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Last Updated: December 15, 2025

Shionogi Company Profile


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Summary for Shionogi
International Patents:75
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 FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes 9,949,982 ⤷  Get Started Free Y ⤷  Get Started Free
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes 9,238,657 ⤷  Get Started Free Y Y ⤷  Get Started Free
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-002 Oct 5, 2010 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Shionogi UROBAK sulfamethoxazole TABLET;ORAL 087307-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Shionogi Inc RYBIX ODT tramadol hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021693-001 May 5, 2005 DISCN No No ⤷  Get Started Free ⤷  Get Started 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 Shionogi

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-002 Oct 5, 2010 8,247,402 ⤷  Get Started Free
Shionogi Inc RYBIX ODT tramadol hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021693-001 May 5, 2005 5,464,632 ⤷  Get Started Free
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 6,139,859 ⤷  Get Started Free
Shionogi Inc COGNEX tacrine hydrochloride CAPSULE;ORAL 020070-003 Sep 9, 1993 4,631,286 ⤷  Get Started Free
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-002 Oct 5, 2010 5,317,016 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SHIONOGI drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 250 mg/vial and 500 mg/vial ➤ Subscribe 2011-10-11
➤ Subscribe Lotion 5% ➤ Subscribe 2016-04-11

Supplementary Protection Certificates for Shionogi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1307486 SPC/GB12/030 United Kingdom ⤷  Get Started Free PRODUCT NAME: CYCLO((4R)-4-(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-)), PASIREOTIDE, OR SALTS THEREOF; REGISTERED: UK EU/1/12/753/001-012 20120424
1425001 SPC/GB14/034 United Kingdom ⤷  Get Started 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
2960244 C202030051 Spain ⤷  Get Started Free PRODUCT NAME: CEFIDEROCOL, OPCIONALMENTE EN FORMA DE UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLE.; NATIONAL AUTHORISATION NUMBER: EU/1/20/1434; DATE OF AUTHORISATION: 20200423; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1434; DATE OF FIRST AUTHORISATION IN EEA: 20200423
0306228 SPC/GB01/002 United Kingdom ⤷  Get Started Free 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
2187879 SPC/GB17/031 United Kingdom ⤷  Get Started Free PRODUCT NAME: 1-CHLORO-4-(SS-D-GLUCOPYRANOS-1-YL)-2-(4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL)-BENZENE (I.E. EMPAGLIFLOZIN) IN COMBINATION WITH 1-((4 METHYL-QUINAZOLIN-2-YL)METHYL)-3-METHYL-7-(2-BUTYN-1-YL)-8-(3-(R)-AMINO-PIPERIDIN-1-YL)-XANTHINE (I.E. LINAGLIPTIN) OR A P; REGISTERED: UK PLGB 14598/0191 (GB) 20161115; UK EU/1/16/1146/014(NI) 20161115; UK EU/1/16/1146/015(NI) 20161115; UK EU/1/16/1146/016(NI) 20161115; UK EU/1/16/1146/017(NI) 20161115; UK EU/1/16/1146/018(NI) 20161115; UK EU/1/16/1146/007(NI) 20161115; UK EU/1/16/1146/001(NI) 20161115; UK EU/1/16/1146/013(NI) 20161115; UK EU/1/16/1146/002(NI) 20161115; UK EU/1/16/1146/003(NI) 20161115; UK EU/1/16/1146/004(NI) 20161115; UK...
>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.

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

Last updated: July 31, 2025

Introduction

Shionogi & Co., Ltd. stands as a notable player within Japan's competitive pharmaceutical sector, distinguished by its focus on infectious diseases, antimicrobial agents, and specialty therapeutics. As the pharmaceutical landscape becomes increasingly innovative and demanding, evaluating Shionogi’s market positioning, strategic strengths, and growth prospects provides crucial insights for stakeholders. This analysis synthesizes Shionogi’s current standing amidst global and regional competitors, exploring its core competencies, market strategies, and future outlook.

Market Position of Shionogi

Global and Regional Footprint

Although predominantly rooted in Japan, Shionogi has expanded its influence within Asia and seeks broader international penetration. Its domestic market remains its core revenue generator, bolstered by strong brand recognition for its infectious disease treatments, notably in antimicrobial and antiviral segments. Internationally, Shionogi has adopted strategic collaborations and licensing agreements to diversify its portfolio and extend its geographic reach, especially within emerging markets.

Competitive Standing in Niche Therapeutic Areas

Shionogi’s expertise concentrates on infectious disease therapeutics, an area characterized by high clinical need and competitive barriers. Its flagship product, Cefibuten for bacterial infections and Baloxavir Marboxil for influenza, exemplifies its focus on pathogen-specific therapeutics with high barriers to biosimilarity and generics. Such specialization establishes its reputation in niche segments less crowded by giants like Pfizer, Roche, or GSK.

Market Share and Revenue Contribution

As per the latest financial disclosures, Shionogi’s revenue predominantly stems from antimicrobial and antiviral drug sales, which collectively account for approximately 60% of total revenue. Its strategic focus on areas with high unmet needs affords it stability amidst generic erosion in other segments, ensuring a resilient market position.

