Eribulin mesylate - Generic Drug Details

What are the generic drug sources for eribulin mesylate and what is the scope of patent protection?

Eribulin mesylate is the generic ingredient in two branded drugs marketed by Baxter Hlthcare Corp, Chia Tai Tianqing, Dr Reddys, Gland, Glenmark Pharms Inc, Jiangxi Kvvit Pharm, Long Grove Pharms, Sandoz, and Eisai Inc, and is included in nine NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Eribulin mesylate has thirty-eight patent family members in fourteen countries.

Fourteen suppliers are listed for this compound.

Summary for eribulin mesylate

International Patents:	38
US Patents:	1
Tradenames:	2
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	85
Patent Applications:	2,140
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
National Cancer Institute (NCI)	PHASE1
Australia New Zealand Gynaecological Oncology Group	Phase 2
Merck Sharp & Dohme LLC	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
Jiangxi Kvvit Pharm	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	218281-001	Jun 28, 2024	AP	RX	No	No
Chia Tai Tianqing	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	218743-001	Mar 4, 2025	AP	RX	No	No
Dr Reddys	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	217473-001	Jul 3, 2025	AP	RX	No	No
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
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	109180615	用于制备软海绵素B的类似物的中间体 (Intermediates for preparation of analogs of halichondrin B)
Japan	2016183171	ハリコンドリンＢ類似体の調製用中間体 (INTERMEDIATES FOR PREPARATION OF HALICHONDRIN B ANALOGS)
Slovenia	2522663

Supplementary Protection Certificates for eribulin mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1087960	SPC/GB11/039	United Kingdom		PRODUCT NAME: ERIBULIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: UK EU/1/11/678/001 20110317; UK EU/1/11/678/002 20110317
1087960	91854	Luxembourg		PRODUCT NAME: ERIBULIN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (HALAVEN ); AUTHORISATION NUMBER AND DATE: EU/1/11/678/001-002, 17.03.2011
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	122011100031	Germany		PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE HIERVON, INSBESONDERE ERIBULINMESYLAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317

Market Dynamics and Financial Trajectory for Eribulin Mesylate

Last updated: July 28, 2025

Introduction

Eribulin mesylate, marketed under the brand name Halaven among others, is a novel microtubule dynamics inhibitor approved primarily for the treatment of metastatic breast cancer and liposarcoma. Developed by Eisai Co., Ltd., this drug exemplifies targeted oncology therapies that have reshaped cancer treatment paradigms. Its market evolution reflects complex dynamics involving clinical efficacy, regulatory pathways, competitive landscape, and evolving healthcare economics. This comprehensive analysis explores the current market landscape, growth drivers, challenges, and financial forecasts influencing eribulin mesylate’s trajectory over the coming years.

Pharmacological Profile and Therapeutic Indications

Eribulin mesylate offers a unique mechanism of action by inhibiting microtubule polymerization, leading to cell cycle arrest and apoptosis in cancerous tissues. Approved by the U.S. Food and Drug Administration (FDA) in 2010 for metastatic breast cancer patients who have previously received anthracyclines and taxanes, its approval has since expanded to include treatment for liposarcoma, a rare sarcoma subtype, in 2016 (FDA, 2010; 2016). This dual indication positions eribulin as a valuable asset in oncology's arsenal, targeting both prevalent and rare cancers.

Market Drivers

1. Unmet Medical Needs and Clinical Efficacy:
Eribulin's demonstrated survival benefits and manageable safety profile sustain its clinical relevance. In pivotal trials, notably the EMBRACE study, eribulin significantly improved overall survival in heavily pretreated metastatic breast cancer patients, a population with limited therapeutic options (Cameron et al., 2010). Its approval for liposarcoma – a malignancy with limited effective therapies – further bolsters its market appeal.

2. Expanding Patient Access and Reimbursement:
Healthcare policy shifts favoring targeted oncology treatments support eribulin’s adoption. Reimbursement frameworks increasingly recognize the value of extending survival, especially in metastatic settings, underpinning sales growth.

3. Geographic Expansion and New Indications:
Eisai’s strategic efforts to penetrate emerging markets, including Asia and parts of Europe, contribute to expanding the drug’s geographical footprint. Additionally, ongoing clinical trials exploring eribulin’s efficacy in other solid tumors could unlock novel indications, amplifying its market potential.

4. Strategic Partnerships and Licensing:
Partnerships with regional distributors and licensing agreements facilitate broader access and market penetration. For instance, collaborations with local pharmaceutical firms in Asia may stimulate sales volume.

Market Challenges

1. Competitive Oncology Landscape:
Eribulin faces competition from other microtubule inhibitors like taxanes and vinca alkaloids, as well as newer targeted agents and immunotherapies. For metastatic breast cancer, CDK4/6 inhibitors and antibody-drug conjugates (e.g., trastuzumab deruxtecan) pose significant competition.

2. Pricing and Reimbursement Pressures:
The high cost of eribulin presents reimbursement challenges amid global cost-containment policies. Payers’ increasing scrutiny of oncology drug prices may dampen market expansion, especially in cost-sensitive markets.

3. Regulatory and Clinical Trial Risks:
Future label expansions depend on successful clinical trial outcomes. Negative or inconclusive results may curtail growth prospects.

