Cefiderocol sulfate tosylate - Generic Drug Details

What are the generic drug sources for cefiderocol sulfate tosylate and what is the scope of patent protection?

Cefiderocol sulfate tosylate is the generic ingredient in one branded drug marketed by Shionogi Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cefiderocol sulfate tosylate has eighty-four patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for cefiderocol sulfate tosylate

International Patents:	84
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Patent Applications:	1
What excipients (inactive ingredients) are in cefiderocol sulfate tosylate?	cefiderocol sulfate tosylate excipients list
DailyMed Link:	cefiderocol sulfate tosylate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cefiderocol sulfate tosylate

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for cefiderocol sulfate tosylate

Drug Class

Cephalosporin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for cefiderocol sulfate tosylate

J01DI	Other cephalosporins and penems
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for cefiderocol sulfate tosylate

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			Y	Y
Shionogi Inc	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445-001	Nov 14, 2019		RX	Yes	Yes
Shionogi Inc	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445-001	Nov 14, 2019		RX	Yes	Yes			Y
Shionogi Inc	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445-001	Nov 14, 2019		RX	Yes	Yes
Shionogi Inc	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445-001	Nov 14, 2019		RX	Yes	Yes			Y	Y

International Patents for cefiderocol sulfate tosylate

Country	Patent Number	Title	Estimated Expiration
South Korea	20170043663
European Patent Office	2341053	CÉPHALOSPORINE POSSÉDANT UN GROUPE CATÉCHOL (CEPHALOSPORIN HAVING CATECHOL GROUP)
Poland	3190115
Taiwan	201609753
South Korea	20110090982	CEPHALOSPORIN HAVING CATECHOL GROUP
San Marino	T202100584
Canada	2736953	CEPHALOSPORINE POSSEDANT UN GROUPE CATECHOL (CEPHAROSPORINS HAVING A CATECHOL GROUP)

Supplementary Protection Certificates for cefiderocol sulfate tosylate

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	20C1050	France		PRODUCT NAME: CEFIDEROCOL, EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU D'UN SOLVATE; REGISTRATION NO/DATE: EU/1/20/1434 20200424
2960244	LUC00179	Luxembourg		PRODUCT NAME: CEFIDEROCOL, EVENTUELLEMENT SOUS LA FORME D'UN SEL OU D'UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/20/1434 20200424
2960244	CA 2020 00049	Denmark		PRODUCT NAME: CEFIDEROCOL, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT; REG. NO/DATE: EU/1/20/1434 20200424
2960244	CR 2020 00049	Denmark		PRODUCT NAME: CEFIDEROCOL, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT; REG. NO/DATE: EU/1/20/1434 20200424
2960244	PA2020530,C2960244	Lithuania		PRODUCT NAME: CEFIDEROKOLAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1434 20200423
2960244	PA2020530	Lithuania		PRODUCT NAME: CEFIDEROKOLAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1434 20200423

Market Dynamics and Financial Trajectory for Cefiderocol Sulfate Tosylate

Last updated: July 14, 2025

Introduction

In an era where antibiotic resistance threatens global health, Cefiderocol Sulfate Tosylate emerges as a critical weapon. Developed by Shionogi & Co., Ltd., this siderophore cephalosporin targets multi-drug resistant Gram-negative bacteria, addressing urgent needs in hospitals worldwide. As business professionals navigate pharmaceutical investments, understanding its market dynamics and financial path offers actionable insights into growth potential and risks.

Overview of Cefiderocol Sulfate Tosylate

Cefiderocol Sulfate Tosylate represents a breakthrough in antimicrobial therapy, approved by the U.S. Food and Drug Administration (FDA) in 2019 for complicated urinary tract infections and in 2020 for hospital-acquired pneumonia caused by susceptible Gram-negative pathogens. This drug exploits bacterial iron uptake mechanisms, delivering the active ingredient directly into cells and overcoming resistance barriers that plague traditional antibiotics.

Shionogi launched Cefiderocol under the brand name Fetroja in the U.S., with subsequent approvals in Europe and other regions. Its mechanism enhances efficacy against pathogens like Pseudomonas aeruginosa and Acinetobacter baumannii, positioning it as a last-resort option. Production involves sophisticated synthesis, including the tosylate salt form for improved stability and bioavailability, which drives manufacturing costs but ensures competitive edge.

The drug's patent landscape bolsters its market exclusivity. Shionogi holds core patents extending through 2035 in major markets, covering composition, methods of use, and formulations. This protection shields against generics, allowing premium pricing and sustained revenue streams.

Current Market Dynamics

The global market for antibiotics like Cefiderocol Sulfate Tosylate expands amid rising antimicrobial resistance. In 2023, the worldwide antibiotics market reached approximately $45 billion, with projections hitting $64 billion by 2030, according to industry analyses. Cefiderocol captures a niche within this, targeting resistant infections that conventional treatments fail.

Key drivers include increasing hospital admissions for severe infections and supportive regulatory frameworks. The FDA's Qualified Infectious Disease Product (QIDP) designation expedites Cefiderocol's development and review, granting market priority. In Europe, the European Medicines Agency (EMA) approved it in 2020, expanding access across the EU.

Competition remains limited but intensifies. Rivals like Merck's Zerbaxa and Pfizer's Zymar target similar indications, yet Cefiderocol's broad-spectrum activity sets it apart. Shionogi dominates this segment, holding about 15% of the U.S. carbapenem-resistant Enterobacteriaceae (CRE) treatment market as of 2023 data from IQVIA.

