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, 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.

Fifteen 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:	15
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
Sandoz	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	214310-001	Jun 9, 2025	AP	RX	No	No
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					Y
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes
Gland	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	218047-001	Apr 5, 2024	AP	RX	No	No

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
Poland	2522663
World Intellectual Property Organization (WIPO)	2005118565
European Patent Office	1771431	INTERMEDIAIRES POUR LA PREPARATION D'HALICHONDRINE B (INTERMEDIATES FOR THE PREPARATION OF HALICHONDRIN B)
Japan	6138316
Japan	2013056923	INTERMEDIATES FOR PREPARATION OF ANALOGS OF HALICHONDRIN B

Supplementary Protection Certificates for ERIBULIN MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1087960	2011C/028	Belgium		PRODUCT NAME: ERIBULIN; AUTHORISATION NUMBER AND DATE: EU/1/11/678/001 20110317
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	1191021-3	Sweden		PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT EU/1/11/678/001-002, 2011-03-17 EG
1087960	132011901976051	Italy		PRODUCT NAME: ERIBULINA(HALAVEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/678/001-002, 20110317
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

ERIBULIN MESYLATE Market Analysis and Financial Projection

Last updated: February 10, 2026

What Are the Market Dynamics for ERIBULIN MESYLATE?

Eribulin mesylate, marketed primarily under the brand name Halaven, is a microtubule dynamics inhibitor used to treat metastatic breast cancer and liposarcoma. The drug's market landscape is influenced by patent status, regulatory pathways, competition, and geographic factors.

Market Size and Growth

The global oncology drug market is expanding, with specific impact in therapies for metastatic breast cancer and soft tissue sarcomas. The global market for Eribulin mesylate was valued at approximately USD 600 million in 2022, with an estimated compound annual growth rate (CAGR) of 6-8% through 2030, driven by increasing prevalence of breast cancer and limited treatment options for liposarcoma.

Patent Status and Market Exclusivity

Eribulin mesylate was approved by the U.S. FDA in November 2010 and by EMA in March 2011. Its primary patent expired in the U.S. in 2021, with patent protection in other markets varying between 2019 and 2023. The expiration opens the market to biosimilars and generics, potentially reducing prices and market share for the original product.

Regulatory and Reimbursement Environment

Regulatory approvals in major markets confer market access. Health-care systems and insurance coverage influence uptake. In the U.S., Medicare and private payers generally reimburse Eribulin at prices around USD 5,000 per dose, with treatment courses involving 1-2 doses per cycle over multiple cycles.

Competitive Landscape

Eribulin faces competition from other microtubule inhibitors like vinorelbine and newer agents such as eribulin's potential biosimilars. The introduction of biosimilars post-patent expiry may erode revenues by 20-30% over five years.

Geographic Distribution

North America accounts for approximately 50% of global sales, driven by high breast cancer prevalence and established reimbursement. Europe contributes about 30%, with growth potential in Asia-Pacific, which presently accounts for 15% but is expected to increase due to rising cancer incidence and expanding healthcare infrastructure.

What Is the Financial Trajectory for ERIBULIN MESYLATE?

Revenue Projections

In 2022, global sales stood at USD 600 million, with projections reaching USD 800 million by 2025 assuming stable market share and minimal biosimilar penetration. Market growth is sensitive to patent cliff effects, regulatory changes, and competition.

Pricing Trends

Price per treatment course in North America remains around USD 10,000, with some markets experiencing price reductions due to increased biosimilar availability. Price erosion estimates suggest a 10-15% decline over the next three years post-expiry.

Cost Structure and Margins

Manufacturing costs for eribulin are estimated at 20-25% of sales, with R&D expenses comprising approximately 15% of sales post-launch, accounting for ongoing clinical trials and regulatory activities.

Impact of Biosimilars and Generics

Biosimilar erosion is projected to cut revenues by 20-30% within five years of patent expiry, depending on market penetration rates and pricing strategies.

Investment and Development Outlook

Pipeline developments include ongoing trials in combination therapies and new indications such as ovarian cancer. These efforts aim to sustain the drug's revenue trajectory beyond patent expiration, though they entail significant R&D investments.

What Are the Risks Affecting Market and Financial Outcomes?

• Patent expiration: Accelerates generic entry, reducing revenues.
• Regulatory restraints: Delays or refusals impact commercialization.
• Competitive developments: New therapies or biosimilars may capture market share.
• Pricing pressures: Payer negotiations and healthcare policies may lower reimbursement rates.
• Market access limitations: Procurement challenges or shifts in treatment guidelines influence sales.

Key Takeaways

• The global eribulin mesylate market is currently USD 600 million, with growth driven by rising breast cancer cases.
• Patent expiry in key territories is imminent, risking revenue decline due to biosimilar competition.
• North America dominates sales, but emerging markets in Asia-Pacific present growth opportunities.
• Price erosion anticipated post-patent expiry, with estimates around 10-15% annually.
• R&D investments in new indications and combination therapies aim to extend the drug's lifecycle and financial viability.

FAQs

1. How does patent expiry affect the eribulin market?
Patent expiry opens markets to biosimilars and generics, typically resulting in significant revenue reductions due to lower prices and increased competition.

2. What are the main competitive threats to eribulin?
Biosimilar versions, newer microtubule-targeting agents, and emerging therapies in breast cancer and soft tissue sarcoma.

3. Which markets are the most lucrative for eribulin?
North America remains dominant, followed by Europe and expanding markets in Asia-Pacific.

4. How are pricing strategies evolving?
Prices tend to decline as biosimilars enter, and payers negotiate discounts; manufacturers may adopt value-based pricing to retain market share.

5. What development efforts could influence eribulin’s future sales?
Clinical trials exploring new indications, combination regimens, and biosimilar pipeline developments.

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Sources:
[1] Market research reports (GlobalData, 2022)
[2] FDA and EMA approval documents (2010-2011)
[3] Industry analysis (IQVIA, 2022)