Strengths of Shionogi

1. Niche Therapeutic Expertise

Shionogi’s concentrated investment in infectious diseases offers a competitive advantage. Its research and development (R&D) pipeline is heavily tailored toward novel antivirals, antibiotics, and treatments for rare diseases, enabling differentiation in markets with significant unmet needs.

2. Robust R&D Capabilities

The company’s focus on innovation is reflected in its strong R&D pipeline, with over 20 candidates in various trial phases. Notable recent launches like Xofluza (Baloxavir Marboxil) have positioned Shionogi as an innovative leader in antiviral therapeutics. This strategic emphasis ensures a steady flow of differentiated products to fuel future growth.

3. Strategic Collaborations and Licensing

Shionogi’s alliance with international partners, such as its licensing agreement with Merck for baloxavir, enhances its market access and accelerates product development. Such collaborations facilitate technology transfer, reduce R&D costs, and expand global footprint.

4. Focused Portfolio with High Barriers to Entry

The company’s focus on high-value, pathogen-specific drugs minimizes direct competition with large, diversified pharmaceutical conglomerates. Its drugs often possess unique mechanisms of action, providing sustainable competitive advantages.

5. Commitment to Specialty and Rare Diseases

Shionogi’s diversification into rare diseases and specialty therapeutics positions it in growing segments with less generic competition and greater pricing power, further shoreing its market resilience.

Strategic Insights

1. International Expansion and Market Diversification

To reduce dependence on Japan’s mature market, Shionogi should pursue accelerated international expansion, particularly through licensing, joint ventures, and targeted acquisitions. The Asia-Pacific region, with its rising infectious disease burden, presents strategic growth opportunities.

2. Innovation Leadership in Antivirals

Investing further in antiviral R&D, especially amid the ongoing threat of pandemics and emerging viral threats, can solidify Shionogi’s position as a leader in infectious disease therapeutics. Developing broad-spectrum antivirals or drugs targeting resistant strains could open new markets.

3. Enhancing Manufacturing and Supply Chain Resilience

Given the global supply chain disruptions impacting pharmaceutical manufacturing, Shionogi must strengthen its production capabilities and diversify supply sources, ensuring continuous product availability and satisfying global demand.

4. Digital Transformation and Data-Driven Approaches

Leveraging digital health technologies, real-world evidence, and AI-driven drug discovery will enable faster development cycles, personalized medicine initiatives, and improved market access strategies.

5. Balancing Growth with Patent and Regulatory Strategies

Prolonging patent exclusivity and navigating evolving regulatory landscapes, particularly in emerging markets, will be vital to maintaining a competitive edge.

Challenges and Risks

  • Market Maturity: Japan’s aging population might lead to stagnation in domestic markets, pressing Shionogi to innovate and expand abroad.
  • Generic Competition: As patents expire, maintaining profitability will require effective lifecycle management and portfolio diversification.
  • Regulatory Environment: Stringent approvals and pricing controls in key markets pose ongoing challenges for timely product launches.
  • Competitive Innovation: Larger pharmaceutical firms with broader resources may enter niche segments, intensifying competition.

Future Outlook

Shionogi’s strategic focus on infectious diseases, combined with its robust R&D pipeline and partner collaborations, positions it favorably within its core markets. Its ability to maintain innovation leadership and expand internationally will determine its long-term growth trajectory. Continuous adaptation to global health needs and market dynamics remains critical.

Key Takeaways

  • Shionogi’s specialized focus on infectious diseases and antibiotics provides a resilient market position amid intense competition.
  • Investment in R&D and strategic collaborations underpin its innovation pipeline and geographic expansion ambitions.
  • Diversification into rare and specialty therapeutics offers growth within high-margin, less competitive segments.
  • To sustain competitiveness, Shionogi must accelerate international expansion, particularly within emerging markets, and bolster manufacturing resilience.
  • The company’s future success hinges on its ability to innovatively address global infectious disease challenges and adapt to evolving regulatory and market environments.

FAQs

1. What distinguishes Shionogi from other pharmaceutical companies?
Shionogi’s core differentiation lies in its deep specialization in infectious diseases, antimicrobial agents, and antivirals, enabling it to develop highly differentiated therapies with high market barriers.

2. What are Shionogi’s flagship products?
The most notable is Xofluza (Baloxavir Marboxil), a pioneering antiviral for influenza, alongside its established antibiotics like Cefibuten. Its focus on innovative, pathogen-specific therapeutics shapes its portfolio.

3. How is Shionogi expanding internationally?
Through licensing agreements, strategic alliances, and targeted market entry in Asia and emerging markets, Shionogi aims to diversify its revenue streams and extend its global footprint.

4. What are the main risks facing Shionogi?
Risks include generic erosion post-patent expiry, regulatory challenges, high R&D costs, and intensified competition from larger firms entering niche infectious disease markets.

5. What strategic initiatives could future-proof Shionogi’s growth?
Focusing on expanding its antiviral R&D pipeline, strengthening international presence, leveraging digital health tools, and managing patent exclusivities are key strategies for sustaining growth.


Sources:

  1. Shionogi Annual Report 2022
  2. IQVIA, Global Innovative Pharmaceutical Market Insights 2022
  3. Company Press Releases and Product Data Sheets
  4. Industry Analyses from EvaluatePharma and Pharmaboardroom

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.