Otsuka Company Profile

What is the competitive landscape for OTSUKA

OTSUKA has seventeen approved drugs.

There are fifty-four US patents protecting OTSUKA drugs.

There are one thousand and eleven patent family members on OTSUKA drugs in fifty-four countries and forty-two supplementary protection certificates in sixteen countries.

Summary for Otsuka

International Patents:	1011
US Patents:	54
Tradenames:	15
Ingredients:	10
NDAs:	17
Patent Litigation for Otsuka:	See patent lawsuits for Otsuka

Drugs and US Patents for Otsuka

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-004	Jun 7, 2006		DISCN	Yes	No
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-004	Nov 15, 2002	AB	RX	Yes	No	9,125,939
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		DISCN	Yes	No	9,268,909		Y
Otsuka	PLETAL	cilostazol	TABLET;ORAL	020863-001	Jan 15, 1999		DISCN	Yes	No

Expired US Patents for Otsuka

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-002	Jun 7, 2006	8,017,615*PED
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-004	Nov 15, 2002	4,734,416
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014	8,993,761
Otsuka America	MERETEK UBT KIT (W/ PRANACTIN)	urea c-13	FOR SOLUTION;ORAL	020586-001	Sep 17, 1996	4,830,010

Paragraph IV (Patent) Challenges for OTSUKA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Oral Solution	1 mg/mL		2007-12-20
	Orally Disintegrating Tablets	10 mg, 15 mg, 20 mg and 30 mg		2006-11-15
	Tablets	60 mg		2018-03-26
	Tablets	2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg		2006-11-15
	Tablets	15 mg and 30 mg		2013-09-23
	Injection	6 mg/mL		2012-12-26

International Patents for Otsuka Drugs

Country	Patent Number	Estimated Expiration
Denmark	2774595
Serbia	51903
South Korea	20130020744
South Korea	20140075754

Supplementary Protection Certificates for Otsuka Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	122023000069	Germany		PRODUCT NAME: ZUSAMMENSETZUNG UMFASSEND: CEDAZURIDIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; UND DECITABIN; REGISTRATION NO/DATE: EU/1/23/1756 20230915
2207786	301256	Netherlands		PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918
1869025	C201830050	Spain		PRODUCT NAME: BREXPIPRAZOL O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1294; DATE OF AUTHORISATION: 20180726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1294; DATE OF FIRST AUTHORISATION IN EEA: 20180726
0367141	SPC/GB04/039	United Kingdom		PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Otsuka
• Otsuka America
• Otsuka Pharm
• Otsuka Pharm Co Ltd

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

In the ever-evolving pharmaceutical industry, Otsuka Holdings Co., Ltd. stands out as a global healthcare company with a unique approach to addressing unmet medical needs. This comprehensive analysis delves into Otsuka's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Company Overview

Otsuka Pharmaceutical Co., Ltd., a subsidiary of Otsuka Holdings, was established on August 10, 1964, in Tokyo, Japan[1]. With a global presence spanning 28 countries and over 180 companies under its umbrella, Otsuka has positioned itself as a significant player in the pharmaceutical industry[5].

The company's mission is clear:

"Otsuka-people creating new products for better health worldwide."[5]

This philosophy drives Otsuka's commitment to innovation and perseverance in tackling complex health challenges.

Market Position

Global Presence

Otsuka's market position is strengthened by its extensive global network. With operations in 28 countries and a workforce of approximately 47,000 employees worldwide, the company has established a strong international presence[6]. This global reach allows Otsuka to tap into diverse markets and leverage regional expertise.

Financial Performance

In 2022, Otsuka's pharmaceutical segment generated impressive revenue of approximately ¥1.39 trillion, marking an 8.6% year-over-year increase[4]. This growth demonstrates the company's strong market position and ability to capitalize on emerging opportunities.

Key Therapeutic Areas

Otsuka focuses on several key therapeutic areas, positioning itself as a leader in:

1. Central Nervous System (CNS) disorders
2. Nephrology
3. Oncology
4. Cardiovascular diseases
5. Ophthalmology

By concentrating on these areas, particularly CNS and nephrology, Otsuka has carved out a niche in addressing unmet medical needs[3].

Strengths and Competitive Advantages

Innovation and R&D Focus

One of Otsuka's primary strengths lies in its commitment to research and development. The company has allocated a substantial R&D budget of approximately ¥300 billion for 2023[4]. This significant investment in innovation allows Otsuka to maintain a robust pipeline of potential breakthrough treatments.

Diverse Product Portfolio

Otsuka's product range extends beyond pharmaceuticals, encompassing:

• Clinical nutrition
• Diagnostics
• Medical devices
• Fine chemicals

This diversification helps mitigate risks associated with dependency on a single product line or therapeutic area[3].

Digital Health Initiatives

Recognizing the transformative potential of digital technology in healthcare, Otsuka has positioned itself at the forefront of digital innovation. The company is developing novel solutions to address challenges faced by individuals living with serious mental illnesses, potentially revolutionizing patient care[2].

