Shionogi Company Profile

What is the competitive landscape for SHIONOGI

SHIONOGI has eight approved drugs.

There are three US patents protecting SHIONOGI drugs.

There are seventy-three patent family members on SHIONOGI drugs in thirty-eight countries and thirty-four supplementary protection certificates in sixteen countries.

Summary for Shionogi

International Patents:	73
US Patents:	3
Tradenames:	8
Ingredients:	7
NDAs:	8
Patent Litigation for Shionogi:	See patent lawsuits for Shionogi

Drugs and US Patents for Shionogi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007		DISCN	Yes	No
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010		DISCN	Yes	No
Shionogi Inc	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445-001	Nov 14, 2019		RX	Yes	Yes	9,238,657		Y	Y
Shionogi Inc	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445-001	Nov 14, 2019		RX	Yes	Yes
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005		DISCN	No	No
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009		DISCN	Yes	No
Shionogi	UROPLUS DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	071816-001	Sep 28, 1987		DISCN	No	No

Expired US Patents for Shionogi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi Inc	COGNEX	tacrine hydrochloride	CAPSULE;ORAL	020070-004	Sep 9, 1993	4,816,456
Shionogi Inc	COGNEX	tacrine hydrochloride	CAPSULE;ORAL	020070-001	Sep 9, 1993	4,631,286
Shionogi Inc	COGNEX	tacrine hydrochloride	CAPSULE;ORAL	020070-003	Sep 9, 1993	4,631,286
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005	5,464,632
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	7,294,342
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	6,793,931
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	6,139,859

Paragraph IV (Patent) Challenges for SHIONOGI drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	250 mg/vial and 500 mg/vial		2011-10-11
	Lotion	5%		2016-04-11

International Patents for Shionogi Drugs

Country	Patent Number	Estimated Expiration
Brazil	PI0921701
China	106687116
European Patent Office	3189841
France	20C1050
Philippines	12017500435
Serbia	55365
Slovenia	2960244

Supplementary Protection Certificates for Shionogi Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2960244	2020/044	Ireland		PRODUCT NAME: CEFIDEROCOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; NAT REGISTRATION NO/DATE: EU/1/20/1434 20200424; FIRST REGISTRATION NO/DATE: EU/1/20/1434 20200424
2960244	2020C/541	Belgium		PRODUCT NAME: CEFIDEROCOL, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH ZOUT OF SOLVAAT; AUTHORISATION NUMBER AND DATE: EU/1/20/1434 20200424
2960244	2090041-1	Sweden		PRODUCT NAME: CEFIDEROKOL; REG. NO/DATE: EU/1/20/1434 20200424
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
0528678	CR 2009 00003	Denmark		PRODUCT NAME: DORIPENEM, HERUNDER DORIPENEMMONOHYDRAT; REG. NO/DATE: EU/1/08/467/001 20080725
0306228	SPC/GB01/002	United Kingdom		PRODUCT NAME: 5-(4-(2-(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY) BENZYL)-2,4-THIAZOLIDINEDIONE, "ROSIGLITAZONE" ITS TAUTOMERS, PHARMACEUTICALLY ACCEPTABLE SALTS, SUCH AS THE MALEATE, AND PHARMACEUTICALLY ACCEPTABLE SOLVATES.; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925

Similar Applicant Names

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

• Shionogi
• Shionogi Inc

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

In the ever-evolving pharmaceutical industry, Shionogi & Co., Ltd. stands out as a formidable player with a rich history and a focused approach to drug development. This Japanese pharmaceutical giant has carved a niche for itself, particularly in the realm of infectious diseases. Let's dive deep into Shionogi's market position, strengths, and strategic insights to understand its competitive landscape.

The Shionogi Story: A Legacy of Innovation

Shionogi's journey began in 1878, marking nearly a century and a half of pharmaceutical excellence. The company has consistently demonstrated its commitment to innovation and quality, evolving from a local Japanese enterprise to a global pharmaceutical powerhouse.

From Local Roots to Global Reach

Shionogi's transformation from a domestic player to an international contender is a testament to its strategic vision. The company has expanded its footprint across Asia, North America, and Europe, generating an impressive $3.1 billion in revenue in 2022[10]. This global presence has not only diversified its market but also enhanced its ability to address global health challenges.

A Focus on Infectious Diseases

One of Shionogi's most distinctive features is its unwavering focus on infectious diseases. For over 60 years, the company has been at the forefront of research and development in this critical area of healthcare[6]. This long-standing commitment has resulted in a robust portfolio of antibiotics and antiviral medications that have made significant impacts on global health.

"Shionogi has conducted research and development in infectious diseases for over 60 years, bringing a huge number of drugs for infectious diseases to market along the way."[6]

Shionogi's Market Position: A Niche Player with Global Impact

In the competitive pharmaceutical landscape, Shionogi has carved out a unique position for itself. While it may not be the largest player in terms of overall market share, its specialized focus and innovative approach have earned it a respected place in the industry.

The Numbers Speak: Market Size and Growth

As of 2023, Shionogi's revenue is projected to grow from ¥260 billion to ¥300 billion by 2025, reflecting a compound annual growth rate (CAGR) of approximately 7%[4]. This steady growth trajectory underscores the company's resilience and strategic planning in a highly competitive market.

Global Recognition and Partnerships

Shionogi's expertise in infectious diseases has not gone unnoticed. The company has formed strategic partnerships with global pharmaceutical giants, enhancing its reach and impact. A notable example is its collaboration with GlaxoSmithKline (GSK) in developing HIV treatments, which has resulted in groundbreaking medications like Tivicay[6].

Shionogi's Strengths: The Pillars of Success

Shionogi's competitive edge stems from several key strengths that set it apart in the pharmaceutical industry.

