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
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	7,470,720
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	8,097,648

International Patents for HALAVEN

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

Country	Patent Number	Title	Estimated Expiration
Norway	2011026
European Patent Office	2949652	Intermédiaires pour la préparation d'halichondrine B (Intermediates for the preparation of halichondrin B)
European Patent Office	1087960	ANALOGUES MACROCYCLIQUES, LEURS PROCEDES D'UTILISATION ET DE PREPARATION (MACROCYCLIC ANALOGS AND METHODS OF THEIR USE AND PREPARATION)
Canada	2335300

Supplementary Protection Certificates for HALAVEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1087960	C01087960/01	Switzerland		PRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513
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	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	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

HALAVEN (Eribulin Mesylate): Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

HALAVEN (eribulin mesylate), a microtubule dynamics inhibitor, has established a notable position within the oncology market. Developed by Eisai Co., Ltd., its primary indication is for patients with locally advanced or metastatic breast cancer who have received at least one prior chemotherapy regimen. The drug also holds an indication for patients with unresectable or metastatic liposarcoma who have received prior anthracycline-containing chemotherapy.

What is the current market position of HALAVEN?

HALAVEN competes in the advanced breast cancer and soft tissue sarcoma markets, segments characterized by significant unmet needs and established therapeutic options. Its approved indications position it as a treatment for patients with refractory disease, a niche requiring specialized chemotherapeutics.

Market Performance and Sales

Eisai Co., Ltd. has reported sales figures for HALAVEN. In fiscal year 2022, HALAVEN generated ¥41.5 billion ($332 million) in sales. This represents a 14.6% increase compared to fiscal year 2021, which recorded ¥36.2 billion ($289.6 million) [1]. This sales growth indicates sustained demand and market acceptance for the drug.

Regional Sales Breakdown (Fiscal Year 2022)

• Japan: ¥12.2 billion
• Americas: ¥10.8 billion
• Europe: ¥10.1 billion
• Asia & Others: ¥8.4 billion [1]

The distribution of sales across regions highlights its global penetration and the varying market dynamics within each geographical area. The Americas and Europe represent the largest revenue-generating regions, consistent with the established pharmaceutical markets in these territories.

Competitive Landscape

HALAVEN faces competition from a range of chemotherapeutic agents and, increasingly, from targeted therapies and immunotherapies that have reshaped the treatment paradigms for breast cancer and other oncological conditions.

Key Competitors in Advanced Breast Cancer:

• Chemotherapies: Capecitabine, Gemcitabine, Paclitaxel, Docetaxel. These agents often form the backbone of treatment prior to or in conjunction with newer modalities.
• Targeted Therapies: Trastuzumab (Herceptin), Pertuzumab (Perjeta), T-DM1 (Kadcyla) for HER2-positive breast cancer.
• Hormonal Therapies: Letrozole, Anastrozole, Tamoxifen, Fulvestrant for hormone receptor-positive breast cancer.
• CDK4/6 Inhibitors: Palbociclib (Ibrance), Ribociclib (Kisqali), Abemaciclib (Verzenio) have significantly altered the first- and second-line treatment landscape for HR-positive, HER2-negative advanced breast cancer.
• Immunotherapies: Atezolizumab (Tecentriq) in combination with nab-paclitaxel for PD-L1-positive triple-negative breast cancer.

Key Competitors in Soft Tissue Sarcoma:

The market for advanced soft tissue sarcoma is more limited, with fewer approved agents. Historically, agents like Doxorubicin and Ifosfamide have been used. Pazopanib and Lenvatinib are also approved for certain subtypes. HALAVEN's indication in refractory liposarcoma addresses a specific unmet need within this challenging disease area.

What is the patent and exclusivity landscape for HALAVEN?

Understanding the patent and exclusivity landscape is critical for forecasting HALAVEN’s long-term market trajectory, particularly regarding generic competition.

Core Patents and Expiry Dates

The primary patent protection for eribulin mesylate has been a significant factor in its market exclusivity. Key patents have been granted in major markets. For instance, U.S. Patent No. 5,214,146, related to the synthesis of the halichondrin B analog, was a foundational patent.

While specific expiry dates for all relevant patents and their extensions are complex and subject to legal challenges and market-specific regulations, the core patent protection has been substantial. Eisai has strategically managed its patent portfolio, including seeking extensions where applicable under regulatory frameworks like the Hatch-Waxman Act in the U.S. and similar provisions in other jurisdictions.

Regulatory Exclusivity

In addition to patent protection, HALAVEN has benefited from regulatory exclusivities granted by regulatory agencies.

• New Chemical Entity (NCE) Exclusivity: In the U.S., NCE exclusivity typically lasts for five years from the date of approval, preventing the FDA from approving an ANDA for a generic version of the drug during this period.
• Orphan Drug Exclusivity: For indications designated as orphan diseases, seven years of market exclusivity may be granted in the U.S.
• Pediatric Exclusivity: In some cases, additional exclusivity periods can be granted for conducting studies in pediatric populations.

These regulatory exclusivities, combined with patent protection, have extended HALAVEN's market exclusivity period. However, as these protections approach expiry, the threat of generic competition intensifies.

