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Last Updated: March 22, 2025

Shionogi Inc Company Profile


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Summary for Shionogi Inc
International Patents:73
US Patents:3
Tradenames:5
Ingredients:5
NDAs:5
Patent Litigation for Shionogi Inc: See patent lawsuits for Shionogi Inc

Drugs and US Patents for Shionogi Inc

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Shionogi Inc COGNEX tacrine hydrochloride CAPSULE;ORAL 020070-001 Sep 9, 1993 DISCN No No ⤷  Try for Free ⤷  Try for Free
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes 9,949,982 ⤷  Try for Free Y ⤷  Try for Free
Shionogi Inc RYBIX ODT tramadol hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021693-001 May 5, 2005 DISCN No No ⤷  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
Showing 1 to 3 of 3 entries

Expired US Patents for Shionogi Inc

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Shionogi Inc COGNEX tacrine hydrochloride CAPSULE;ORAL 020070-004 Sep 9, 1993 4,816,456 ⤷  Try for Free
Shionogi Inc COGNEX tacrine hydrochloride CAPSULE;ORAL 020070-001 Sep 9, 1993 4,631,286 ⤷  Try for Free
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 7,294,342 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries
Paragraph IV (Patent) Challenges for SHIONOGI INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Lotion 5% ➤ Subscribe 2016-04-11
➤ Subscribe Injection 250 mg/vial and 500 mg/vial ➤ Subscribe 2011-10-11

Supplementary Protection Certificates for Shionogi Inc Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2960244 122020000060 Germany ⤷  Try for Free PRODUCT NAME: CEFIDEROCOL; REGISTRATION NO/DATE: EU/1/20/1434 20200423
2960244 2020035 Norway ⤷  Try for Free PRODUCT NAME: CEFIDEROKOL, EVENTUELT PA FORMEN AV ET FARMASOEYTISK AKSEPTABELT SALT ELLER SOLVAT; REG. NO/DATE: EU/1/20/1434 20200508
1425001 SPC/GB14/034 United Kingdom ⤷  Try for Free PRODUCT NAME: VILANTEROL OR SALTS OR SOLVATES THEREOF (I.E., 4-((1R)-2-((6-(2-((2,6-DICHLOROBENZYL)OXY)ETHOXY)HEXYL)AMINO)-1-HYDROXYETHYL)-2-(HYDROXYMETHYL)PHENOL OR SALTS OR SOLVATES THEREOF); REGISTERED: UK EU/1/13/886/001 20131114; UK EU/1/13/886/002 20131114; UK EU/1/13/886/003 20131114; UK EU/1/13/886/004 20131114; UK EU/1/13/886/005 20131114; UK EU/1/13/886/006 20131114
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 3 of 3 entries
Similar Applicant Names
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Here is a list of applicants with similar names.

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

In the ever-evolving pharmaceutical industry, Shionogi Inc. stands out as a formidable player with a rich history and a strong focus on innovation. Let's dive into a comprehensive analysis of Shionogi's market position, strengths, and strategic insights that shape its competitive landscape.

Shionogi's Market Position

Shionogi Inc., a Japanese pharmaceutical company with a global presence, has carved out a significant niche in the industry. As of 2023, the company boasts a market size of approximately 10 trillion yen, positioning it as a key player in the world's third-largest pharmaceutical market[8]. This impressive standing is a testament to Shionogi's commitment to research and development, as well as its ability to adapt to changing market dynamics.

Global Footprint and Revenue

Shionogi's influence extends far beyond its Japanese roots. The company has established a strong presence across Asia, North America, and Europe. In 2022, Shionogi generated an impressive $3.1 billion in revenue, showcasing its ability to compete on a global scale[9]. This financial performance underscores the company's robust product portfolio and effective market strategies.

European Expansion

Shionogi's European operations have seen significant growth in recent years. The company now boasts five fully operational affiliate offices in key European markets: the UK, France, Italy, Spain, and Germany. With over 300 employees and a headquarters in the Netherlands, Shionogi Europe has established a strong foothold in some of the continent's largest pharmaceutical markets[9].

