FETROJA Drug Patent Profile

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

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

This drug has eighty-six 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 November 14, 2029. 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:	86
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:

GENERATING ANTIBIOTIC INCENTIVES NOW

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
Pisa University Hospital	Phase 4
Sheba Medical Center	Phase 4
Monaldi Hospital	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 GENERATING ANTIBIOTIC INCENTIVES NOW.

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	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445-001	Nov 14, 2019		RX	Yes	Yes			Y	Y
Shionogi	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445-001	Nov 14, 2019		RX	Yes	Yes
Shionogi	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445-001	Nov 14, 2019		RX	Yes	Yes			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
Australia	2015312828
Brazil	112017004166
Canada	2959295

Supplementary Protection Certificates for FETROJA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2960244	301067	Netherlands		PRODUCT NAME: CEFIDEROCOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/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	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

FETROJA (cefiderocol) Market Dynamics and Financial Trajectory: Sales Drivers, Pricing Pressure, and Exclusivity-to-Generic Risk

Last updated: July 27, 2026

Fetroja (cefiderocol) is a newer, hospital-focused parenteral antibiotic whose financial trajectory is shaped by (1) stewardship-driven adoption for carbapenem-resistant Enterobacterales (CRE) and other difficult-to-treat serious gram-negative infections, (2) hospital formulary access and switching from older last-resort agents, (3) payer contracting and ASP discipline, and (4) exclusivity and patent-limitation events that influence generic or “authorized” competitive entry timing. The drug’s market outlook remains concentrated in large IDN systems and high-acuity settings, with sales sensitive to outbreak patterns, guideline updates, and competition from other “newer” beta-lactams and last-line agents.

Scope note: This analysis covers market dynamics, commercialization levers, and financial trajectory logic for Fetroja. Patent and Orange Book mapping would be required for a precise exclusivity calendar and generic risk ranking.

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What market dynamics drive FETROJA (cefiderocol) adoption in hospitals?

Fetroja’s demand is driven by hospital inpatient antimicrobial use rather than outpatient prescribing. The antibiotic competes in a constrained, high-need segment where clinicians value reliable coverage for multidrug-resistant gram-negative pathogens and the ability to standardize therapy.

Which infection indications anchor utilization for cefiderocol?

Commercial traction typically follows guideline-adjacent adoption for serious gram-negative infections, especially where resistance breadth matters. Key utilization categories include:

• Carbapenem-resistant Enterobacterales (CRE) infections
• Healthcare-associated and hospital-acquired pneumonia (as labeled, depending on FDA indication scope)
• Complicated urinary tract infections and other serious gram-negative infections where clinicians face limited oral options and high failure costs with older agents
• Cases where clinicians seek a “one-bottle” approach versus combination therapy escalation

How do antimicrobial stewardship and formulary decisions affect sales?

Stewardship approvals often determine who can use cefiderocol and when. Hospital formulary dynamics tend to:

• Favor restricted access (pre-authorization or stewardship review)
• Allocate use to specific resistance phenotypes and severity strata
• Require local antibiogram alignment and internal outcome tracking
• Constrain adoption when alternative restricted agents already cover stewardship protocols

What competitive forces pressure FETROJA pricing and share?

Pricing pressure comes from contracting and therapeutic substitution rather than OTC competition. Competitive pressure typically includes:

• Other parenteral “novel” agents and newer beta-lactam/beta-lactamase inhibitor combinations used for CRE or MDR gram-negative infections
• Agents positioned as carbapenem-sparing options
• Rapid uptake of any competitor with lower acquisition cost per course or better formulary fit

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How has FETROJA performed financially since launch, and what revenue shape should investors expect?

Without a clean, accessible set of audited financial statements or disclosed quarterly sales figures in this context, the most accurate way to map financial trajectory is through revenue-shape drivers: access, penetration, and persistence of use.

What typically happens to sales after antibiotic launch?

Hospital antibiotics like Fetroja usually follow a staged pattern:

1. Early uptake driven by high-need clinical experience and regional ID specialists
2. Middle phase where penetration accelerates through system-wide contracting and IDN purchasing
3. Mature phase where growth becomes a function of replacement cycles, resistance trends, and formulary re-tendering

What metrics indicate whether FETROJA is gaining or losing share?

Key observable commercial indicators include:

• Number of institutions with unrestricted versus restricted formulary status
• Contracted ASP movement relative to peers in CRE/MDR gram-negative categories
• Patient-days of therapy trends in IDNs that report antibiotic utilization
• Share shifts following new guideline publications or competitor launches

What revenue risks matter most to cefiderocol’s financial trajectory?

The dominant revenue risks are:

• Narrow-label or guideline-limited usage that caps addressable demand
• Market cannibalization by lower-cost competitors in restricted therapy pathways
• Hospital budget tightening that shifts utilization toward preferred formulary agents
• Supply constraints or logistics issues, which can temporarily suppress use even with clinical demand

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When does FETROJA lose exclusivity and how does that affect generic entry risk?

No definitive exclusivity and expiration timetable is provided here because a precise Orange Book and patent estate review is required for confident dates and claim coverage. That review must include drug substance, drug product, polymorph/crystal form (if any), process, and method-of-use patents, plus any FDA exclusivity periods tied to supplemental approvals.

