Cefiderocol sulfate tosylate - Generic Drug Details

What are the generic drug sources for cefiderocol sulfate tosylate and what is the scope of freedom to operate?

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-five patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for cefiderocol sulfate tosylate

International Patents:	85
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cefiderocol sulfate tosylate
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

Constraining patent/regulatory exclusivity:

10,004,750

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	9,238,657		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	9,949,982		Y

International Patents for cefiderocol sulfate tosylate

Country	Patent Number	Title	Estimated Expiration
Spain	2564836
European Patent Office	3190115
Eurasian Patent Organization	201170632

Supplementary Protection Certificates for cefiderocol sulfate tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2960244	C20200033 00355	Estonia		PRODUCT NAME: TSEFIDEROKOOL;REG NO/DATE: EU/1/20/1434 24.04.2020
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	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

Last updated: July 28, 2025

rket Dynamics and Financial Trajectory for Cefiderocol Sulfate Tosylate

Introduction
Cefiderocol sulfate tosylate, a novel siderophore cephalosporin antibiotic, has gained prominence amid the rising threat of multidrug-resistant Gram-negative bacteria. Market dynamics surrounding this drug are influenced by an array of factors including clinical efficacy, antimicrobial resistance patterns, regulatory landscape, and competitive positioning. This article provides a comprehensive analysis of the financial trajectory and market environment for cefiderocol sulfate tosylate, offering valuable insights for stakeholders aiming to capitalize on this innovative antibiotic.

Therapeutic Profile and Clinical Positioning
Cefiderocol’s unique mechanism leverages siderophore-mediated iron transport pathways to penetrate bacterial cell walls, effectively targeting carbapenem-resistant pathogens such as Pseudomonas aeruginosa, Acinetobacter baumannii, and Enterobacterales. Approved by the U.S. Food and Drug Administration (FDA) in 2019 and the European Medicines Agency (EMA) in 2020, cefiderocol is positioned as a last-resort treatment for serious infections, including complicated urinary tract infections, hospital-acquired pneumonia, and bloodstream infections. Its efficacy in overcoming multidrug resistance (MDR) has rendered it critical amidst the escalating global antimicrobial resistance crisis.

Market Drivers

1. Rising Antimicrobial Resistance (AMR)
   According to the Centers for Disease Control and Prevention (CDC), at least 2.8 million antibiotic-resistant infections occur annually in the U.S. alone, leading to over 35,000 deaths. The proliferation of carbapenem-resistant organisms has created an urgent need for effective therapies like cefiderocol, bolstering its market demand. As resistance trends escalate, cefiderocol’s role as a potent agent against MDR pathogens becomes increasingly vital, driving sales and adoption.

2. Regulatory Approvals and Off-Label Use
   The drug’s regulatory approval in major markets like the U.S. and Europe has facilitated its clinical adoption. Additionally, clinicians are exploring off-label indications based on emerging clinical data, expanding its therapeutic scope. This trend potentially amplifies demand, although off-label usage remains subject to varying regulatory and insurance considerations.

3. Limited Competition
   While several beta-lactam/beta-lactamase inhibitor combinations threaten to encroach on the market, cefiderocol’s distinctive siderophore delivery system affords it a competitive edge against resistant organisms. Nonetheless, pipeline drugs under development could influence future market shares, necessitating ongoing strategic positioning.

4. Pricing Strategies and Reimbursement Landscape
   Cefiderocol’s high manufacturing costs necessitate premium pricing strategies. Reimbursability by national healthcare systems and insurance providers is critical; favorable reimbursement frameworks amplify market penetration. However, pricing pressures from antimicrobial stewardship programs and cost-containment policies pose challenges for profitability.

Market Challenges

• Clinical Data Limitations
  While efficacy data is robust, some clinical trials, notably the CREDIBLE-CR study, revealed higher mortality rates in certain subgroups, raising concerns among prescribers and regulators. Ongoing post-marketing surveillance and further real-world evidence are essential to solidify confidence and expand indications.

• Resistance Development
  Though cefiderocol is designed to circumvent common resistance mechanisms, emerging reports of resistance, including mutations affecting iron transport pathways, threaten long-term efficacy. Continuous surveillance and combination therapy strategies are necessary to mitigate this risk.

• Pricing and Access Barriers
  Premium pricing restricts use to hospitalized patients and severe cases, limiting broader access. Reimbursement constraints and stewardship policies may restrict prescribing, impacting revenue potential.

