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. Fourteen 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
Guangdong Provincial People's Hospital	Phase 2
First Affiliated Hospital, Sun Yat-Sen University	Phase 2
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	RE46965*PED				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	6,469,182
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	8,097,648
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	7,470,720

International Patents for HALAVEN

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2245335	МАКРОЦИКЛИЧЕСКОЕ СОЕДИНЕНИЕ И СПОСОБ ИДЕНТИФИКАЦИИ АГЕНТА НА ЕГО ОСНОВЕ (MACROCYCLIC COMPOUND AND METHOD FOR IDENTIFYING AGENT BASED ON THEREOF)
Japan	6306235
Israel	180252	תרכובות ושיטות להכנת אנלוג של@הליקונדרין@b (Compounds and methods for the preparation of an analog of halichondrin b)
Japan	5964926

Supplementary Protection Certificates for HALAVEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1087960	11C0038	France		PRODUCT NAME: ERIBULINE, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER MESYLATE D'ERIBULINE; REGISTRATION NO/DATE: EU/1/11/678/001 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	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	CA 2011 00022	Denmark

Market Dynamics and Financial Trajectory for HALAVEN

Last updated: July 27, 2025

Introduction

HALAVEN (eribulin mesylate) stands as a significant player within the niche of oncology therapeutics, primarily authorized for metastatic breast cancer and liposarcoma indications. Since its initial approval by the U.S. Food and Drug Administration (FDA) in 2010, HALAVEN has exemplified a complex interplay of market forces—regulatory pathways, competitive landscape, patent protections, and clinical efficacy—that shape its financial trajectory. This analysis delves into the core market dynamics influencing HALAVEN's position and projects its financial outlook based on current trends and strategic developments.

Regulatory Environment and Approval Landscape

The regulatory pathway significantly impacts HALAVEN's market penetration, pricing potential, and lifecycle. ALBER (Eisai Inc.), the marketing licensee, secured approvals in multiple jurisdictions, including FDA approval for metastatic breast cancer (2010), and later for liposarcoma (2016). Beyond the U.S., approvals in the European Union, Japan, and other markets facilitate a broader revenue base. However, regulatory hurdles remain, especially concerning indications expansion or line-of-therapy changes, which require robust clinical data.

The recent emphasis on accelerated approval pathways and breakthrough therapy designations offers opportunities for expedited market access. HALAVEN's designation as a treatment with substantial clinical benefit underlines its strategic positioning, although delayed or failed approvals in certain markets can dampen revenue expectations.

Market Size and Patient Demographics

The oncology therapeutics landscape is driven by an aging global population and increasing cancer incidence rates. Specifically:

• Metastatic Breast Cancer: The global incidence exceeds 1.9 million annually, with a substantial subset receiving line-of-therapy options such as HALAVEN, especially in later-line settings where treatment options are limited.

• Lipossarcoma: Although a rarer indication, the 5-year survival rate for liposarcoma remains low, and HALAVEN offers an important therapeutic alternative after anthracycline-based regimens.

Market research estimates suggest that the total addressable market for HALAVEN in these indications exceeds $1-1.5 billion annually, impacted by factors such as line-of-therapy, treatment resistance, and compliance. The increasing adoption in developed markets and emerging markets further broadens this scope.

Competitive Landscape

HALAVEN operates within a highly competitive anti-cancer milieu, competing with agents such as:

• Taxanes and Anthracyclines: Established frontline treatments, though often rendered ineffective against resistant tumors.
• Other Microtubule Inhibitors: Including vinorelbine and eribulin analogs.
• Emerging Targeted Therapies and Immunotherapies: Such as PARP inhibitors, checkpoint inhibitors, and antibody-drug conjugates.

The clinical positioning of HALAVEN in later-line therapy, especially post-approval for metastatic breast cancer following other chemotherapies, offers a niche but also constrains growth if competing agents demonstrate superior efficacy or safety.

Patent Life and Generic Competition

Patent protections are critical in sustaining HALAVEN's premium pricing. Eisai’s patent portfolio for eribulin mesylate shields the drug until approximately 2030. The expiration of key patents could introduce generic competitors, exerting downward pressure on pricing and margins.

However, the complex synthesis of HALAVEN and its proprietary formulation could delay generic entry, extending market exclusivity. Additionally, data exclusivity and orphan drug designations in certain jurisdictions further defend sales.