What generic entry routes are most relevant for FETROJA?

For a hospital parenteral antibiotic, the relevant competitive pathways are typically:

• Full generic substitution based on ANDA approval with bioequivalence and label sameness
• “Carve-out” label changes that reduce clinical substitution but still permit limited market presence
• Patent challenge litigation that delays approval unless settlements accelerate timelines

How would a patent challenge typically impact commercialization?

• If challengers file Paragraph IV certifications, the timeline becomes settlement-or-approval driven
• Even where exclusivity remains, competitive pressure can arrive via “off-label” therapeutic substitution rather than true generic availability

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What is the Orange Book status of FETROJA and what patents protect cefiderocol?

A correct Orange Book view requires direct listing retrieval. Without that dataset in this context, the exact set of listed patents, their expiration dates, and which are tied to the drug product versus method-of-use cannot be stated without risking inaccuracies.

What patent categories most commonly matter for antibiotics like cefiderocol?

• Composition of matter (API level)
• Formulation/drug product patents (stability, excipients, sterility, reconstitution)
• Method-of-use patents (indications or resistance-phenotype treatment)
• Manufacturing process patents (scale-up, purification)
• Crystal form or polymorph patents, if applicable

How does patent scope translate into market risk?

• Composition-of-matter protection is the strongest constraint on true generic substitution
• Method-of-use protection can delay label-based substitution even if a generic is approved for other indications
• Formulation protection can block product substitution for the same strength and dosage form

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Which companies are likely to compete with FETROJA, and how do their pipelines change uptake dynamics?

Fetroja competes in the last-resort CRE/MDR gram-negative segment where pipeline cadence matters. Competitor outcomes that can alter cefiderocol share include:

• Any drug demonstrating improved outcomes in hard-to-treat MDR settings
• Any drug with superior tolerability allowing broader empiric or step-down strategies
• Any drug that earns formulary preference via contracted pricing

How does a competitor’s labeling affect real-world switching?

Real-world switching usually follows:

• Label alignment with a clinician’s decision point (empiric vs targeted)
• Resistance phenotype match to local antibiograms
• Hospital protocols that specify first-line and second-line “restricted” therapies

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How strong is the patent estate for cefiderocol and what is the practical litigation risk?

A strength assessment requires claim-level detail and litigation docket specifics. Those inputs are not present in this context, so no quantified litigation-risk ranking is provided.

What kinds of patent disputes would matter for future revenue?

• If method-of-use claims dominate, generic entry can occur but with constrained label
• If drug product/formulation claims dominate, branded supply or reconstitution advantages matter for substitution
• If composition-of-matter claims dominate, entry risk is lower until expiration or successful challenges

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What formulation and dosing characteristics influence hospital purchasing and demand?

For IV antibiotics, operational fit influences contracting outcomes.

What aspects matter for procurement and clinician workflow?

• IV administration convenience, infusion time, and compatibility considerations
• Storage stability and pharmacy handling
• Rate of reconstitution and readiness for stewardship protocols
• Hospital stock management and wastage risk

How do these attributes affect share vs competitors?

Even with equivalent clinical efficacy, procurement often selects the easiest drug to implement at scale across inpatient wards and ICUs.

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What generic entry risks exist for FETROJA by geography (US, EU, UK) and pathway (ANDA, national procedures)?

A geography-by-geography risk map requires:

• EU marketing authorization status and patent linkage landscape
• UK SPC and patent linkage status
• US Orange Book listing and patent expiration dates
• Any national marketing authorization of generics or biosimilar-like analogs (for biologics, which does not apply here)

Those data are not included in this context, so no geographic risk matrix is provided.

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Key Takeaways

• Fetroja’s market is structurally constrained to inpatient, high-acuity and stewardship-guided use for serious MDR gram-negative infections.
• Financial trajectory is most sensitive to hospital formulary adoption, contracted ASP positioning versus peers, and persistence of clinical demand in CRE/MDR scenarios.
• Pricing pressure is driven primarily by contracting and therapeutic substitution, not by retail competition.
• Generic and competitive risk depends on the Fetroja patent estate and FDA/RD exclusivity schedule; those details require Orange Book and patent-list retrieval to state dates and entry scenarios correctly.

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FAQs

1) Is FETROJA primarily used for CRE infections or broader gram-negative coverage?

It is used for serious gram-negative infections where resistance breadth and clinical severity drive last-resort antibiotic selection, with CRE and other hard-to-treat presentations typically acting as key utilization anchors.

2) What drives formulary adoption of cefiderocol in integrated delivery networks?

Contracting terms, stewardship protocol fit, clinical pathway alignment, and operational handling (IV pharmacy workflow) are the main determinants.

3) Does FETROJA face pricing pressure from alternative last-line antibiotics?

Yes. Even without generic competition, hospitals can shift restricted use toward lower-cost preferred agents, creating ASP and volume pressure.

4) How can guideline changes affect FETROJA demand?

Guidelines that expand or narrow recommended use for MDR gram-negative infections shift eligible cases for restricted therapies and can change prescribing thresholds.

5) What is the biggest risk to FETROJA’s long-term revenue growth?

Loss of restricted formulary share due to competitor substitution and any delay in achieving system-wide penetration during successive contract renewals.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval Package: Fetroja (cefiderocol). U.S. Food and Drug Administration.