Financial Trajectory and Market Forecasts

The global antibiotic market was valued at approximately USD 49.2 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 3.4% through 2028[1]. Cefiderocol, as one of the key innovations targeting resistant pathogens, is expected to secure a significant share within this niche, especially post its inclusion in hospitals' formularies.

Revenue Projections
Market analysts forecast cefiderocol’s global sales to reach USD 300-400 million annually by 2025, assuming steady adoption in the intensive care setting and expanding indications. Factors influencing this trajectory include:

• Geographic Expansion
  Initial sales are concentrated in North America and Europe, with Asia-Pacific emerging as a promising market due to high MDR prevalence and increasing healthcare infrastructure investments. Regulatory approvals in additional countries will further accelerate revenue growth.

• Healthcare System Adoption
  Hospital formularies increasingly favor new agents like cefiderocol, especially for MDR infections. Adoption rates are expected to increase with the accumulation of positive clinical outcomes and health economic evidence.

• Manufacturing and Supply Chain Dynamics
  Efficient production collaborations, such as those by Shionogi (the developer), are crucial to meet demand and manage costs. Scalability and stability of supply chains will directly impact competitiveness and profitability.

Investment Perspective
Pharmaceutical companies and investors have shown keen interest in antimicrobial assets aligned with global health needs. Cefiderocol’s positioning as a pioneer in siderophore antibiotics offers growth potential, especially if resistance patterns remain favorable. Strategic partnerships with healthcare providers and regulatory bodies will be instrumental in expanding its market footprint.

Competitive Landscape and Strategic Outlook

Cefiderocol’s primary competitors include newer beta-lactam/beta-lactamase inhibitor combinations such as meropenem-vaborbactam and imipenem-relebactam. However, their efficacy against specific resistant pathogens varies, positioning cefiderocol uniquely in the resistant Gram-negative space.

Future Market Trends

• Pipeline Developments: Emergence of combination therapies and next-generation siderophore antibiotics could redefine competition dynamics.

• Global Health Initiatives: Governments and organizations like the WHO are prioritizing antimicrobial stewardship and incentives for novel antibiotics, potentially influencing market access and funding.

• Economic Incentives: Push for innovation through public-private collaborations and grants could lower development costs, improving profitability prospects.

Key Takeaways

• Cefiderocol sulfate tosylate addresses a critical unmet need in combating MDR Gram-negative infections, underpinning its robust market demand.
• Its unique siderophore delivery mechanism confers strategic advantages, though emerging resistance and clinical data nuances necessitate ongoing vigilance.
• Favorable regulatory approvals and hospital formulary placements will drive revenue, projected to reach USD 300-400 million globally by 2025.
• Market growth will be shaped by geographic expansion, reimbursement policies, and competitive innovations.
• Investors and pharma stakeholders should monitor resistance trends, clinical outcomes, and pipeline developments to inform strategic decisions.

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FAQs

1. What distinguishes cefiderocol sulfate tosylate from other antibiotics targeting resistant bacteria?
   Cefiderocol features a siderophore-based mechanism that exploits bacterial iron uptake pathways, allowing it to effectively penetrate and kill carbapenem-resistant Gram-negative bacteria, providing an advantage over conventional beta-lactams.

2. What are the main factors influencing cefiderocol’s market adoption?
   Clinical efficacy against MDR pathogens, regulatory approvals, hospital formulary inclusion, reimbursement policies, and emerging resistance patterns significantly influence its market penetration.

3. Is cefiderocol likely to face resistance challenges in the future?
   While designed to overcome common resistance mechanisms, reports of emerging resistance suggest ongoing surveillance is vital. Strategic use and stewardship programs are essential to prolong its effectiveness.

4. How does the pricing of cefiderocol impact its market potential?
   High manufacturing and R&D costs necessitate premium pricing, which may limit use to severe cases under hospital settings. Reimbursement frameworks and stewardship policies could further influence utilization.

5. What is the long-term outlook for cefiderocol in the global antimicrobial market?
   With increasing resistant infections worldwide, cefiderocol’s niche position and clinical advantages suggest sustained demand. Future expansion depends on clinical data, resistance trends, pipeline competition, and health policy support.

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References
[1] MarketWatch. “Antibiotics Market Size, Share & Trends Report,” 2022.