IXABEPILONE - Generic Drug Details

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

Ixabepilone is the generic ingredient in one branded drug marketed by R-pharm Us Llc and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ixabepilone has thirty-four patent family members in twenty-six countries.

There is one drug master file entry for ixabepilone. One supplier is listed for this compound.

Summary for IXABEPILONE

International Patents:	34
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	114
Patent Applications:	7,346
What excipients (inactive ingredients) are in IXABEPILONE?	IXABEPILONE excipients list
DailyMed Link:	IXABEPILONE at DailyMed

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

Constraining patent/regulatory exclusivity:

7,312,237*PED

Dosage:

INJECTABLE;INTRAVENOUS

^*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 IXABEPILONE

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

Sponsor	Phase
Allarity Therapeutics	Phase 2
R-Pharm US, Inc.	Phase 2
Yale University	Phase 2

See all IXABEPILONE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for IXABEPILONE

L01DC	Other cytotoxic antibiotics
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IXABEPILONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IXEMPRA KIT	Injection	ixabepilone	15 mg/vial and 45 mg/vial, single- use vials	022065	1	2012-04-16

US Patents and Regulatory Information for IXABEPILONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007		RX	Yes	Yes	7,312,237*PED				Y
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-001	Oct 16, 2007		RX	Yes	Yes	7,312,237*PED				Y

Expired US Patents for IXABEPILONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007	6,605,599
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-001	Oct 16, 2007	6,605,599
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007	RE41393*PED
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007	7,125,899*PED
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007	RE41911*PED

International Patents for IXABEPILONE

Country	Patent Number	Title	Estimated Expiration
Brazil	0207961
Estonia	200300440
Croatia	P20030831	KOMBINACIJA ANALOGA EPOTILONA I KEMOTERAPIJSKIH SREDSTAVA ZA LIJEČENJE PROLIFERATIVNIH OBOLJENJA (COMBINATION OF EPOTHILONE ANALOGS AND CHEMOTHERAPEUTIC AGENTS FOR THE TREATMENT OF PROLIFERATIVE DISEASES)
Norway	333972
European Patent Office	1383490	COMBINAISON D'UN ANALOGUE D'EPOTHILONE ET D'AGENTS CHIMIOTHERAPEUTIQUES SERVANT AU TRAITEMENT DE MALADIES PROLIFERATIVES (COMBINATION OF AN EPOTHILONE ANALOG AND CHEMOTHERAPEUTIC AGENTS FOR THE TREATMENT OF PROLIFERATIVE DISEASES)

Supplementary Protection Certificates for IXABEPILONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1019389	C01019389/01	Switzerland		PRODUCT NAME: IXABEPILONE; REGISTRATION NUMBER/DATE: SWISSMEDIC 58880 27.02.2009

IXABEPILONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ixabepilone

Market Overview

Ixabepilone, marketed under the brand name Ixempra, is a chemotherapy drug belonging to the epothilone class. It is primarily used to treat advanced or metastatic breast cancer in patients who have not responded to other treatments. Here’s a detailed look at the market dynamics and financial trajectory of ixabepilone.

Drivers of Market Growth

Increasing Incidence of Breast Cancer

The global ixabepilone market is driven by the rising incidence of breast cancer, particularly metastatic and resistant cases. Breast cancer is one of the most common forms of cancer, with approximately 10% of newly diagnosed patients presenting with metastatic disease[2].

Unmet Medical Needs

There is a significant unmet medical need for effective treatments for metastatic breast cancer, as current options often result in resistance to anthracyclines and taxanes. Ixabepilone fills this gap by providing an alternative treatment option for patients who have failed other therapies[1][2].

Aging Population

An aging population is at a higher risk of developing cancer, which contributes to the growing demand for ixabepilone. As the global population ages, the incidence of breast cancer is expected to increase, driving market growth[1].

Regulatory Approvals and Guidelines

The inclusion of ixabepilone in treatment guidelines and regulatory approvals in various regions, such as Europe and North America, has significantly boosted its market. The European Medicines Agency's approval and the FDA's approval in 2007 have been crucial in expanding its use[1][2].

Healthcare Infrastructure in Developing Nations

Better access to healthcare in developing countries, particularly in the Asia-Pacific region, is also driving the demand for ixabepilone. Countries like China, India, and Japan are improving their healthcare systems, leading to increased adoption of advanced cancer therapies[1].

