ERIBULIN MESYLATE - Generic Drug Details

What are the generic sources for eribulin mesylate and what is the scope of freedom to operate?

Eribulin mesylate is the generic ingredient in two branded drugs marketed by Baxter Hlthcare Corp, Gland Pharma Ltd, Jiangxi Qingfeng, Long Grove Pharms, and Eisai Inc, and is included in five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eribulin mesylate has seventy-eight patent family members in twenty-six countries.

Seven suppliers are listed for this compound.

Summary for ERIBULIN MESYLATE

International Patents:	78
US Patents:	2
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	84
Patent Applications:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ERIBULIN MESYLATE
What excipients (inactive ingredients) are in ERIBULIN MESYLATE?	ERIBULIN MESYLATE excipients list
DailyMed Link:	ERIBULIN MESYLATE at DailyMed

Recent Clinical Trials for ERIBULIN MESYLATE

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

Sponsor	Phase
Australia New Zealand Gynaecological Oncology Group	Phase 2
Merck Sharp & Dohme LLC	Phase 2
M.D. Anderson Cancer Center	Phase 1/Phase 2

See all ERIBULIN MESYLATE clinical trials

Pharmacology for ERIBULIN MESYLATE

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Anatomical Therapeutic Chemical (ATC) Classes for ERIBULIN MESYLATE

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ERIBULIN MESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HALAVEN	Injection	eribulin mesylate	1 mg/2 mL	201532	1	2019-12-20

US Patents and Regulatory Information for ERIBULIN MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Long Grove Pharms	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	214850-001	Jul 18, 2024	AP	RX	No	No
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes
Baxter Hlthcare Corp	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	217250-001	Oct 1, 2024	AP	RX	No	No
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes
Jiangxi Qingfeng	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	218281-001	Jun 28, 2024	AP	RX	No	No
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes					Y
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes

Expired US Patents for ERIBULIN MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010

International Patents for ERIBULIN MESYLATE

Country	Patent Number	Title	Estimated Expiration
China	1216051
Poland	2522663
Japan	2015061845	ハリコンドリンＢ類似体の調製用中間体 (INTERMEDIATES FOR PREPARATION OF ANALOGS OF HALICHONDRIN B)
China	108997267	用于制备软海绵素B的类似物的中间体 (INTERMEDIATES FOR PREPARATION OF HALICHONDRIN B ANALOGS)
Australia	4573999	Macrocyclic analogs and methods of their use and preparation
European Patent Office	1087960	ANALOGUES MACROCYCLIQUES, LEURS PROCEDES D'UTILISATION ET DE PREPARATION (MACROCYCLIC ANALOGS AND METHODS OF THEIR USE AND PREPARATION)
Canada	2755266	METHODES DE PREPARATION D'ANALOGUES MACROCYCLIQUES ET INTERMEDIAIRES POUR CETTE METHODE (METHODS FOR PREPARING MACROCYCLIC ANALOGS AND INTERMEDIATES FOR PREPARING SAME)

Supplementary Protection Certificates for ERIBULIN MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1087960	C201100037	Spain		PRODUCT NAME: ERIBULINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/678/001-002; DATE OF AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/678/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20110317
1087960	122011100031	Germany		PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE HIERVON, INSBESONDERE ERIBULINMESYLAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960	SPC026/2011	Ireland		SPC026/2011: 20111128, EXPIRES: 20240615
1087960	300493	Netherlands		PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960	1190021-4	Sweden		PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT; REG:NO:/DATE: EG EU/1/11/678/001-002, 2011-03-17
1087960	C300493	Netherlands		PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960	394	Finland

ERIBULIN MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Eribulin Mesylate

Introduction

Eribulin mesylate, marketed under the brand name Halaven, is a nontaxane microtubule dynamics inhibitor belonging to the halichondrin class of drugs. It is primarily used in the treatment of metastatic breast cancer and has shown promising results in various clinical trials. Here, we delve into the market dynamics and financial trajectory of eribulin mesylate.

Market Growth and Forecast

The pharmaceutical grade eribulin mesylate market has experienced rapid and substantial growth in recent years. Forecasts indicate that this expansion will continue from 2023 to 2031, driven by positive market dynamics and sustained growth rates[1].

Market Size and Segmentation

The market size of pharmaceutical grade eribulin mesylate is segmented based on type (purity ≥99% and purity <99%) and application (solution and others), as well as geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This segmentation provides a comprehensive analysis of the market's various facets[1].

Geographical Performance

The Asia-Pacific region is expected to be a significant contributor to the market growth due to increasing healthcare expenditures and a rising demand for advanced cancer treatments. North America and Europe also play crucial roles, driven by advanced healthcare infrastructure and higher adoption rates of innovative therapies[1].

Key Drivers and Restraints

Drivers

• Increasing Incidence of Breast Cancer: The rising incidence of breast cancer globally is a major driver for the eribulin mesylate market. As more patients seek effective treatments, the demand for eribulin mesylate is expected to increase.
• Efficacy and Safety Profile: Clinical trials have demonstrated that eribulin mesylate has a comparable efficacy to traditional chemotherapy options and a manageable safety profile, which enhances its market appeal[4][5].

Restraints

• High Cost: Eribulin mesylate is a costly treatment, which can limit its accessibility in some regions, particularly in developing countries.
• Side Effects: While the safety profile is manageable, common adverse events such as asthenia or fatigue, neutropenia, alopecia, and peripheral neuropathy can affect patient compliance and market growth[4].

