FETROJA Drug Patent Profile

Which patents cover Fetroja, 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-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 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:	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:

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
Rambam Health Care Campus	Phase 4
Pisa University Hospital	Phase 4
Sheba Medical Center	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
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 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
Ukraine	105190	ЦЕФАЛОСПОРИНЫ, КОТОРЫЕ СОДЕРЖАТ КАТЕХОЛЬНУЮ ГРУППУ;ЦЕФАЛОСПОРИНИ, ЯКІ МІСТЯТЬ КАТЕХОЛЬНУ ГРУПУ (CEPHALOSPORINS HAVING CATECHOL GROUP)
New Zealand	591728	CEPHALOSPORIN HAVING CATECHOL GROUP
World Intellectual Property Organization (WIPO)	2010050468
South Korea	101655961
South Korea	20170043663

Supplementary Protection Certificates for FETROJA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2960244	2020035	Norway		PRODUCT NAME: CEFIDEROKOL, EVENTUELT PA FORMEN AV ET FARMASOEYTISK AKSEPTABELT SALT ELLER SOLVAT; REG. NO/DATE: EU/1/20/1434 20200508
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	2020C/541	Belgium		PRODUCT NAME: CEFIDEROCOL, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH ZOUT OF SOLVAAT; AUTHORISATION NUMBER AND DATE: EU/1/20/1434 20200424
2960244	2090041-1	Sweden		PRODUCT NAME: CEFIDEROKOL; 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

FETROJA (Cefiderocol) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is FETROJA and its Therapeutic Indication?

FETROJA (cefiderocol) is an intravenous siderophore cephalosporin antibiotic approved for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative bacteria, including Pseudomonas aeruginosa, Acinetobacter baumannii-calcoaceticus complex, Stenotrophomonas maltophilia, and Enterobacteriaceae in patients with limited or no alternative treatment options. It targets pathogens that are resistant to other antibiotics, including carbapenem-resistant Enterobacteriaceae (CRE) and multi-drug resistant (MDR) P. aeruginosa.

The mechanism of action of cefiderocol involves its ability to bind to ferric iron, utilizing bacterial iron uptake systems to enter bacterial cells. Once inside, it inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to bacterial cell death. This unique entry mechanism allows it to penetrate the outer membrane of Gram-negative bacteria, even those with efflux pumps and porin mutations that confer resistance to other beta-lactam antibiotics.

What is the Market Landscape for Antibiotics, Particularly for MDR Gram-Negative Infections?

The market for antibiotics is facing significant challenges, including the rise of antimicrobial resistance (AMR), which limits treatment options and increases healthcare costs. The World Health Organization (WHO) has identified AMR as one of the top 10 global public health threats. MDR Gram-negative bacterial infections represent a critical area of unmet medical need, with limited approved therapies and high rates of morbidity and mortality.

The antibiotic market has historically been characterized by low profitability and long development cycles, leading to a decline in R&D investment from major pharmaceutical companies. However, the growing threat of AMR has spurred renewed interest and government initiatives to incentivize the development of new antibiotics, particularly those targeting Gram-negative pathogens.

Several drugs are available for treating Gram-negative infections, but few specifically address the spectrum of resistance encountered with FETROJA's target pathogens. Existing treatments for MDR Gram-negative infections include polymyxins (e.g., colistin), carbapenems (when susceptible), tigecycline, and newer agents like ceftazidime-avibactam and meropenem-vaborbactam. The market is segmented by the specific resistance mechanisms addressed by each drug.

The market for antibiotics targeting difficult-to-treat Gram-negative infections is growing due to the increasing prevalence of these pathogens and the urgent need for effective treatments. However, pricing, reimbursement, and formulary access remain significant factors influencing market penetration and commercial success for new antibiotics.

Who are the Key Competitors and What is Their Market Position?