Shionogi's Core Strengths

Shionogi's success in the competitive pharmaceutical landscape can be attributed to several key strengths that set it apart from its rivals.

Research and Development Prowess

At the heart of Shionogi's competitive advantage lies its formidable R&D capabilities. The company's commitment to innovation is evident in its substantial investment in research and development. In 2022, Shionogi allocated $470 million to R&D efforts, fueling over 30 ongoing development programs[9]. This significant investment underscores the company's dedication to shaping the future of healthcare through cutting-edge research.

Expertise in Infectious Diseases

Shionogi has built a solid reputation for its expertise in infectious diseases, a field that has become increasingly critical in recent years. The company's long-standing focus on this area has resulted in the development of several groundbreaking drugs and therapies.

During our more than sixty years of research and development in the field of infectious disease, we have delivered therapeutic drugs for various infectious diseases[2].

This extensive experience has positioned Shionogi as a leader in addressing global health challenges, particularly in the fight against antimicrobial resistance (AMR).

Innovative Drug Discovery Capabilities

Shionogi's strength in research stems from its highly efficient Structure Activity Relationship (SAR) engine for small-molecule drug discovery. The company's competitive edge is rooted in the technological prowess of its teams in medicinal chemistry, pharmacology, and safety and pharmacokinetics[5]. This collaborative approach has enabled Shionogi to move swiftly through the SAR cycle, resulting in the launch of five in-house originated products onto global markets during the previous SGS2020 Medium-Term Business Plan[5].

Strategic Insights and Future Direction

Shionogi's strategic approach to the pharmaceutical market is characterized by a focus on innovation, global expansion, and addressing unmet medical needs.

Focus on Antimicrobial Resistance

One of Shionogi's key strategic priorities is combating antimicrobial resistance (AMR), a growing global health threat. The company has made significant strides in this area with the development of cefiderocol (Fetroja), a treatment against multidrug-resistant Gram-negative bacterial infections[1]. Shionogi's commitment to addressing AMR is further evidenced by its efforts to improve global access to cefiderocol, particularly in low- and middle-income countries through collaborations with organizations like GARDP and CHAI[1].

Diversification of Product Portfolio

While maintaining its strength in infectious diseases, Shionogi is also expanding its focus to other therapeutic areas. The company is actively developing products in fields such as pain management and women's health[9]. This diversification strategy aims to broaden Shionogi's market reach and reduce dependence on any single therapeutic area.

Embracing New Technologies and Modalities

Shionogi recognizes the importance of staying at the forefront of pharmaceutical innovation. The company is investing in new modalities and technologies beyond its traditional small molecule expertise. This includes exploring areas such as vaccines, antibodies, peptides, and nucleic acids, as well as leveraging digital approaches like AI and automation in the drug discovery process[3].

Competitive Landscape and Market Challenges

Despite its strong position, Shionogi faces several challenges in the highly competitive pharmaceutical market.

Intense Global Competition

The pharmaceutical industry is notoriously competitive, with numerous firms vying for market share in similar therapeutic areas. Shionogi faces stiff competition not just from domestic players in Japan but also from international pharmaceutical giants[4]. The global pharmaceutical market is projected to reach $1.57 trillion by 2023, intensifying competitive pressures[4].

Regulatory Challenges

Like all pharmaceutical companies, Shionogi must navigate a complex regulatory landscape. The company must adhere to stringent regulations set by various health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)[4]. Recent regulatory shifts in Japan regarding price reductions on drugs can directly affect Shionogi's revenue streams, adding another layer of complexity to its operations.

Market Volatility and External Factors

The pharmaceutical industry is susceptible to various external factors that can impact market conditions. Economic downturns, global health emergencies (such as the COVID-19 pandemic), and shifts in healthcare policies can all affect sales and disrupt product pipelines[4]. Shionogi must remain agile and responsive to these external pressures to maintain its competitive edge.

