合物及其醫藥組合物 (BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF)
Poland	1660507
Taiwan	I498333
Spain	2541467
Israel	217623	תרכובת אמינו-קרבוניל-בורונית מותמרת (Substituted amino-carbonyl-boronic compound)

Supplementary Protection Certificates for IXAZOMIB CITRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C02178888/01	Switzerland		PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65959 03.02.2017
2178888	CA 2017 00014	Denmark		PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
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	700	Finland

IXAZOMIB CITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ixazomib Citrate

Market Overview

Ixazomib citrate, marketed under the brand name Ninlaro, is a potent, reversible, and selective small molecule inhibitor of the 20S proteasome. It is primarily used in the treatment of multiple myeloma, a malignancy of the plasma cells in the bone marrow. Here’s a detailed look at the market dynamics and financial trajectory of ixazomib citrate.

Global Market Growth

The ixazomib citrate market is projected to grow at a significant compound annual growth rate (CAGR) from 2024 to 2034. This growth is driven by several key factors, including the increasing prevalence of multiple myeloma, advancements in cancer therapies, and improved diagnostic techniques[1].

Regional Market Performance

North America

North America dominates the ixazomib citrate market, accounting for more than 46% of the global revenue. This dominance is attributed to a highly developed healthcare infrastructure, substantial investment in cancer research, and favorable healthcare policies and reimbursement models[1].

Europe

Europe is another significant market for ixazomib citrate, with countries like Germany, the UK, France, Italy, Spain, and Russia contributing to the regional growth. The market here is influenced by well-established healthcare systems and varying reimbursement models across different countries[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. This rapid growth is fueled by increasing healthcare investments, rising awareness of multiple myeloma, and favorable government initiatives. Improvements in healthcare infrastructure also play a crucial role in this region's market expansion[1].

Key Market Drivers

Increasing Prevalence of Multiple Myeloma

The growing number of cases of multiple myeloma is a primary driver of the ixazomib citrate market. As the global population ages, the incidence of this disease is expected to rise, thereby increasing the demand for effective treatments like ixazomib citrate[1].

Advancements in Cancer Therapies

Advancements in cancer therapies, including the development of proteasome inhibitors like ixazomib, are driving the market. The oral mode of administration of ixazomib citrate offers a more convenient alternative to injectable forms, enhancing patient compliance and treatment outcomes[1].

Favorable Healthcare Policies and Reimbursement Models

Favorable healthcare policies and reimbursement models significantly impact the market. In regions where these policies are supportive, the accessibility and affordability of ixazomib citrate increase, contributing to market growth[1].

Financial Implications

Cost and Reimbursement

Ixazomib citrate is associated with a significant cost, with the total wholesale acquisition cost for one cycle estimated at $9,942. However, the average reimbursement per cycle is around $9,205, making it a financially acceptable alternative for the treatment of multiple myeloma compared to other proteasome inhibitors like bortezomib[2].

Comparison with Other Treatments

In a comparative study, ixazomib was found to have similar drug reimbursement rates to bortezomib but slightly higher rates of interruption in therapy. Despite this, ixazomib remains a viable option due to its oral administration and comparable efficacy[2].

Market Challenges

Regulatory Variations

The market is influenced by diverse healthcare policies and reimbursement models across different countries, which can lead to variations in growth rates. Harmonizing regulations and improving access to treatments are crucial for enhancing market stability and expansion[1].

Therapy Interruptions

Ixazomib is associated with a slightly higher incidence of interruption in therapy compared to bortezomib. This can impact patient compliance and overall treatment outcomes, necessitating careful management and monitoring[2].

Key Market Players

The ixazomib citrate market is dominated by a few large companies, including Msn Laboratories Private Ltd and Sun Pharmaceutical Industries Ltd. Strategic alliances between pharmaceutical companies and research universities can further enhance market expansion and innovation[1].

Clinical and Pharmacological Aspects

Dosage and Administration

Ixazomib citrate is administered orally, typically in combination with lenalidomide and dexamethasone. The recommended starting dose is 4 mg once a week on Days 1, 8, and 15 of a 28-day treatment cycle. Dose modifications are recommended for hematological toxicities[3].

Efficacy and Safety

Clinical trials have shown that ixazomib citrate offers significant efficacy in treating multiple myeloma, with median progression-free survival (PFS) and overall survival (OS) rates that are comparable to other proteasome inhibitors. However, it is associated with hematological toxicities, which require careful monitoring and dose adjustments[5].

Future Outlook

The future of the ixazomib citrate market looks promising, driven by ongoing research and clinical trials that continue to increase the drug's awareness and acceptance. Improvements in healthcare infrastructure and favorable government initiatives, especially in the Asia Pacific region, are expected to further boost market growth.

Key Takeaways

• The ixazomib citrate market is driven by the increasing prevalence of multiple myeloma and advancements in cancer therapies.
• North America dominates the market, but the Asia Pacific region is expected to be the fastest-growing segment.
• Favorable healthcare policies and reimbursement models play a crucial role in market growth.
• Ixazomib citrate offers a financially acceptable alternative to other proteasome inhibitors despite slightly higher rates of therapy interruption.
• Strategic alliances and ongoing research are key to further market expansion.

Frequently Asked Questions (FAQs)

What is ixazomib citrate used for?

Ixazomib citrate is used in the treatment of multiple myeloma, a malignancy of the plasma cells in the bone marrow, particularly in patients who have received at least one prior therapy[3].

How is ixazomib citrate administered?

Ixazomib citrate is administered orally, typically in combination with lenalidomide and dexamethasone, once a week on Days 1, 8, and 15 of a 28-day treatment cycle[3].

What are the key drivers of the ixazomib citrate market?

The key drivers include the increasing prevalence of multiple myeloma, advancements in cancer therapies, favorable healthcare policies, and improvements in healthcare infrastructure[1].

Which region is expected to be the fastest-growing segment for ixazomib citrate?

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period, driven by increasing healthcare investments and favorable government initiatives[1].

What are the financial implications of using ixazomib citrate?

Ixazomib citrate has a significant cost, but it is financially acceptable due to similar reimbursement rates to other proteasome inhibitors like bortezomib. However, it has slightly higher rates of therapy interruption[2].

Cited Sources:

1. We Market Research: Ixazomib Citrate Market Overview & Key Trends 2024-2034.
2. PubMed: Medication use evaluation of the financial and clinical implications of ixazomib.
3. TGA: Extract from the Clinical Evaluation Report for Ixazomib citrate.
4. 360iResearch: Ixazomib Citrate Capsules Market Size & Share 2025-2030.
5. Synapse: Ixazomib citrate - Drug Targets, Indications, Patents.