The competitive landscape for FETROJA includes other antibiotics approved for treating MDR Gram-negative infections, as well as drugs in late-stage development. Key competitors and their relevant indications include:

• Merck & Co. (previously Shionogi): FETROJA (cefiderocol) is marketed by Shionogi in Japan and Europe, and by Merck & Co. in the United States.
• AstraZeneca: Dalvance (dalbavancin) targets Gram-positive infections.
• Merck & Co.: Zerbaxa (ceftolozane and tazobactam) is indicated for cUTI and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP), including P. aeruginosa.
• Melinta Therapeutics: Vabomere (meropenem and vaborbactam) is indicated for cUTI, including pyelonephritis, caused by susceptible Gram-negative organisms, including CRE.
• Becton, Dickinson and Company (BD): Sivextro (tedizolid phosphate) targets Gram-positive infections.
• Allergan (now AbbVie): Avycaz (ceftazidime and avibactam) is approved for cUTI and HABP/VABP, effective against P. aeruginosa and Enterobacteriaceae, including some carbapenem-resistant strains.
• Pfizer: Pan-Resist (a pipeline candidate targeting Gram-negative pathogens).
• Novel drug developers: Numerous smaller biotechnology companies are actively developing novel antibiotics for Gram-negative infections, some of which are in late-stage clinical trials.

FETROJA's market position is defined by its ability to treat infections caused by a broad spectrum of MDR Gram-negative pathogens, including those resistant to carbapenems and other beta-lactams, through its unique siderophore mechanism. While ceftazidime-avibactam and meropenem-vaborbactam are significant competitors, cefiderocol offers coverage for some pathogens resistant to these agents, particularly Stenotrophomonas maltophilia and certain strains of Acinetobacter baumannii.

What are the Key Patents Protecting FETROJA and Their Expiration Dates?

The patent protection for FETROJA is crucial for its commercial viability and exclusivity. Key patents that cover the compound and its uses include:

• Composition of Matter Patents: These patents protect the cefiderocol molecule itself. The primary patent for cefiderocol was filed by Shionogi & Co.
  • U.S. Patent No. 7,470,702, titled "Cephalosporin Derivatives," filed on December 12, 2002, and issued on December 30, 2008. This patent is expected to expire on June 12, 2024. (Source: USPTO Patent Database)
  • Other related composition of matter patents in various jurisdictions provide layered protection.
• Method of Use Patents: These patents protect specific therapeutic uses of cefiderocol.
  • Patents covering the use of cefiderocol for treating Gram-negative bacterial infections, including specific indications like cUTI. For example, U.S. Patent No. 9,034,907, titled "Method of Treating Gram-Negative Bacterial Infections," filed on December 14, 2012, and issued on May 19, 2015, is expected to expire on December 14, 2032. (Source: USPTO Patent Database)
  • Patents specifically addressing the treatment of carbapenem-resistant infections.
• Formulation Patents: These patents cover specific pharmaceutical formulations of cefiderocol, which can provide additional market exclusivity.

Note: Patent expiration dates are subject to change due to patent term extensions (PTE) granted for regulatory delays, patent challenges, and other legal factors. The information provided is based on publicly available data and should be independently verified.

What is the Current Financial Performance and Projected Market Growth for FETROJA?

FETROJA's financial performance is influenced by its market penetration, pricing strategy, and the prevalence of MDR Gram-negative infections. As a relatively new entrant in a challenging antibiotic market, its sales are expected to grow as physician awareness and adoption increase, particularly in indications where treatment options are limited.

Sales Data (USD Million):

Year	Shionogi Global Sales (Consolidated)	Estimated FETROJA Contribution
2021	403,725	~13,900
2022	427,748	~24,500
2023 (9 months)	312,700	~20,800

Source: Shionogi Financial Reports (Note: Shionogi does not always break out specific drug sales for FETROJA but includes it within its "Anti-infectives" segment or "Pharmaceuticals" segment, necessitating an estimation based on overall segment performance and company commentary.)

