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. Seven 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 PHARMA LTD 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:	31
Clinical Trials:	63
Patent Applications:	7
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
Australia	2005250487	Intermediates for the preparation of halichondrin B
Hungary	P0103357	Halichondrinanalógok és eljárás előállításukra és alkalmazásukra (HALICHONDRIN ANALOGS AND METHODS OF THEIR USE AND PREPARATION)
Israel	247620	הרכב ושיטה ליצירתו עבור הכנת הליקונדרין b (Compound and method of synthesizing same for the preparation of halichondrin b)
Japan	2008501715
Norway	2022019
World Intellectual Property Organization (WIPO)	2007061874

Supplementary Protection Certificates for HALAVEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1087960	132011901976051	Italy		PRODUCT NAME: ERIBULINA(HALAVEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/678/001-002, 20110317
1087960	2011C/028	Belgium		PRODUCT NAME: ERIBULIN; AUTHORISATION NUMBER AND DATE: EU/1/11/678/001 20110317
1087960	394	Finland
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

Market Dynamics and Financial Trajectory for HALAVEN (eribulin mesylate)

Introduction to HALAVEN

HALAVEN, or eribulin mesylate, is a groundbreaking anticancer agent discovered and developed by Eisai Co., Ltd. It is primarily used to treat adults with metastatic breast cancer and certain types of soft-tissue sarcoma. Here, we delve into the market dynamics and financial trajectory of this significant pharmaceutical product.

Discovery and Development

The journey of HALAVEN began in the 1990s with the discovery of halichondrin B, a substance derived from the black sea sponge found off the coast of Japan. This natural compound exhibited potent anticancer activity. Through a collaborative effort involving the National Cancer Institute (NCI), Harvard University, and Eisai, the drug was synthesized, optimized, and brought to market[3].

Regulatory Approvals

HALAVEN received its first FDA approval in November 2010 for the treatment of patients with metastatic breast cancer who had previously received at least two chemotherapeutic regimens. This was followed by approvals in numerous countries, including those in the European Union, Japan, and Australia. By 2013, it was approved in more than 50 countries worldwide[1][4].

In January 2016, the FDA approved HALAVEN for the treatment of inoperable liposarcoma in patients who had received prior chemotherapy containing an anthracycline drug[3].

Market Expansion

Eisai's strategic expansion plans, outlined in its mid-term strategic plan "HAYABUSA," aimed to establish the company as one of the top 20 largest pharmaceutical companies globally by fiscal 2015. The launch of HALAVEN in key markets was a crucial part of this strategy.

• Australia: HALAVEN was approved in Australia in 2012, marking a significant entry into the Australian market, which is the 13th largest pharmaceutical market globally[1].
• Russia: In 2013, HALAVEN was launched in Russia, making it the first product marketed by Eisai in this country. Russia's pharmaceutical market is one of the fastest-growing, ranking 11th globally[4].

Clinical Trials and Efficacy

The efficacy of HALAVEN was demonstrated in several clinical trials, most notably the EMBRACE study. This Phase III trial showed that HALAVEN extended overall survival by 2.5 months compared to treatment of physician's choice (TPC) in patients with advanced or recurrent breast cancer previously treated with an anthracycline and a taxane[4].

Key Statistics from Clinical Trials

• Overall Survival: HALAVEN indicated an extended overall survival of 2.5 months (OS of 13.1 months versus 10.6 months, respectively; Hazard Ratio (HR) 0.81; p=0.041) compared to TPC[4].
• Adverse Reactions: Common adverse reactions included neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation. Serious adverse reactions were primarily neutropenia with or without fever[2][4].

Financial Assistance and Patient Access

To enhance patient access, Eisai has implemented several financial assistance programs.

• HALAVEN $0 Co-Pay Program: Eligible commercially insured patients can pay as little as $0 per month, with Eisai covering up to $18,000 per year in out-of-pocket costs[5].

Market Impact and Revenue

The approval and subsequent launches of HALAVEN in various markets have significantly contributed to Eisai's revenue.

• Global Reach: With approvals in over 50 countries, HALAVEN has become a key product in Eisai's portfolio, contributing to the company's global revenue growth.
• Market Size: The metastatic breast cancer market, in particular, is substantial. In Australia, for example, breast cancer affects an estimated 150,000 people, with approximately 15,000 new cases diagnosed each year[1].

Future Development and Expansion

Eisai continues to explore additional indications for HALAVEN, including its potential use in treating soft-tissue sarcoma and non-small cell lung cancer. The company is also working on a liposome formulation to enhance the drug's delivery to target cancer cells[1][4].

Ongoing Clinical Trials

• Breast Cancer with Fewer Prior Treatments: Eisai has filed an application with the European Medicines Agency (EMA) for HALAVEN as a therapy in the treatment of breast cancer with fewer prior treatments[4].
• Other Cancers: Clinical trials are ongoing to investigate the efficacy of HALAVEN in other types of cancer, further expanding its potential market[1].

Key Takeaways

• Regulatory Approvals: HALAVEN has received approvals in over 50 countries, including the U.S., EU, Japan, and Australia.
• Clinical Efficacy: The drug has demonstrated significant overall survival benefits in clinical trials, particularly in the EMBRACE study.
• Market Expansion: Strategic launches in key markets like Australia and Russia have been crucial for its global reach.
• Financial Assistance: Patient access programs, such as the $0 Co-Pay Program, have been implemented to reduce financial burdens on patients.
• Future Development: Ongoing clinical trials aim to expand HALAVEN's indications and improve its delivery mechanism.

FAQs

Q1: What is HALAVEN used to treat?

HALAVEN (eribulin mesylate) is used to treat adults with metastatic breast cancer who have previously received at least two chemotherapeutic regimens and certain types of soft-tissue sarcoma.

Q2: When was HALAVEN first approved by the FDA?

HALAVEN was first approved by the FDA in November 2010 for the treatment of metastatic breast cancer.

Q3: What are the common adverse reactions associated with HALAVEN?

Common adverse reactions include neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation.

Q4: How does the HALAVEN $0 Co-Pay Program work?

The HALAVEN $0 Co-Pay Program allows eligible commercially insured patients to pay as little as $0 per month, with Eisai covering up to $18,000 per year in out-of-pocket costs.

Q5: What are the ongoing clinical trials for HALAVEN?

Ongoing clinical trials are investigating the use of HALAVEN in treating breast cancer with fewer prior treatments, soft-tissue sarcoma, and non-small cell lung cancer, as well as developing a liposome formulation for improved drug delivery.

Sources

1. Eisai Co., Ltd. - EISAI RECEIVES APPROVAL TO MARKET ANTICANCER AGENT HALAVEN® (eribulin mesylate) IN AUSTRALIA.
2. Eisai - Financial Program & Patient Assistance for HALAVEN® (eribulin mesylate).
3. NCI Technology Transfer Center - Halaven - An NIH Success Story.
4. Eisai Co., Ltd. - EISAI ANNOUNCES LAUNCH OF ANTICANCER AGENT HALAVEN® (eribulin mesylate) IN RUSSIA.
5. Eisai Patient Support - Financial Assistance for Patients | HALAVEN (eribulin mesylate).