Pricing strategies reflect its value. In the U.S., a standard course costs around $3,000, justified by clinical outcomes and hospital cost savings from reduced treatment failures. However, reimbursement challenges in emerging markets limit penetration, with adoption strongest in North America and Europe, where it generated $150 million in sales for Shionogi in 2022.

Supply chain dynamics pose risks. Global manufacturing disruptions, such as those during the COVID-19 pandemic, affected active pharmaceutical ingredient (API) availability, highlighting vulnerabilities in Cefiderocol's production. Shionogi mitigates this through diversified suppliers and FDA-compliant facilities.

Financial Trajectory

Shionogi's investment in Cefiderocol underscores its financial ascent. Launched in 2019, the drug contributed $120 million in global sales by 2021, climbing to $180 million in 2023 amid expanded indications and market penetration. Analysts from Evaluate Pharma forecast revenues exceeding $500 million annually by 2028, driven by growing demand in Asia-Pacific regions like Japan and China.

Research and development expenditures fuel this trajectory. Shionogi allocated over $200 million to Cefiderocol's clinical trials and expansions, including Phase III studies for additional infections. These investments yield returns through premium pricing and partnerships, such as licensing deals with major distributors in Europe.

Profit margins hover around 40%, bolstered by patent protections and minimal direct competitors. However, generic threats loom post-2035, potentially eroding 30% of market share. To counter this, Shionogi pursues combination therapies and next-generation antibiotics, allocating 15% of revenues to innovation.

Stock performance reflects optimism. Shionogi's shares rose 25% in 2023, partly attributed to Cefiderocol's success, as reported in financial statements. Institutional investors, including those from BlackRock and Vanguard, increased stakes, signaling confidence in its long-term cash flow.

Forecasts incorporate macroeconomic factors. Inflation and currency fluctuations impact export revenues, particularly from the U.S. to Japan. Despite this, Cefiderocol's role in pandemic preparedness programs, like those backed by the World Health Organization, ensures steady demand and government funding.

Challenges and Opportunities

Cefiderocol faces hurdles in adoption, including high costs and stewardship programs that restrict overuse to prevent further resistance. In 2023, U.S. hospitals reported resistance rates above 50% for targeted bacteria, amplifying demand but also scrutiny on pricing.

Opportunities arise from emerging markets. India's growing healthcare sector, with infection rates surging, presents a $100 million potential market by 2025. Shionogi's partnerships with local firms could accelerate entry, leveraging cost-effective manufacturing.

Regulatory evolutions offer another avenue. The FDA's recent fast-track designations for resistant infections expedite approvals, potentially adding $50 million in annual sales. Additionally, collaborations with global health bodies could secure subsidies, enhancing accessibility.

Future Outlook

Looking ahead, Cefiderocol Sulfate Tosylate's trajectory hinges on innovation and market expansion. By 2030, experts predict a 15% compound annual growth rate, fueled by aging populations and urbanization in developing regions. Shionogi plans to integrate AI-driven diagnostics to optimize prescribing, potentially boosting utilization rates by 20%.

Sustainability efforts, such as eco-friendly production, align with global trends, reducing environmental impacts and appealing to ESG-focused investors. This positions Cefiderocol not just as a drug, but as a strategic asset in Shionogi's portfolio, promising robust returns for stakeholders.

Key Takeaways

• Cefiderocol Sulfate Tosylate drives growth in the antibiotics market, with sales projected to reach $500 million by 2028, supported by strong patents and regulatory advantages.
• Market dynamics favor expansion in North America and Europe, though challenges like pricing and supply chain risks require strategic management.
• Financially, the drug enhances Shionogi's profitability, with high margins and investor interest, but generic competition post-2035 demands proactive innovation.
• Opportunities in emerging markets and new indications could add significant revenue, making it a key watch for pharmaceutical investments.
• Overall, Cefiderocol exemplifies how targeted therapies can navigate resistance trends, offering a blueprint for sustainable growth in biotech.

FAQs

1. What makes Cefiderocol Sulfate Tosylate unique compared to other antibiotics?
   It uses a siderophore mechanism to penetrate bacterial cells, effectively treating multi-drug resistant infections that standard antibiotics cannot.

2. How has Cefiderocol impacted Shionogi's financial performance?
   The drug contributed $180 million in sales in 2023, boosting overall revenue and stock value by supporting high-margin growth segments.

3. What regulatory approvals has Cefiderocol received?
   It gained FDA approval in 2019 for urinary tract infections and 2020 for pneumonia, plus EMA authorization in 2020, facilitating global market access.

4. What are the main challenges for Cefiderocol's market growth?
   High pricing and potential supply chain disruptions could limit adoption, especially in cost-sensitive regions like Asia-Pacific.

5. How might patent expiration affect Cefiderocol's future?
   Patents expiring around 2035 may introduce generics, potentially reducing market share by 30%, unless Shionogi develops successor products.

Sources

1. Shionogi & Co., Ltd. Annual Report 2023, detailing sales figures and R&D investments for Cefiderocol.
2. IQVIA Market Research Report 2023, on antibiotics market size and competition analysis.
3. U.S. Food and Drug Administration (FDA) approval documents for Cefiderocol, including QIDP designations.
4. Evaluate Pharma Forecast 2024-2030, providing revenue projections for pharmaceutical drugs.