Strong Brand Recognition

Otsuka has established strong brand recognition, particularly in the mental health market. This reputation helps the company maintain its competitive edge and build trust among healthcare professionals and patients[4].

Strategic Insights

Focus on Unmet Medical Needs

Otsuka's strategy of targeting areas with significant unmet medical needs has proven successful. For instance, the company's treatment for autosomal dominant polycystic kidney disease (ADPKD) was the first of its kind when approved in 2018 and remains the only available product[2].

Long-term Perseverance

Otsuka's willingness to invest in long-term research, even for indications requiring extended clinical studies, sets it apart from competitors. This approach has led to major breakthroughs, particularly in CNS and nephrology[2].

Strategic Partnerships

Collaborations play a crucial role in Otsuka's growth strategy. In 2023, the company announced a partnership with Amgen to co-develop innovative therapies, potentially generating additional revenues of up to ¥150 billion by 2026[4].

Market Expansion

Otsuka is actively pursuing geographical expansion, particularly in emerging markets. The company aims to achieve ¥200 billion in revenue from these expansions by 2025[4].

Challenges and Risks

Industry Competition

The pharmaceutical sector is highly competitive, with both established players and new entrants vying for market share. Otsuka must continually innovate to maintain its position[4].

Regulatory Environment

As with all pharmaceutical companies, Otsuka faces challenges related to stringent regulations and potential changes in healthcare policies that could impact drug approval processes and market access[4].

Supply Chain Disruptions

Global supply chain challenges have affected raw material sourcing, potentially impacting production capabilities[4].

Clinical Trial Outcomes

The success of ongoing clinical trials is crucial for Otsuka's future performance. Unfavorable results could delay product launches and affect financial performance[4].

Future Outlook

Revenue Growth Projections

Analysts forecast that Otsuka's overall revenue will grow at a compound annual growth rate (CAGR) of 6% through 2025. This growth is expected to be driven primarily by strong demand in the pharmaceutical segment and innovative product offerings[4].

Earnings Per Share Estimates

Earnings per share (EPS) are projected to rise from ¥305 in 2022 to approximately ¥420 by 2025, indicating strong financial health and growth potential[4].

Pipeline Developments

Otsuka continues to invest in its product pipeline, with a focus on CNS disorders, nephrology, and oncology. Recent innovations include:

• New formulation of Abilify in Japan
• Introduction of Rexulti for depression treatment in various markets
• Advancements in digital health technologies[4]

Corporate Social Responsibility

Otsuka's approach to social impact is grounded in the idea of creating better health worldwide by addressing issues that only Otsuka can solve[7]. This commitment to corporate social responsibility enhances the company's reputation and aligns with growing consumer expectations for ethical business practices.

Key Takeaways

1. Otsuka holds a strong market position in key therapeutic areas, particularly CNS disorders and nephrology.
2. The company's commitment to innovation and R&D investment drives its competitive advantage.
3. Otsuka's diverse product portfolio and global presence contribute to its financial stability and growth potential.
4. Strategic partnerships and market expansions are key components of Otsuka's growth strategy.
5. The company faces challenges related to industry competition, regulatory changes, and supply chain disruptions.
6. Analysts project continued revenue growth and increased earnings per share for Otsuka through 2025.
7. Otsuka's focus on addressing unmet medical needs and long-term perseverance in research sets it apart in the pharmaceutical landscape.

FAQs

1. What are Otsuka's main therapeutic focus areas? Otsuka primarily focuses on central nervous system disorders, nephrology, oncology, cardiovascular diseases, and ophthalmology.

2. How does Otsuka's R&D investment compare to industry standards? Otsuka has allocated a substantial R&D budget of approximately ¥300 billion for 2023, demonstrating a significant commitment to innovation compared to many industry peers.

3. What is Otsuka's approach to digital health? Otsuka is investing in digital health technologies to develop novel solutions for mental health challenges, aiming to revolutionize patient care through data-driven insights and improved patient-provider communication.

4. How is Otsuka addressing the challenge of diversity in clinical trials? Otsuka recognizes the importance of diversity in clinical research and is working to ensure that its research programs and clinical trials are representative of the diverse patient populations who will receive their therapies.

5. What are the key growth drivers for Otsuka in the coming years? Otsuka's growth is expected to be driven by product innovations, market expansions (particularly in emerging markets), strategic partnerships, and continued investment in key therapeutic areas.

Sources cited: [1] https://www.otsuka.co.jp/en/company/overview/ [2] https://www.otsuka-us.com/sites/g/files/qhldwo9936/files/media/static/01US23EBC0006-Otsuka-Economic-Impact-Report.pdf [3] https://www.otsuka.com/en/rd/business/pharmaceuticals/ [4] https://dcfmodeling.com/blogs/health/4768t-financial-health [5] https://www.otsuka-us.com/who-we-are [6] https://www.otsuka-us.com/discover/otsuka-earns-designation-as-a-great-place-to-work [7] https://www.otsuka-us.com/social-impact