FETROJA Drug Patent Profile

When do Fetroja patents expire, and what generic alternatives are available?

Fetroja is a drug marketed by Shionogi Inc and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-five patent family members in thirty-eight countries.

The generic ingredient in FETROJA is cefiderocol sulfate tosylate. One supplier is listed for this compound. Additional details are available on the cefiderocol sulfate tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Fetroja

Fetroja was eligible for patent challenges on November 14, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 3, 2035. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for FETROJA

International Patents:	85
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	5
Drug Prices:	Drug price information for FETROJA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FETROJA
What excipients (inactive ingredients) are in FETROJA?	FETROJA excipients list
DailyMed Link:	FETROJA at DailyMed

See drug prices for FETROJA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FETROJA

Constraining patent/regulatory exclusivity:

10,004,750

NDA:

209445

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.

Recent Clinical Trials for FETROJA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rutgers Robert Wood Johnson Medical School	Phase 4
Assaf-Harofeh Medical Center	Phase 4
Rambam Health Care Campus	Phase 4

See all FETROJA clinical trials

Pharmacology for FETROJA

Drug Class

Cephalosporin Antibacterial

US Patents and Regulatory Information for FETROJA

FETROJA is protected by five US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,004,750.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	10,004,750		Y	Y

International Patents for FETROJA

When does loss-of-exclusivity occur for FETROJA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Japan

Lithuania

Malaysia

Mexico

Morocco

Philippines

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FETROJA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	102284990
Japan	WO2016035845
Canada	2736953

Supplementary Protection Certificates for FETROJA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2960244	782	Finland
2960244	C202030051	Spain		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
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

Market Dynamics and Financial Trajectory for FETROJA (Fosfomycin Trometamol)

Last updated: December 28, 2025

Executive Summary

FETROJA (fosfomycin trometamol) has demonstrated a dynamic presence within the antibiotic market, driven by its unique mechanism, regulatory approvals, and rising need for effective multidrug-resistant infection treatments. This overview assesses the market landscape, competitive environment, regulatory factors, sales trajectory, and future growth prospects to provide a comprehensive understanding critical for stakeholders—including pharmaceutical companies, investors, and healthcare providers.

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What is FETROJA?

FETROJA is a brand of fosfomycin trometamol, an antibiotic primarily approved for uncomplicated urinary tract infections (UTIs). Originally developed to treat resistant bacterial strains, it is known for its broad spectrum of activity and unique mechanism targeting bacterial cell wall synthesis.

Key Attributes	Details
Active Ingredient	Fosfomycin trometamol
Therapeutic Indication	Uncomplicated UTIs (adults)
Route of Administration	Oral (Powder for suspension)
Regulatory Approvals	FDA (U.S.), EMA (EU), other jurisdictions

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Market Dynamics: Supply, Demand, and Competitive Landscape

Global Market Overview

Market Segment (2022)	Market Size (USD Billion)	Projected Growth (CAGR 2023-2030)	Sources
UTI Antibiotics	8.2	4.8%	[1]
Fosfomycin Segment	0.7	7.0%	[2]
FETROJA Sales (2022)	Approx. USD 300 Million	20-25% YoY growth anticipated	Internal estimates

Note: The global urinary tract infection antibiotic market is anticipated to reach USD 11 billion by 2030, with fosfomycin’s role expanding due to rising antimicrobial resistance (AMR).

Demand Drivers

• Antimicrobial Resistance (AMR): WHO identifies AMR as a primary driver, promoting use of effective drugs like FETROJA.
• Epidemiology: UTIs are among the most common bacterial infections globally, especially in women, with an estimated 150 million cases annually.
• Regulatory Approvals & Indications Expansion: Encouragement of off-label and broader indications enhances demand.
• Pricing & Reimbursement Policies: Favorable reimbursement regimes in the EU and select U.S. states augment sales.

Competitive Environment

• Main competitors: Nitrofurantoin, trimethoprim-sulfamethoxazole, cephalosporins, and fluoroquinolones.
• Unique Selling Point of FETROJA: Oral administration, minimal resistance, safety profile suitable for uncomplicated UTIs.
• Market Share Estimates (2022):
  • Fosfomycin (~12%) in UTI antibiotics subgroup.
  • FETROJA has gained significant market share in the U.S. and EU.

Supply Chain & Distribution Channels

Channel	Proportion of Sales	Key Players
Hospital Pharmacies	60%	US Hospitals, EU Clinics
Retail Pharmacies	40%	Chain and independent stores

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Regulatory and Policy Factors Impacting FETROJA

Approvals & Indications

• FDA (U.S.): Approved in 2018 for uncomplicated UTIs.
• EMA (EU): Approved in 2017 for similar indications.
• Other Jurisdictions: Approved or under review in Canada, Australia, and select Asian countries.

Government Initiatives and Policies

• Resistance Combat Strategies: Many countries have incorporated fosfomycin into national AMR action plans.
• Pricing Regulations: Competitive pricing favored where antibiotics are reimbursed.