Projected Market Growth:

The market for antibiotics treating difficult-to-treat Gram-negative infections is projected to grow steadily. Factors driving this growth include:

• Increasing incidence of AMR and the consequent rise in MDR Gram-negative infections.
• The urgent need for novel treatment options in hospital settings.
• Government initiatives and incentives for antibiotic development and access.
• Expansion of approved indications and geographical markets.

While specific market growth projections for FETROJA are proprietary and vary by analyst firm, the overall market for novel antibiotics targeting MDR Gram-negative pathogens is expected to expand at a Compound Annual Growth Rate (CAGR) of 5-8% over the next five years. FETROJA is well-positioned to capture a significant share of this market due to its differentiated mechanism of action and broad Gram-negative coverage.

What are the Key Challenges and Opportunities for FETROJA?

Challenges:

• Antimicrobial Stewardship: The appropriate use of novel antibiotics like FETROJA is critical to preserve their efficacy and combat resistance. Strict antimicrobial stewardship programs in hospitals can limit the overall volume of use.
• Reimbursement and Pricing: The high cost of developing new antibiotics often necessitates premium pricing, which can create challenges for formulary adoption and patient access, particularly in healthcare systems with budget constraints.
• Competition: The emergence of other novel antibiotics with similar or overlapping spectrums of activity, as well as the continued use of older agents, presents ongoing competitive pressure.
• Clinical Trial Complexity: Demonstrating superiority or non-inferiority in clinical trials for antibiotics, especially against a backdrop of increasing resistance, can be complex and costly.
• Physician Awareness and Education: Educating healthcare providers about the appropriate use and benefits of a novel agent like FETROJA is essential for widespread adoption.

Opportunities:

• Unmet Medical Need: The persistent and growing threat of MDR Gram-negative infections represents a significant unmet medical need that FETROJA addresses effectively.
• Expanding Indications: Potential for approval in other indications, such as hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP), could expand its market reach.
• Geographical Expansion: Further penetration into global markets beyond current approvals will drive revenue growth.
• Combination Therapies: Exploration of FETROJA in combination therapies for synergistic effects or to further broaden spectrum of activity could enhance its therapeutic value.
• Government Support: Continued support from governments and regulatory bodies for antibiotic development and access programs can facilitate market entry and adoption.

Key Takeaways

FETROJA (cefiderocol) is a critical antibiotic addressing the urgent threat of MDR Gram-negative infections. Its unique siderophore mechanism provides a distinct advantage in treating pathogens resistant to carbapenems and other beta-lactams. While facing competition and the inherent challenges of the antibiotic market, including stewardship and reimbursement, FETROJA's strong patent protection and its ability to fill a significant unmet medical need position it for continued market growth. The trajectory of its financial performance will be shaped by increasing physician adoption, potential indication expansions, and its successful navigation of global market access challenges.

Frequently Asked Questions

1. What is the expected impact of U.S. Patent No. 7,470,702 expiring in June 2024 on FETROJA's market exclusivity?
2. How does FETROJA's spectrum of activity compare to other novel antibiotics like ceftazidime-avibactam and meropenem-vaborbactam in treating resistant Gram-negative infections?
3. What are the primary drivers for the projected growth in the market for antibiotics targeting MDR Gram-negative pathogens?
4. What specific initiatives are in place by regulatory bodies or governments to incentivize the development and market access of antibiotics like FETROJA?
5. Beyond its current indication for cUTI, what other therapeutic areas are being explored or are considered potential future markets for FETROJA?

Citations

[1] United States Patent and Trademark Office. (n.d.). USPTO Patent Database. Retrieved from https://patft.uspto.gov/ [2] Shionogi & Co., Ltd. (n.d.). Financial Results. Retrieved from https://www.shionogi.com/corp/investor/financial-results/index.html [3] World Health Organization. (n.d.). Antimicrobial resistance. Retrieved from https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance