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Last Updated: February 14, 2025

EISAI INC Company Profile


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Summary for EISAI INC
International Patents:327
US Patents:15
Tradenames:8
Ingredients:7
NDAs:11
Drug Master File Entries: 1

Drugs and US Patents for EISAI INC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-001 Feb 13, 2015 RX Yes No ⤷  Try for Free ⤷  Try for Free
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-002 Feb 13, 2015 RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-002 Feb 13, 2015 RX Yes Yes 7,253,286*PED ⤷  Try for Free Y ⤷  Try for Free
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-002 Feb 13, 2015 RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 Nov 14, 2008 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for EISAI INC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 Nov 14, 2008 6,740,669*PED ⤷  Try for Free
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 6,245,911 ⤷  Try for Free
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004 7,727,552 ⤷  Try for Free
Eisai Inc BANZEL rufinamide SUSPENSION;ORAL 201367-001 Mar 3, 2011 7,750,028*PED ⤷  Try for Free
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004 4,895,841 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for EISAI INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 23 mg ➤ Subscribe 2013-07-09
➤ Subscribe Oral Suspension 40 mg/mL ➤ Subscribe 2014-06-16
➤ Subscribe Capsules 4 mg and 10 mg ➤ Subscribe 2019-02-13
➤ Subscribe Tablets 100 mg, 200 mg and 400 mg ➤ Subscribe 2012-11-14
➤ Subscribe Orally Disintegrating Tablets 5 mg and 10 mg ➤ Subscribe 2010-06-30

Supplementary Protection Certificates for EISAI INC Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296560 2/1998 Austria ⤷  Try for Free PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
1415987 553 Finland ⤷  Try for Free
1698623 PA2015039,C1698623 Lithuania ⤷  Try for Free PRODUCT NAME: LENVATINIBAS; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528
1698623 C 2015 041 Romania ⤷  Try for Free PRODUCT NAME: LENVATINIB; NATIONAL AUTHORISATION NUMBER: DATA NOTIFICARII 01.06.2015 EU/1/15/001, EU/1/15/002; DATE OF NATIONAL AUTHORISATION: 20150528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DATA NOTIFICARII 01.06.2015 EU/1/15/001, EU/1/15/002; DATE OF FIRST AUTHORISATION IN EEA: 20150528
1087960 SPC/GB11/039 United Kingdom ⤷  Try for Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

EISAI INC Market Analysis and Financial Projection

Pharmaceutical Competitive Landscape Analysis: Eisai Inc – Market Position, Strengths & Strategic Insights

Eisai Inc., a subsidiary of the Japanese pharmaceutical giant Eisai Co., Ltd., has established itself as a formidable player in the global pharmaceutical industry. With a rich history spanning over 80 years and a strong focus on research and development, Eisai has carved out a significant market position, particularly in the areas of neurology and oncology. This comprehensive analysis delves into Eisai's competitive landscape, examining its market position, strengths, and strategic insights that drive its success in the pharmaceutical sector.

Eisai's Global Presence and Market Position

Eisai has successfully expanded its global footprint, operating in more than 40 countries worldwide[1]. The company's strategic focus on key therapeutic areas has allowed it to establish a strong market presence, particularly in developed markets like the United States, Europe, and Japan.

Revenue and Market Share

As of fiscal year 2023, Eisai reported an annual revenue of 741.8 billion yen (approximately $6.7 billion USD)[1]. While this places Eisai outside the top 10 global pharmaceutical companies by revenue, it solidifies its position as a mid-sized player with significant market influence in its core therapeutic areas.

Geographic Distribution

Eisai's revenue is well-distributed across major pharmaceutical markets:

  • Japan: Approximately 40% of total revenue
  • Americas (primarily U.S.): Around 30%
  • Europe: Roughly 15%
  • Asia and other regions: About 15%

This geographic diversification helps Eisai mitigate risks associated with market-specific challenges and capitalize on growth opportunities across different regions.

Core Therapeutic Areas and Key Products

Eisai's competitive strategy revolves around focusing on specific therapeutic areas where it can leverage its expertise and innovation capabilities.

Neurology

Neurology represents one of Eisai's strongest areas, with a particular emphasis on Alzheimer's disease and epilepsy.

Alzheimer's Disease

Eisai's flagship product in this space is Leqembi (lecanemab), developed in collaboration with Biogen. Leqembi received accelerated approval from the FDA in January 2023 for the treatment of Alzheimer's disease[2]. This breakthrough therapy positions Eisai at the forefront of Alzheimer's treatment, a market with significant growth potential due to the aging global population.

Epilepsy

Eisai's epilepsy portfolio includes established products like:

  • Fycompa (perampanel)
  • Inovelon/Banzel (rufinamide)
  • Zonegran (zonisamide)

These medications contribute significantly to Eisai's neurology revenue and market share in the epilepsy segment.

Oncology

In the oncology field, Eisai has made substantial strides with key products such as:

  • Lenvima (lenvatinib): A kinase inhibitor approved for various cancer types, including thyroid, renal cell, and hepatocellular carcinoma.
  • Halaven (eribulin): Used in the treatment of metastatic breast cancer and liposarcoma.

These oncology drugs have shown strong growth potential and contribute significantly to Eisai's revenue stream.

Research and Development Capabilities

Eisai's commitment to innovation is evident in its robust R&D infrastructure and investment.

R&D Expenditure

Eisai consistently invests a significant portion of its revenue in R&D activities. In fiscal year 2023, the company's R&D expenses amounted to approximately 17% of its total revenue[1]. This level of investment underscores Eisai's commitment to developing innovative therapies and maintaining its competitive edge.