4. Manufacturing and Supply Chain Considerations:
Complex synthesis and supply chain intricacies could impact availability and cost, influencing profitability.

Financial Trajectory and Market Outlook

1. Current Market Size and Revenue Estimates:
As of 2022, global eribulin sales are estimated in the range of $500 million to $700 million annually, predominantly driven by North America, Europe, and Japan (IQVIA, 2022). The drug’s niche positioning in metastatic breast cancer and liposarcoma sustains steady revenue streams, albeit with modest growth.

2. Forecasted Growth Trends:
Analysts project a compound annual growth rate (CAGR) of approximately 4-6% over the next five years. This moderate growth reflects increasing adoption in existing markets and gradual expansion into emerging regions. The anticipated launch of biosimilars or copycat versions post-patent expiry could pressure prices and margins but may also expand access, particularly in low-income regions.

3. Impact of New Clinical Indications:
If ongoing trials demonstrate efficacy in additional tumor types—such as other soft tissue sarcomas, ovarian, or lung cancers—eribulin could experience accelerated sales growth. Regulatory approvals for such indications could add billions to its market valuation.

4. Patent Status and Generic Competition:
Eisai maintains patent protections until approximately 2030. The expiration of exclusivity would likely introduce generics, impacting pricing strategies and revenue streams. Strategic preparations for patent cliff scenarios include diversifying indications and exploring combination therapies.

5. Financial Performance and Investment Trends:
Eisai's investment in eribulin R&D remains strategic, with a focus on phase III trials and real-world evidence collection. The drug’s revenue performance aligns with broader oncology portfolio strategies, influencing R&D allocations and marketing efforts.

Market Dynamics: Key Factors Shaping Eribulin's Future

• Regulatory Environment: Stringent approval processes and reimbursement policies universally influence commercialization. Countries with evolving oncology treatment guidelines, such as China and India, offer both challenges and opportunities.

• Healthcare Economics: Rising healthcare costs accelerate the push for cost-effective therapies. Eribulin’s positioning as a treatment offering survival benefits in late-line settings influences payer decision-making.

• Innovation and Pipeline Development: Continued investment in clinical trials could expand eribulin’s label and improve its competitive position. Combination therapies with immunotherapies, for example, might rejuvenate interest and utility.

• Patient Demographics and Disease Epidemiology: Aging populations and increasing cancer incidence globally expand the pool of eligible patients. The rising prevalence of metastatic breast cancer and liposarcoma sustains long-term demand.

Conclusion

Eribulin mesylate’s market trajectory remains cautiously optimistic. Its success hinges on clinical differentiation, strategic geographic expansion, and navigating competitive pressures. While current revenues are steady, potential indications and combination therapies offer pathways for significant growth. Recognizing the expiration of patent exclusivity and the evolving oncology landscape, stakeholders must adapt strategies to sustain and enhance eribulin’s market positioning.

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Key Takeaways

• Eribulin mesylate has established a strong foothold within niche oncology markets, especially metastatic breast cancer and liposarcoma, driven by demonstrable survival benefits.

• Market growth is moderate, forecasted at a CAGR of 4-6%, supported by geographic expansion, new indications, and clinical pipeline progress.

• Competitive pressures from established and emerging therapies pose significant challenges, especially concerning treatment costs and reimbursement budgets.

• The expiration of intellectual property rights post-2030 could substantially impact revenue streams, underscoring the necessity for diversification and pipeline development.

• Strategic collaborations, regulatory navigation, and emerging combination regimens will determine eribulin’s long-term financial trajectory amid a dynamic oncology landscape.

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FAQs

1. What are the primary factors influencing eribulin mesylate’s market growth?
Clinical efficacy, geographic expansion, regulatory approvals for new indications, reimbursement policies, and competitive landscape are key drivers. Ongoing trials and potential combination therapies also influence future growth.

2. How does eribulin compare with other microtubule inhibitors?
Unlike taxanes and vinca alkaloids, eribulin inhibits microtubule dynamics by a distinct mechanism, offering benefits for heavily pretreated patients. Its efficacy in metastatic breast cancer and liposarcoma has positioned it uniquely, though competition remains from newer agents.

3. What is the impact of patent expiration on eribulin’s market?
Patent expiry around 2030 risks generic entry, which could substantially reduce prices and revenues, prompting Eisai to explore new indications and combination strategies to sustain market share.

4. Are there ongoing clinical trials expanding eribulin’s therapeutic applications?
Yes. Trials are investigating eribulin in other solid tumors, including ovarian and non-small cell lung cancers, with potential to broaden its indications and market scope pending trial outcomes.

5. What are the main challenges facing eribulin’s commercial success?
Pricing pressures, reimbursement hurdles, competition from targeted and immunotherapies, and regulatory risks in new markets challenge its growth trajectory.

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References

[1] FDA. (2010). FDA approves halaven to treat metastatic breast cancer.
[2] FDA. (2016). FDA approves Halaven for liposarcoma.
[3] IQVIA. (2022). Oncology Market Dynamics Report.
[4] Cameron, D., et al. (2010). EMBRACE Study on Eribulin in metastatic breast cancer. Journal of Clinical Oncology.