Pricing Strategies and Reimbursement

Pricing strategies for HALAVEN are influenced by clinical benefit, treatment cost offsets, and payer negotiations. Being an expensive oncology drug, its reimbursement status is pivotal. Willingness of healthcare systems to pay for late-line therapies depends on demonstrated survival benefits, quality-of-life improvements, and cost-effectiveness analyses.

Eisai’s interactions with payers to justify premium pricing, coupled with value-based care models, influence the drug’s revenue trajectory. Moreover, in markets with high unmet medical needs, reimbursement barriers are relatively lower.

Current and Projected Financial Performance

Eisai's published financials indicate steady revenue from HALAVEN, with recent estimates placing annual sales around $300-400 million globally[1]. Growth momentum tapers in mature markets with inevitable patent cliffs; however, expansion into new indications and markets sustains its income.

• 2020–2022 Trends: Slight growth driven by expanded indications and geographic expansion.
• 2023–2025 Forecast: Moderate growth expected, contingent upon successful indication expansions, such as in combination therapies or adjuvant settings. Pricing pressures and patent expiration risk temper optimistic projections.

Eisai’s strategic focus on clinical development, including combination trials with immunotherapies, aims to boost HALAVEN’s utility and revenue.

Clinical Pipeline and Future Outlook

Investment in research aims to extend HALAVEN’s lifecycle through:

• Combination Regimens: Trials exploring co-administration with immune checkpoint inhibitors (e.g., pembrolizumab) aim to broaden efficacy profiles.

• New Indications: Orphan or niche markets, such as other soft tissue sarcomas, offer expansion possibilities.

• Biomarker-driven Approvals: Personalized medicine approaches could position HALAVEN in targeted subsets, potentially commanding premium prices.

Successful clinical data and regulatory approvals of these strategies could significantly alter HALAVEN’s financial journey, extending its commercial relevancy into the late 2020s and early 2030s.

Market Risks and Challenges

Several risks threaten HALAVEN's financial trajectory:

• Patent Expiry and Generics: Erode revenue streams; generic entry could rapidly diminish margins.
• Clinical and Regulatory Failures: New trial setbacks could limit indication expansion.
• Pricing and Reimbursement pressures: Cost-containment policies, especially in Europe and emerging markets, impact profitability.
• Competitive Innovation: Emergence of superior or more convenient therapies could limit use.

Strategic Recommendations

To optimize HALAVEN’s market position, stakeholders should consider:

• Accelerating combination therapy trials to enhance efficacy.
• Expanding indications into earlier lines of therapy where approval pathways are favorable.
• Engaging with payers early to establish value-based reimbursement models.
• Investing in lifecycle management to extend patent protections.

Key Takeaways

• HALAVEN remains a valuable asset in niche oncology indications, with a current global sales estimate of $300-400 million.
• Market growth prospects hinge upon indication expansion, combination regimens, and geographic penetration.
• Patent protections until 2030 provide a window for revenue maximization but require proactive lifecycle strategies.
• Competition from generics, reimbursement pressures, and emerging therapies pose significant risks.
• Strategic clinical development and stakeholder engagement are critical to prolong HALAVEN's market relevance and financial viability.

Frequently Asked Questions

1. How does HALAVEN’s patent status affect its market exclusivity?
HALAVEN’s patents, protected until approximately 2030, safeguard it from generic competition. Once these patents expire, generic eribulin formulations could enter the market, potentially disrupting sales and driving down prices.

2. What are the primary indications driving HALAVEN’s revenue?
Metastatic breast cancer (particularly post- prior chemotherapy) and liposarcoma are the main revenue contributors, with ongoing trials seeking expanded indications.

3. How does the competitive landscape impact HALAVEN’s prospects?
While HALAVEN occupies a niche role, emerging targeted therapies and immunotherapies, along with potential generics, could threaten its market share, especially in later-line settings.

4. What strategic moves could extend HALAVEN’s commercial life?
Indication expansion, combination therapy trials, pipeline diversification, and engagement with payers to demonstrate value are key strategies.

5. What are the key risks to HALAVEN’s future revenues?
Patent expiration, clinical trial failures, regulatory hurdles, pricing pressures, and fierce competition from novel therapies threaten future financial performance.

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References

[1] Eisai Inc. 2022 Annual Report.
[2] FDA approvals and labels.
[3] Market research estimates on oncology therapeutics.
[4] Patent and lifecycle management literature.