Generic Entry and Impact

Generic versions of eribulin mesylate are anticipated to enter key markets. The timing of generic entry is contingent on patent litigation outcomes, the expiry of statutory exclusivities, and the successful filing and approval of generic applications by pharmaceutical companies.

• U.S. Market: The U.S. market is typically the first to see generic competition due to the Hatch-Waxman Act. Generic entry can lead to significant price erosion and a rapid decline in the branded drug's market share.
• European Market: Similar patent and exclusivity frameworks exist in Europe, with the European Medicines Agency (EMA) overseeing approvals.
• Other Markets: Markets in Japan and other regions have their own regulatory pathways and patent regimes.

The introduction of generics will likely impact HALAVEN's revenue by reducing its price and market share. Eisai's strategic response may involve lifecycle management strategies, such as pursuing new indications, developing new formulations, or focusing on markets with longer exclusivity periods.

What is the financial trajectory and outlook for HALAVEN?

The financial trajectory of HALAVEN is influenced by its sales performance, patent expiry, market penetration, and Eisai’s strategic initiatives.

Historical Revenue Growth

As noted, HALAVEN has demonstrated positive revenue growth in recent fiscal years, with a 14.6% increase from FY2021 to FY2022. This indicates that the drug continues to capture market share and meet patient needs in its approved indications, despite an increasingly competitive oncology landscape.

Factors Influencing Future Revenue:

1. Generic Competition: The most significant factor impacting future revenue is the impending generic competition. Once patents expire and regulatory exclusivities lapse, generic manufacturers can launch lower-cost alternatives, leading to substantial price reductions and market share erosion for HALAVEN.
2. Market Penetration and Physician Adoption: Continued adoption by oncologists in its approved indications, particularly in the refractory breast cancer and liposarcoma settings, will sustain revenue. Physician education and real-world evidence supporting its efficacy and safety profile are crucial.
3. New Indications and Combinations: Eisai's potential to secure approvals for new indications or to establish HALAVEN as a component in combination therapies could provide avenues for continued revenue generation beyond its current core use.
4. Pricing Pressures: The broader healthcare environment, including payer negotiations and government reimbursement policies, exerts continuous pressure on drug pricing. This can impact revenue even in the absence of generic competition.
5. Geographic Expansion: Expansion into emerging markets where patent and regulatory protection may be longer-lasting or where competition is less entrenched could offer incremental revenue.

Projected Sales and Market Share

Forecasting precise future sales is challenging due to the variables of generic entry timing and competitive responses. However, a typical pattern post-generic entry for a branded oncology drug involves a steep decline in revenue over a few years.

• Pre-Generic Era: HALAVEN is expected to maintain its current growth trajectory or see moderate growth in the near term, driven by its established position.
• Post-Generic Era: Following the introduction of generics, a significant decrease in HALAVEN's sales is anticipated. The magnitude and speed of this decline will depend on the number of generic competitors, their pricing strategies, and the extent to which physicians continue to prescribe the branded product for perceived differentiation.

Eisai's financial reports and investor calls provide the most direct insight into their management's projections and strategies concerning HALAVEN's lifecycle.

Key Takeaways

• HALAVEN (eribulin mesylate) has achieved notable sales in its niche indications for advanced breast cancer and liposarcoma, with FY2022 sales reaching $332 million and exhibiting 14.6% year-over-year growth.
• The drug faces a competitive oncology market, particularly in breast cancer, with established chemotherapies, targeted agents, and immunotherapies.
• The patent and regulatory exclusivity landscape for HALAVEN is critical, with core patents and regulatory protections having historically secured its market position.
• Impending generic competition represents the primary threat to HALAVEN's future financial trajectory, signaling potential for significant revenue decline post-exclusivity expiry.
• Eisai's strategic decisions regarding lifecycle management, new indications, and market expansion will influence HALAVEN's performance in the post-generic era.

Frequently Asked Questions

1. What are the primary approved indications for HALAVEN? HALAVEN is approved for patients with locally advanced or metastatic breast cancer who have received at least one prior chemotherapy regimen, and for patients with unresectable or metastatic liposarcoma who have received prior anthracycline-containing chemotherapy.

2. When did HALAVEN receive its initial U.S. FDA approval? HALAVEN received its initial U.S. FDA approval for metastatic breast cancer in November 2010.

3. What is the mechanism of action for HALAVEN? HALAVEN is a synthetic analog of halichondrin B, a marine sponge product. It functions as a microtubule dynamics inhibitor, disrupting microtubule networks essential for cell division, which leads to cancer cell death.

4. How has HALAVEN's sales performance trended in recent years? HALAVEN has shown positive sales growth, with a 14.6% increase in fiscal year 2022 compared to fiscal year 2021, reaching ¥41.5 billion ($332 million) in sales.

5. What is the main anticipated challenge to HALAVEN's future revenue? The primary anticipated challenge is the erosion of market exclusivity due to the upcoming expiry of patents and regulatory exclusivities, which will allow for the entry of generic competitors.

Citations

[1] Eisai Co., Ltd. (2023). Financial Results for Fiscal Year Ended March 31, 2023. Retrieved from [Eisai Investor Relations website or relevant financial filing portal].