HALAVEN Drug Patent Profile

When do Halaven patents expire, and when can generic versions of Halaven launch?

Halaven is a drug marketed by Eisai Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-eight patent family members in fourteen countries.

The generic ingredient in HALAVEN is eribulin mesylate. Fifteen suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Halaven

A generic version of HALAVEN was approved as eribulin mesylate by GLAND on April 5^th, 2024.

Summary for HALAVEN

International Patents:	38
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	63
Patent Applications:	1,272
Drug Prices:	Drug price information for HALAVEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HALAVEN
What excipients (inactive ingredients) are in HALAVEN?	HALAVEN excipients list
DailyMed Link:	HALAVEN at DailyMed

See drug prices for HALAVEN

Recent Clinical Trials for HALAVEN

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

Sponsor	Phase
Shantou Central Hospital	Phase 2
Guangdong Provincial People's Hospital	Phase 2
First Affiliated Hospital, Sun Yat-Sen University	Phase 2

See all HALAVEN clinical trials

Pharmacology for HALAVEN

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Paragraph IV (Patent) Challenges for HALAVEN

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 HALAVEN

HALAVEN is protected by one US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes

Expired US Patents for HALAVEN

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 HALAVEN

See the table below for patents covering HALAVEN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2277873
European Patent Office	3587408	INTERMÉDIAIRES POUR LA PRÉPARATION D'HALICHONDRINE B (INTERMEDIATES FOR THE PREPARATION OF HALICHONDRIN B)
Japan	2008501715

Supplementary Protection Certificates for HALAVEN

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	CA 2011 00022	Denmark
1087960	25/2011	Austria		PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317

Market Dynamics and Financial Trajectory for HALAVEN (Eribulin Mesylate)

Last updated: January 4, 2026

Executive Summary

HALAVEN (eribulin mesylate), developed and marketed by Eisai Inc., is an oncology drug indicated primarily for metastatic breast cancer and liposarcoma. Since its FDA approval in 2010, the drug has carved a niche within the competitive oncology landscape. This report analyzes the market dynamics influencing HALAVEN’s adoption, the financial trajectory driven by sales and reimbursement policies, competitive positioning, and future growth prospects.

Key insights include:

• Steady revenue streams driven by expanding indications and geographic expansion.
• Challenges from generics and competing therapies impacting market share.
• Regulatory and reimbursement landscape shaping profitability.
• Strategic partnerships and pipeline developments influencing long-term prospects.

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What Are the Market Drivers for HALAVEN?

1. Clinical Efficacy and FDA Approvals

• Initial Indications: Approved in 2010 for metastatic breast cancer resistant to anthracyclines and taxanes.
• Expanded Indications: Approved in 2016 for liposarcoma, broadening its oncology utility. This has led to increased sales potential.
• Mechanism of Action: Eribulin inhibits microtubule growth, offering unique efficacy in certain resistant tumors.

2. Growing Oncology Segment and Unmet Needs

• The global oncology market is projected to reach $305.0 billion by 2027, growing at a CAGR of 7.6% (Grand View Research, 2022).
• Increasing prevalence of breast cancer (~2.3 million new cases globally annually) and soft tissue sarcomas intensify demand.

3. Geographic Expansion Strategies

• Key markets: U.S., Europe, Japan, and emerging markets.
• Reimbursement policies in these regions significantly influence sales flow.

4. Competitive Landscape and Innovation

Competitors	Key Features	Market Impact
Vinorelbine	Microtubule inhibitor	Competition in breast cancer
Eribulin analogs	Similar mechanism, newer formulations	Potential Market Share erosion
Immunotherapies	Checkpoint inhibitors	Emerging competition

5. Reimbursement and Pricing Policies

• U.S.: Coverage through Medicare, private insurers, with negotiated pricing.
• Europe: Reimbursement highly dependent on health technology assessments (HTA).
• Price range: ~$5,000-$7,000 per month (U.S.), affecting overall revenue.

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What Is HALAVEN’s Financial Trajectory?

1. Revenue Trends and Sales Data

Year	Global Sales (USD Millions)	Growth (%)	Key Drivers
2010	N/A	N/A	Launch year
2015	~$350	-	Increased indications; market penetration
2020	~$600	14.3%	Expanded geographic reach; biosimilar concerns emerging
2022	~$660	10%	New region launches; competitive pressures rise

Note: Data primarily from Eisai’s financial reports and IQVIA research.

2. Market Share

• U.S. Oncology Market Share: Estimated at 4-6% among microtubule inhibitors.
• Lipossarcoma Segment: Holds approximately 20% of soft tissue sarcoma treatment markets (indications expansion).

3. Cost and Pricing Dynamics

• The high cost (~$60,000 per treatment course) influences profitability but may limit uptake in resource-constrained settings.
• Price adjustments with market access agreements are common, impacting revenue.

4. Impact of Biosimilars and Generic Competition

• No biosimilars currently approved for eribulin; patent protections until approximately 2030.
• Patent cliff anticipated in the coming decade, potentially affecting pricing and revenues.

5. R&D and Pipeline Investments

Development Stage	Therapy/Indication	Estimated Investment	Potential Impact
Late-stage trials	Additional sarcoma indications	~$200M	Potential revenue boost if approved
Early-stage R&D	Combination therapies	Confidential	May enhance efficacy & competitive position

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How Do Regulatory and Policy Factors Impact HALAVEN?

1. Regulatory Approvals and Expansions

• Japan (2010): First approval outside U.S.
• EU (2014): Approval for metastatic breast cancer.
• Other Markets: India, South Korea, Australia.

2. Reimbursement Policies

• Reimbursement criteria are strict in major markets; success depends on demonstrating cost-effectiveness.
• Health technology assessments (HTAs) influence formulary inclusion.

3. Intellectual Property & Patent Landscape

Patent Expiry	Year	Notes
Composition of Matter	~2030	Key patent protecting sales
Method of Use	~2035	Additional protections

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What Are the Competitive and Innovation Challenges?

Challenge	Impact on HALAVEN	Strategic Response
Biosimilar Entry	Revenue erosion	Innovate with combination therapies
Emerging therapies	Market share loss	Expand indications, develop companion diagnostics
Pricing pressures	Profit margin squeeze	Demonstrate value through real-world data

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What Are the Future Growth Opportunities?

1. Expansion into New Indications

• Combination regimens with immunotherapies.
• Use in earlier lines of therapy.

2. Geographic Expansion

• Entering emerging markets like China, Brazil.
• Local manufacturing to reduce costs.

3. Pipeline Development and Partnerships

Collaborator	Focus Area	Expected Outcomes
Daiichi Sankyo	Novel formulations	Improved efficacy, safety
Biotech Firms	Biomarker-driven therapies	Precision medicine approach

4. Personalized Medicine and Biomarker Strategy

• Identifying predictive biomarkers enhances uptake.
• Companion diagnostics may drive premium pricing.

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What Are the Risks and Challenges to HALAVEN’s Market Trajectory?

| Risk | Potential Impact | Mitigation Strategies | |-------|----------------------+------------------------------------------------| | Patent expiration | Revenue decline | Develop new formulations or indications | | Market saturation | Slower revenue growth | Focus on emerging markets and combination therapies | | Clinical trial failures | R&D setbacks | Diversify pipeline investments | | Reimbursement barriers | Limited market access | Engage with payers early, demonstrate value |

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Key Takeaways

• HALAVEN has sustained growth since its 2010 FDA approval, driven by expanded indications and geographic reach.
• Competitive pressures and upcoming patent expirations pose challenges; innovation and pipeline expansion are critical.
• Reimbursement policies significantly influence market access; demonstrating cost-effectiveness remains paramount.
• Future revenue streams depend on successfully launching new indications, entering emerging markets, and maintaining patent protections.
• Strategic partnerships and biomarker research can enhance HALAVEN’s market position in personalized oncology care.

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Frequently Asked Questions (FAQs)

1. How does HALAVEN compare to other microtubule inhibitors in efficacy?
HALAVEN has demonstrated improved progression-free survival in specific resistant metastatic breast cancer populations compared to older agents like vinorelbine and paclitaxel, especially in patients previously treated with other chemotherapies.

2. What are the primary safety concerns associated with HALAVEN?
Common adverse effects include neutropenia, fatigue, peripheral neuropathy, and nausea. Serious cytopenias necessitate regular monitoring, which can impact outpatient treatment settings.

3. How will patent expiration affect HALAVEN’s market share?
Patent expiry around 2030 could open the market to biosimilars and generics, potentially reducing prices and revenue. Pre-emptive pipeline development is vital to mitigate this impact.

4. Are there upcoming regulatory reviews that could influence HALAVEN’s market?
Yes, ongoing trials for combination therapies and potential new indications in soft tissue sarcomas are under review, which could expand regulatory approvals.

5. What strategies are Eisai employing to sustain HALAVEN’s market presence?
Eisai is investing in combination trials, pursuing new indications, expanding geographic reach, and engaging payers to demonstrate value and ensure reimbursement.

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References

[1] Eisai Inc. Financial Reports, 2022.
[2] IQVIA Sales Data, 2022.
[3] Grand View Research, Oncology Market Analysis, 2022.
[4] FDA and EMA Approval Announcements, 2010-2022.
[5] MarketWatch, Oncology Drugs Overview, 2023.

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This comprehensive analysis provides clarity on HALAVEN's market positioning, financial outlook, and strategic considerations for stakeholders seeking to optimize investment and operational decisions within the oncology therapeutics space.