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-three 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.

Indicators of Generic Entry

Summary for FETROJA

International Patents:	83
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
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
Japan	WO2010050468	カテコール基を有するセファロスポリン類
Poland	3190115
World Intellectual Property Organization (WIPO)	2016035845

Supplementary Protection Certificates for FETROJA

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	2090041-1	Sweden		PRODUCT NAME: CEFIDEROKOL; 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

Market Dynamics and Financial Trajectory for Fetroja (Cefiderocol)

Introduction

Fetroja, known generically as cefiderocol, is a groundbreaking antibiotic developed by Shionogi & Co., Ltd. It is designed to combat multidrug-resistant Gram-negative bacterial infections, a growing global health concern. Here, we delve into the market dynamics and financial trajectory of this critical drug.

Regulatory Approvals and Indications

Fetroja has received significant regulatory approvals that have expanded its market reach. In the United States, it was initially approved in November 2019 for treating complicated urinary tract infections (cUTIs) caused by susceptible Gram-negative microorganisms in adults with limited or no alternative treatment options. Later, in September 2020, the FDA granted expanded approval for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adults 18 years and older[1].

In Europe, Fetroja is marketed under the name Fetcroja and is approved for treating infections caused by aerobic Gram-negative organisms in adults with limited treatment options[4].

Clinical Efficacy and Real-World Evidence

The efficacy of Fetroja has been demonstrated through various clinical studies and real-world evidence. The APEKS-NP study showed that Fetroja was comparable to Merrem (meropenem) in terms of all-cause mortality for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia[1].

Real-world evidence presented at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in 2023 highlighted Fetroja's effectiveness against difficult-to-treat Gram-negative bacterial infections, such as those caused by Pseudomonas aeruginosa and Acinetobacter baumannii. The drug achieved clinical cure rates of 65% and 60%, respectively, in severely ill patients with comorbidities[4].

Market Expansion and Global Access

Shionogi has been actively expanding the global reach of Fetroja. The drug is now available in over 135 countries through partnerships with organizations like the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI)[3].

In addition to its presence in the U.S. and Europe, Fetroja has also been approved and is being sold in Japan. Shionogi has signed sales agreements with companies like Sobi for Central and Eastern Europe, further broadening its market[3].

Financial Performance

The financial performance of Fetroja has been robust, contributing significantly to Shionogi's revenue and profitability.

Revenue Growth

In the fiscal year 2023, Fetroja sales saw a notable increase, with the drug contributing to Shionogi's record-high revenue and operating profit. The company reported a significant year-over-year growth in revenue, partly driven by the strong sales of Fetroja and other key products[3].

Geographic Contributions

Fetroja's sales have been strong in both the U.S. and European markets. In the first quarter of fiscal 2024, Shionogi reported substantial revenue from its overseas subsidiaries, including those in the U.S. and Europe, where Fetroja is a key contributor[2].

Pipeline and Future Prospects

Shionogi's pipeline is robust, with a focus on infectious diseases and other therapeutic areas. The company's Medium-Term Business Plan STS2030 outlines ambitious growth targets, including the expansion of Fetroja's global sales. The plan also highlights the importance of addressing the HIV product patent cliff and leveraging new business opportunities, which could further bolster the company's financial performance[3].

Challenges and Considerations

While Fetroja has shown promising results, there are challenges to consider:

Antimicrobial Resistance (AMR)

The global issue of AMR continues to drive the demand for effective antibiotics like Fetroja. However, it also poses a long-term challenge as bacteria evolve to become resistant to existing treatments. Shionogi is actively working to improve global access to Fetroja and to address AMR through collaborations with global health organizations[3].

Clinical Outcomes and Mortality Rates

Some studies have noted an increase in all-cause mortality in patients treated with Fetroja compared to best available therapy (BAT) in certain contexts. This highlights the need for ongoing clinical research and monitoring to optimize treatment outcomes[4].

Financial Statistics and Projections

Here are some key financial statistics and projections related to Fetroja:

• Revenue: In FY2023, Fetroja contributed significantly to Shionogi's revenue, which reached ¥435.1 billion. The company expects continued growth, driven by the global sales of Fetroja and other products[3].
• Operating Profit: Shionogi's operating profit margin was 35.2% in FY2023, with Fetroja being a major contributor to this profitability[3].
• Global Sales Expansion: By 2031, Shionogi aims to establish a strong global sales system, which includes expanding Fetroja's reach in Asia, the U.S., and Europe[3].

Key Takeaways

• Fetroja has received critical regulatory approvals for treating multidrug-resistant Gram-negative bacterial infections.
• The drug has demonstrated strong clinical efficacy and real-world effectiveness.
• Shionogi is actively expanding Fetroja's global reach through strategic partnerships and sales agreements.
• Fetroja has contributed significantly to Shionogi's revenue and profitability.
• The company faces ongoing challenges related to AMR and clinical outcomes.

FAQs

What is Fetroja used for?

Fetroja (cefiderocol) is used to treat hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complicated urinary tract infections caused by susceptible Gram-negative microorganisms in adults.

What are the key regulatory approvals for Fetroja?

Fetroja has been approved by the FDA in the U.S. for treating hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complicated urinary tract infections. In Europe, it is approved under the name Fetcroja for treating infections caused by aerobic Gram-negative organisms.

How effective is Fetroja in real-world settings?

Real-world evidence has shown that Fetroja achieves clinical cure rates of 65% and 60% against Pseudomonas aeruginosa and Acinetobacter baumannii, respectively, in severely ill patients.

What is Shionogi's strategy for expanding Fetroja's global reach?

Shionogi is expanding Fetroja's global reach through partnerships with GARDP and CHAI, and by signing sales agreements with companies like Sobi for Central and Eastern Europe.

What are the financial implications of Fetroja for Shionogi?

Fetroja has significantly contributed to Shionogi's revenue and operating profit, helping the company achieve record-high financial performance in recent years.

What challenges does Fetroja face in the market?

Fetroja faces challenges related to antimicrobial resistance and some clinical outcomes showing increased mortality rates compared to other treatments.

Sources

1. S&P Global Market Intelligence: "Shionogi's antibiotic Fetroja gets expanded US approval to treat pneumonia"[1].
2. Shionogi Inc.: "1st Quarter of Fiscal 2024 Financial Results"[2].
3. Shionogi Inc.: "SHIONOGI Value Journey"[3].
4. BioSpace: "ECCMID 2023: Shionogi Announces Real-World Evidence Demonstrating the Efficacy of Fetcroja/Fetroja (Cefiderocol)"[4].