Market Segmentation and Regional Analysis

Global Market Size and Forecast

The global ixabepilone market is projected to grow at a compound annual growth rate (CAGR) of a significant percentage from 2024 to 2034, reaching a substantial market size by the end of the forecast period[1][4].

Regional Performance

• North America: This region currently dominates the market with a significant share, driven by advanced healthcare infrastructure and high adoption rates of new cancer therapies[1].
• Europe: Europe's robust regulatory environment and significant research funding support the growth of the ixabepilone market. Countries like Germany, France, and the UK have well-established healthcare systems that facilitate the adoption of advanced cancer treatments[1].
• Asia Pacific: This region is expected to be the fastest-growing segment during the forecast period due to rising cancer rates and enhancing healthcare infrastructure. Countries like China, India, and Japan are key drivers of this growth[1].

Financial Trajectory

Revenue and Market Share

The ixabepilone market was valued at USD xx Million in 2024 and is expected to increase at an approximate CAGR during the forecasted period. Major companies operating in this market, such as R-Pharm, play a significant role in driving revenue and market share[1][4].

Budget Impact Analysis

A budget impact analysis for a hypothetical 1 million-member commercial plan showed that the estimated incremental cost per member per month (PMPM) for ixabepilone therapy is relatively small. For patients pretreated with anthracyclines and taxanes (AT-p), the estimated incremental cost PMPM was $0.002, and for those pretreated with anthracyclines, taxanes, and capecitabine (ATC-p), it was $0.003 to $0.004 over a three-year period[2].

Pricing Trends and Average Selling Prices

The pricing of ixabepilone is influenced by various factors, including regulatory approvals, market competition, and healthcare policies. The average selling prices (ASPs) are critical in determining the financial trajectory, with sensitivity analyses showing that the cost of ixabepilone is a key factor in budget impact models[2][4].

Key Market Players and Competitive Landscape

The ixabepilone market is dominated by a few large companies, with R-Pharm being one of the major players. These companies invest heavily in research and development, regulatory approvals, and market expansion strategies to maintain their market share and drive growth[1][4].

Challenges and Limitations

Adverse Effects

Ixabepilone is associated with typical adverse effects such as fatigue, nausea, neuropathy, and low blood cell counts. These side effects can impact patient compliance and overall market growth[1].

Regulatory Variations

Variations in regulatory frameworks across different regions can affect the approval and adoption rates of ixabepilone. This can create challenges for market expansion and uniform growth[1].

Opportunities and Future Outlook

Ongoing Research and Development

Continuous research and development in oncology, particularly in the area of tubulin inhibitors, offer opportunities for the ixabepilone market. New indications and combination therapies can expand its use and market share[3].

Expanding Healthcare Access

Improving healthcare access in developing countries and the increasing commitment to cancer research globally are expected to drive the demand for ixabepilone in the future[1].

Key Takeaways

• The ixabepilone market is driven by the increasing incidence of breast cancer, unmet medical needs, and an aging population.
• Regulatory approvals and inclusion in treatment guidelines are crucial for market growth.
• The Asia-Pacific region is expected to be the fastest-growing segment.
• Major companies like R-Pharm dominate the market.
• Adverse effects and regulatory variations are key challenges.
• Ongoing research and expanding healthcare access present future opportunities.

FAQs

1. What is ixabepilone used for?

Ixabepilone is used to treat advanced or metastatic breast cancer in patients who have not responded to other treatments, particularly those resistant to anthracyclines and taxanes[1][2].

2. How is ixabepilone administered?

Ixabepilone is administered intravenously and is often combined with other chemotherapy drugs like capecitabine[1].

3. What are the common side effects of ixabepilone?

Common side effects include fatigue, nausea, neuropathy, and low blood cell counts[1].

4. Which regions are driving the growth of the ixabepilone market?

North America currently dominates the market, while the Asia-Pacific region is expected to be the fastest-growing segment during the forecast period[1].

5. Who are the major players in the ixabepilone market?

Major companies operating in the ixabepilone market include R-Pharm and other pharmaceutical companies[1][4].

Cited Sources

1. We Market Research: Ixabepilone Market Size Share, Scope & Industry Analysis[1]
2. PubMed: Budget impact analysis of ixabepilone used according to FDA-approved indications[2]
3. News Channel Nebraska: Tubulin Inhibitors for Breast Cancer Market 2024-2032[3]
4. Cognitive Market Research: Global Ixabepilone Market Report 2024 Edition[4]