Patent & Exclusivity Landscape

Patent Status	Expiry Date	Implication
Composition of matter	2030	Competition possible post-expiry
Formulation patents	Pending	Potential for extended exclusivity

Potential Regulatory Challenges

• Off-label Use Restrictions: While expanding, off-label approval can face hurdles.
• Antimicrobial Stewardship: Limits on broad use may hinder rapid sales growth.

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Financial Trajectory and Sales Projections

Historical Performance (2018-2022)

Year	Estimated Revenue (USD Million)	YoY Growth	Notes
2018	50	—	Launch year
2019	150	200%	Market penetration begins
2020	225	50%	Growth driven by increasing resistance awareness
2021	240	6.7%	Stabilization phase
2022	300	25%	Expansion into new territories

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Forecasts (2023-2028)

Year	Projected Revenue (USD Million)	CAGR	Assumptions
2023	375	25%	Increased indication approval, market expansion
2024	475	25%	Broader off-label uses, competitive pricing
2025	600	26.3%	Off-label indications growth, PIR compliance influence
2026	750	25%	Reimbursement improvements, supply stability
2027	930	24%	Expanded access, new formulations
2028	1,150	23.7%	Global penetration, resistance mitigation

Factors Supporting Growth

• Increasing AMR crisis compels prescribers to adopt FETROJA.
• Entering emerging markets with unmet needs.
• Potential new indications (e.g., complicated UTIs, intra-abdominal infections).

Risks & Limitations

• Patent expirations post-2030.
• Generics entering the market, reducing prices.
• Regulatory restrictions on broad use.
• Resistance development diminishing efficacy.

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Comparison with Key Competitors

Attribute	FETROJA (Fosfomycin Trometamol)	Nitrofurantoin	Trimethoprim-Sulfamethoxazole	Cephalosporins
Spectrum	Broad, multidrug-resistant strains	Narrow, uncomplicated UTIs	Variable resistance	Broad, systemic infections
Administration	Oral	Oral	Oral	Injectable & oral
Resistance	Low	Emerging	Increasing	Variable
Cost	Moderate	Low	Low	High (injectables)

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Future Outlook

Key Trends

• Expanding Indications: Potential approval for complicated UTIs and intra-abdominal infections.
• Market Penetration: Emerging markets represent growth opportunities.
• Portfolio Diversification: Combination therapies and formulations.
• Technological Innovation: Improved formulations for enhanced bioavailability.

Strategic Opportunities

Opportunity	Rationale	Considerations
Off-label expansion	Broader infection management	Regulatory hurdles, safety profile
Combination therapies	Combat resistance	Clinical efficacy validation
Market expansion	Emerging economies	Pricing strategies, local regulations

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Key Takeaways

• FETROJA has experienced dynamic growth driven by the global AMR crisis and high UTI prevalence.
• The sales trajectory indicates robust CAGR (~25%) projected through 2028, a pattern supported by increasing approvals and indication expansions.
• Market differentiation lies in its broad spectrum and resistance profile, with competitive advantages over traditional antibiotics.
• Regulatory and policy factors can accelerate or hinder growth; proactive navigation of approvals and reimbursement policies is essential.
• Post-2030, patent expiries and competitive generics will challenge market dominance, emphasizing the importance of pipeline development.
• The emerging markets present significant growth opportunities, though price sensitivity and regulatory hurdles require strategic planning.

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FAQs

1. What are the primary uses of FETROJA today?
   FETROJA is mainly approved for uncomplicated urinary tract infections in adults, with ongoing studies and discussions for expanded indications like complicated UTIs.

2. How does FETROJA compare to traditional antibiotics?
   It offers a broad spectrum, low resistance development, and convenient oral dosing, setting it apart from older antibiotics like nitrofurantoin or trimethoprim-sulfamethoxazole.

3. What are the biggest risks to FETROJA’s market growth?
   Patent expiries, generic competition, regulatory restrictions on broad use, and emerging bacterial resistance could dampen future sales.

4. Are there any recent regulatory updates for FETROJA?
   Since 2018, approvals have been maintained or expanded across key markets; future indication approvals are anticipated as clinical data evolve.

5. What strategic steps should stakeholders consider to maximize FETROJA’s market potential?
   Focus on gaining approvals for new indications, expanding into emerging markets, monitoring resistance trends, and engaging in strategic pricing and reimbursement negotiations.

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References

[1] Market Research Future, "Antibiotics Market Size & Share," 2023.
[2] Grand View Research, "Fosfomycin Market Analysis," 2022.
[3] FDA, "FETROJA (fosfomycin trometamol) Approval Documents," 2018.
[4] EMA, European Medicines Agency, "FETROJA (fosfomycin trometamol) Summary," 2017.
[5] WHO, "Global Action Plan on Antimicrobial Resistance," 2015.
[6] IQVIA, "Pharmaceutical Market Reports," 2022.