Growth Opportunities and Future Outlook

Despite the challenges, Shionogi is well-positioned to capitalize on several growth opportunities in the coming years.

Expansion of Global Reach

Shionogi is actively working to expand its global footprint, with a particular focus on the North American market. The company is targeting a 10% CAGR through 2025, driven by the launch of new products in this region[4]. This expansion strategy aims to reduce Shionogi's dependence on the Japanese market and tap into new sources of growth.

Strategic Acquisitions and Partnerships

To enhance its pipeline and access cutting-edge therapies, Shionogi is pursuing strategic acquisitions and partnerships. The company's recent acquisition of a biotechnology firm in the U.S. for $300 million is a prime example of this strategy[4]. Such moves position Shionogi to stay competitive in the rapidly evolving pharmaceutical landscape.

Continued Investment in R&D

Shionogi remains committed to investing heavily in research and development. In the fiscal year 2023, the company's R&D expenditure was approximately ¥54.4 billion, representing about 20% of total revenue[4]. This substantial investment in innovation is expected to fuel the development of new products and strengthen Shionogi's competitive position in the long term.

Key Takeaways

  • Shionogi Inc. has established itself as a significant player in the global pharmaceutical industry, with a strong presence in Japan and expanding operations in Europe and North America.
  • The company's core strengths lie in its robust R&D capabilities, expertise in infectious diseases, and innovative drug discovery processes.
  • Shionogi's strategic focus on combating antimicrobial resistance and diversifying its product portfolio positions it well for future growth.
  • Despite facing challenges such as intense competition and regulatory pressures, Shionogi continues to invest heavily in R&D and pursue global expansion opportunities.
  • The company's commitment to innovation, strategic partnerships, and addressing unmet medical needs suggests a promising outlook for its future in the pharmaceutical landscape.

FAQs

  1. Q: What is Shionogi's primary area of expertise in the pharmaceutical industry? A: Shionogi has a strong focus on infectious diseases, particularly in developing treatments for antimicrobial resistance (AMR). However, the company is also expanding into other therapeutic areas such as pain management and women's health.

  2. Q: How does Shionogi compare to other major pharmaceutical companies in terms of R&D investment? A: Shionogi invests significantly in R&D, allocating approximately 20% of its total revenue to research and development activities. This level of investment is competitive within the industry and demonstrates the company's commitment to innovation.

  3. Q: What are some of Shionogi's key products in the global market? A: Some of Shionogi's notable products include Fetroja (cefiderocol) for treating multidrug-resistant Gram-negative bacterial infections, and previously launched products like Tivicay (anti-HIV agent) and Xofluza (influenza drug).

  4. Q: How is Shionogi addressing the challenge of antimicrobial resistance? A: Shionogi is actively developing new antibiotics and improving global access to treatments like cefiderocol. The company collaborates with organizations like GARDP and CHAI to provide access to its AMR treatments in low- and middle-income countries.

  5. Q: What are Shionogi's plans for future growth and expansion? A: Shionogi is focusing on expanding its global reach, particularly in the North American market. The company is also investing in new technologies and modalities, pursuing strategic acquisitions and partnerships, and continuing to invest heavily in R&D to drive future growth.

Sources cited: [1] https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/annual-report-integrated-report/pdf/ir2024/Shionogi_24e_1108.pdf [2] https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/annual-report-integrated-report/pdf/ir2023/chapter1_e_2023_1031.pdf [3] https://www.shionogi.com/global/en/innovation/randd/overview-of-randd/randd-vision-and-strategy.html [4] https://dcf.fm/blogs/health/4507t-financial-health [5] https://www.shionogi.com/global/en/company/strength.html [8] https://info.jelper.co/post/2410-japanese-pharmaceutical-industry-employment-en [9] https://www.shionogi.com/eu/en/innovation/strategic-partnering-in-europe/current-capabilities.html

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