Research Facilities

Eisai operates 14 drug discovery, research and development, and clinical research sites globally[1]. These facilities enable the company to tap into diverse talent pools and collaborate with leading academic institutions and biotech companies worldwide.

Pipeline Strength

Eisai's pipeline includes 42 R&D projects in scope, with 15 targeting priority diseases and 27 focusing on other diseases[3]. This diverse pipeline demonstrates Eisai's commitment to addressing unmet medical needs across various therapeutic areas.

"Eisai has 42 R&D projects in scope, 15 of which target priority diseases, including malaria (8), Chagas disease (3) and leishmaniasis (2). The remaining 27 projects target other diseases in scope, including cancer (21), Alzheimer's disease (5) and epilepsy (1)."[3]

Strategic Partnerships and Collaborations

Eisai has strategically leveraged partnerships to enhance its research capabilities and market reach.

Biogen Collaboration

The partnership with Biogen for the development and commercialization of Leqembi has been particularly significant. This collaboration combines Eisai's expertise in neurology with Biogen's global reach and commercial capabilities.

Academic and Research Institutions

Eisai actively collaborates with universities and research institutions to accelerate drug discovery. For instance, the company has an IP-sharing agreement with Universidad Nacional de La Plata to accelerate drug discovery for Chagas disease[3].

Manufacturing and Supply Chain Capabilities

Eisai's manufacturing network plays a crucial role in maintaining its competitive position.

Global Production Sites

The company operates 9 production sites globally[1], ensuring a robust and flexible supply chain capable of meeting market demands across different regions.

Supply Chain Management

Eisai has implemented strategies to ensure continuous supply in low- and middle-income countries (LMICs). For example, the company manufactures diethylcarbamazine citrate (DEC) tablets at its own site in India to supply lymphatic filariasis elimination programs in several countries[3].

Market Access and Pricing Strategies

Eisai's approach to market access and pricing reflects its commitment to balancing commercial success with global health needs.

Differential Pricing

The company implements differential pricing strategies for some of its products in LMICs, aiming to improve access to essential medicines in these markets.

Access Planning

While Eisai has a structured framework for access planning, there is room for improvement. Currently, only 6% (1/18) of its late-stage R&D projects have comprehensive access plans in place[3].

Corporate Social Responsibility and Global Health Initiatives

Eisai's commitment to corporate social responsibility (CSR) and global health initiatives enhances its reputation and market position.

Neglected Tropical Diseases

The company is actively involved in efforts to eliminate lymphatic filariasis, providing free DEC tablets to the WHO for mass drug administration programs[3].

Health System Strengthening

Eisai engages in health system strengthening initiatives, such as supporting mass drug administration programs and raising awareness about hygiene practices in countries like Myanmar[3].

Competitive Challenges and Market Threats

Despite its strengths, Eisai faces several challenges in the highly competitive pharmaceutical landscape.

Intense Competition

In key therapeutic areas like Alzheimer's disease and oncology, Eisai faces stiff competition from both large pharmaceutical companies and innovative biotech firms.

Patent Expirations

Like all pharmaceutical companies, Eisai must navigate the challenges posed by patent expirations on key products, which can lead to revenue declines due to generic competition.

Regulatory Hurdles

The increasingly complex regulatory environment, particularly for novel therapies like Leqembi, presents ongoing challenges for market access and commercialization.

Future Outlook and Strategic Directions

Looking ahead, Eisai's competitive position will likely be shaped by several key factors:

Focus on Neurology and Oncology

Continued investment and innovation in these core therapeutic areas will be crucial for maintaining and expanding market share.

Expansion in Emerging Markets

Eisai has opportunities to further expand its presence in high-growth emerging markets, particularly in Asia and Latin America.

Digital Health and AI Integration

Leveraging digital health technologies and artificial intelligence in drug discovery and development could provide a competitive edge.

Sustainability and Access Initiatives

Strengthening its commitment to global health and access initiatives could enhance Eisai's reputation and open new market opportunities.

Key Takeaways

  • Eisai Inc. has established a strong market position in neurology and oncology, with flagship products like Leqembi and Lenvima driving growth.
  • The company's robust R&D investment and global research network position it well for future innovation.
  • Strategic partnerships, particularly with Biogen for Leqembi, have enhanced Eisai's market reach and development capabilities.
  • While facing competitive challenges, Eisai's focused therapeutic approach and commitment to innovation provide a solid foundation for future growth.
  • Opportunities exist for expanding access initiatives and leveraging digital technologies to maintain competitiveness in the evolving pharmaceutical landscape.

FAQs

  1. What are Eisai's main therapeutic focus areas? Eisai primarily focuses on neurology (particularly Alzheimer's disease and epilepsy) and oncology.

  2. How does Eisai's R&D investment compare to industry standards? Eisai invests approximately 17% of its revenue in R&D, which is relatively high compared to the industry average of around 15-20%.

  3. What is Eisai's most promising recent product launch? Leqembi (lecanemab), approved for Alzheimer's disease treatment, is Eisai's most significant recent product launch with high growth potential.

  4. How is Eisai addressing global health challenges? Eisai contributes to global health through initiatives like providing free DEC tablets for lymphatic filariasis elimination and engaging in health system strengthening activities in developing countries.

  5. What are the main challenges Eisai faces in maintaining its competitive position? Key challenges include intense competition in core therapeutic areas, patent expirations, regulatory hurdles, and the need to expand access initiatives in emerging markets.

Sources cited: [1] https://www.eisai.com/company/glance/index.html [2] https://www.pharmaceutical-technology.com/news/eisai-lowers-leqembi-revenue-forecast-after-rocky-entry-to-market/ [3] https://accesstomedicinefoundation.org/company/eisai-co-ltd

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