Innovative R&D Approach

At the heart of Shionogi's success is its innovative approach to research and development. The company's highly efficient SAR (Structure Activity Relationship) engine for small-molecule drug discovery is a cornerstone of its R&D capabilities[6]. This technological prowess, combined with strong teamwork across various scientific disciplines, enables Shionogi to move swiftly through the drug development cycle.

Robust Product Pipeline

Shionogi boasts a strong product pipeline with over 15 candidates in late-stage development[4]. This robust pipeline not only ensures a steady stream of potential new products but also demonstrates the company's commitment to addressing unmet medical needs.

Financial Health and Investment in Innovation

Shionogi's financial strategy reflects its commitment to innovation. In the fiscal year 2023, the company invested approximately ¥54.4 billion in R&D, representing about 20% of its total revenue[4]. This significant investment in research underscores Shionogi's long-term vision and dedication to developing breakthrough therapies.

Strategic Insights: Navigating the Future

Shionogi's strategic approach to the pharmaceutical market offers valuable insights into its future trajectory and potential for continued success.

Focus on High-Need Areas

Shionogi's strategic focus on infectious diseases, particularly in an era where many pharmaceutical companies are withdrawing from this field, positions it uniquely in the market. The company's continued investment in antibacterial and antifungal R&D has been recognized in the Antimicrobial Resistance Benchmark 2020 survey, where Shionogi was noted for having the highest annual ratio of R&D investment in this area among surveyed companies[6].

Expansion into New Markets

While maintaining its strength in the Japanese market, Shionogi is actively expanding its global footprint. The company is particularly focused on growth in the North American market, targeting a 10% CAGR through 2025[4]. This expansion strategy is crucial for diversifying revenue streams and reducing dependence on any single market.

Embracing Digital Transformation

Shionogi is not just focusing on traditional pharmaceutical development but is also embracing digital transformation. In 2023, Japan's Ministry of Economy, Trade and Industry (METI) recognized Shionogi as a "Noteworthy DX Company,"[7] highlighting its efforts to integrate digital technologies into its operations and strategy.

Competitive Landscape: Shionogi in the Global Arena

To truly understand Shionogi's position, we must consider its place in the broader pharmaceutical landscape.

Key Competitors

While Shionogi has carved out a niche for itself, it faces competition from both domestic and international pharmaceutical giants. Companies like Takeda Pharmaceutical, Daiichi Sankyo, and Astellas Pharma are significant competitors in the Japanese market, while global players like Pfizer, Novartis, and Sanofi pose challenges in international markets[8].

Competitive Advantages

Shionogi's competitive advantages lie in its specialized focus, strong R&D capabilities, and robust intellectual property portfolio. The company's established reputation in Japan and growing recognition in global markets give it a solid foundation for future growth[4].

Future Outlook: Challenges and Opportunities

As Shionogi looks to the future, it faces both challenges and opportunities that will shape its trajectory in the pharmaceutical industry.

Challenges

1. Increasing R&D Costs: The rising costs of drug development pose a significant challenge, requiring careful resource allocation and strategic planning.

2. Regulatory Hurdles: Navigating the complex regulatory landscape across different markets remains a constant challenge.

3. Market Competition: Intense competition from both established players and emerging biotech companies requires continuous innovation and market differentiation.

Opportunities

1. Growing Demand for Infectious Disease Treatments: The ongoing global focus on infectious diseases, highlighted by the COVID-19 pandemic, presents significant opportunities for Shionogi's specialized portfolio.

2. Expansion in Emerging Markets: There's potential for growth in emerging pharmaceutical markets, particularly in Asia and Africa.

3. Digital Health Integration: The integration of digital health technologies offers new avenues for drug development, patient care, and market expansion.

Key Takeaways

• Shionogi has established itself as a niche player in the pharmaceutical industry, with a strong focus on infectious diseases.
• The company's innovative R&D approach and robust product pipeline are key strengths driving its competitive position.
• Shionogi's strategic focus on high-need areas and expansion into new markets positions it well for future growth.
• The company faces challenges in terms of increasing R&D costs and market competition but also has significant opportunities in the growing demand for infectious disease treatments and digital health integration.
• Shionogi's ability to navigate these challenges while capitalizing on its strengths will be crucial for its continued success in the global pharmaceutical landscape.

FAQs

1. What is Shionogi's primary focus in the pharmaceutical industry? Shionogi primarily focuses on infectious diseases, with a strong emphasis on developing antibiotics and antiviral medications.

2. How does Shionogi's R&D investment compare to other pharmaceutical companies? Shionogi has been recognized for having the highest annual ratio of R&D investment for anti-bacterial and anti-fungal agents among surveyed companies in the Antimicrobial Resistance Benchmark 2020 survey.

3. What are some of Shionogi's key products? Some of Shionogi's key products include the anti-HIV agent Tivicay and the influenza drug Xofluza.

4. How is Shionogi addressing the challenge of antimicrobial resistance? Shionogi continues to invest heavily in R&D for antibacterial and antifungal agents, maintaining its commitment to this field even as other companies withdraw.

5. What is Shionogi's strategy for international expansion? Shionogi is actively expanding its global footprint, with a particular focus on growth in the North American market, targeting a 10% CAGR through 2025.

Sources cited: [4] https://dcf.fm/blogs/health/4507t-financial-health [6] https://www.shionogi.com/global/en/company/strength.html [7] https://communities.sas.com/t5/SAS-Customer-Recognition-Awards/1st-Place-Winner-2024-Customer-Awards-SHIONOGI-amp-CO-LTD/ba-p/911924 [8] https://info.jelper.co/post/2410-japanese-pharmaceutical-industry-employment-en [10] https://www.shionogi.com/eu/en/innovation/strategic-partnering-in-europe/current-capabilities.html