Financial Performance and Projections

Revenue Forecast

The market for pharmaceutical grade eribulin mesylate is projected to see significant revenue growth from 2023 to 2031. The report forecasts that the market will continue its upward trend, driven by increasing demand and expanding geographical reach[1].

Key Players and Market Share

Companies such as Natco Pharma Ltd, Emcure Pharmaceuticals Ltd, Dr Reddys Laboratories Ltd, and others are key players in the eribulin mesylate market. These companies are investing heavily in research and development to improve the purity and efficacy of eribulin mesylate, which is expected to drive market growth[1].

Clinical Efficacy and Outcomes

Comparative Efficacy

Eribulin mesylate has demonstrated comparable efficacy to traditional chemotherapy options in patients with HER2-low or HER2-0 metastatic breast cancer. Studies have shown trends toward improved outcomes in terms of overall survival (OS) and progression-free survival (PFS) when compared to other chemotherapeutic controls[5].

Quality of Life and Safety

Clinical trials have indicated that eribulin mesylate maintains a high quality of life for patients, with global health status and overall quality-of-life scores similar to those of other treatments. The safety profile, while manageable, includes common adverse events that are clinically acceptable[4].

Market Opportunities and Challenges

Opportunities

• Expanding Indications: There is potential for eribulin mesylate to be approved for additional indications beyond metastatic breast cancer, which could expand its market.
• Emerging Markets: Growing healthcare infrastructure in emerging markets presents opportunities for increased market penetration.

Challenges

• Regulatory Hurdles: Strict regulatory requirements and the need for continuous clinical trials to maintain approval can be challenging.
• Competition: The market for breast cancer treatments is highly competitive, with various other drugs and therapies available, which can impact market share[1].

Pricing and Penetration

Pricing Analysis

The pricing of eribulin mesylate is a critical factor influencing its market dynamics. High pricing can limit accessibility, while competitive pricing can enhance market penetration. The report includes a detailed pricing analysis to understand the impact on market outcomes[1].

Product Penetration

The extent of product penetration at national and regional levels is crucial. Factors such as national GDP, market dynamics, and consumer behavior influence the penetration of eribulin mesylate in different regions[1].

Competitive Landscape

The eribulin mesylate market is characterized by a mix of established and emerging players. Companies like Natco Pharma Ltd, Emcure Pharmaceuticals Ltd, and Dr Reddys Laboratories Ltd are prominent in the market. The report provides detailed profiles of these companies, including their market entry year and various market-related factors[1].

Porter's 5 Forces Framework

Threat of New Entrants

The threat of new entrants is moderate due to the high barriers to entry, including stringent regulatory requirements and significant research and development costs.

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low as there are multiple suppliers for the raw materials needed to produce eribulin mesylate.

Bargaining Power of Buyers

The bargaining power of buyers is moderate, influenced by the availability of alternative treatments and the cost of the drug.

Threat of Substitute Products

The threat of substitute products is high due to the presence of other chemotherapy options and emerging therapies.

Competitive Rivalry Among Existing Competitors

The competitive rivalry is high, driven by the presence of multiple players and the need to differentiate products through innovation and pricing strategies[1].

Conclusion

The market for eribulin mesylate is poised for significant growth driven by its efficacy, manageable safety profile, and expanding geographical reach. However, it faces challenges such as high costs, regulatory hurdles, and competition from other treatments.

Key Takeaways

• Rapid Market Growth: The eribulin mesylate market is expected to grow substantially from 2023 to 2031.
• Clinical Efficacy: Eribulin mesylate has demonstrated comparable efficacy to traditional chemotherapy options.
• Safety Profile: The drug has a manageable safety profile with common adverse events.
• Market Segmentation: The market is segmented by type, application, and geographical regions.
• Key Players: Companies like Natco Pharma Ltd and Emcure Pharmaceuticals Ltd are key players in the market.

FAQs

What is eribulin mesylate used for?

Eribulin mesylate is primarily used in the treatment of metastatic breast cancer, particularly in patients with HER2-low or HER2-0 disease.

What are the common side effects of eribulin mesylate?

Common side effects include asthenia or fatigue, neutropenia, alopecia, and peripheral neuropathy.

How does eribulin mesylate compare to traditional chemotherapy?

Eribulin mesylate has demonstrated a trend toward improved outcomes in terms of overall survival and progression-free survival compared to traditional chemotherapy options.

What are the key drivers of the eribulin mesylate market?

Key drivers include the increasing incidence of breast cancer, the drug's efficacy and safety profile, and expanding geographical reach.

Who are the major players in the eribulin mesylate market?

Major players include Natco Pharma Ltd, Emcure Pharmaceuticals Ltd, Dr Reddys Laboratories Ltd, and others.

Sources

1. Market Research Intellect, "Global Pharmaceutical Grade Eribulin Mesylate Market Size, Trends, and Forecast 2023-2031."
2. OncologyPRO, "Real-world activity of sacituzumab govitecan for metastatic breast cancer."
3. Market Research Intellect, "Ureter Cancer Drugs Market Size And Forecast."
4. Journal of Clinical Oncology, "Phase III Open-Label Randomized Study of Eribulin Mesylate Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer."
5. OncLive, "Eribulin Demonstrates Comparable Efficacy to Traditional Chemotherapy Options in HER2-Low and HER2-0 Metastatic Breast Cancer."