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-two patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for CEFIDEROCOL SULFATE TOSYLATE

International Patents:	82
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Patent Applications:	1
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	10,004,750		Y	Y
Shionogi Inc	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445-001	Nov 14, 2019		RX	Yes	Yes	9,949,982		Y
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

International Patents for CEFIDEROCOL SULFATE TOSYLATE

Country	Patent Number	Title	Estimated Expiration
South Africa	201102024	CEPHALOSPORIN HAVING CATECHOL GROUP
Lithuania	2960244
Israel	211720	תרכובות של צפאלוספורין המכילה קבוצת קטקול, אסטר, מלח תרופתי קביל או סולבט שלהן ו תכשירי רוקחות והשימוש בהם (Compounds of cephalosporin having a catechol group , an ester, a pharmaceutically acceptable salt or a solvate thereof and pharmaceutical compositions thereof and their use as medicaments)
South Korea	20170048511	카테콜기를 갖는 세팔로스포린류를 함유하는 제제 (PHARMACEUTICAL PREPARATION COMPRISING CEPHALOSPORIN HAVING CATECHOL GROUPS)
South Korea	101655961
South Korea	102284990
European Patent Office	3190115	SEL DE DÉRIVÉ DE CÉPHALOSPORINE, FORME SOLIDE CRISTALLINE DE CELUI-CI ET SON PROCÉDÉ DE PRODUCTION (SALT OF CEPHALOSPORIN DERIVATIVE, CRYSTALLINE SOLID FORM OF SAME AND METHOD FOR PRODUCING SAME)

Supplementary Protection Certificates for CEFIDEROCOL SULFATE TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2020035	Norway		PRODUCT NAME: CEFIDEROKOL, EVENTUELT PA FORMEN AV ET FARMASOEYTISK AKSEPTABELT SALT ELLER SOLVAT; REG. NO/DATE: EU/1/20/1434 20200508
2960244	PA2020530	Lithuania		PRODUCT NAME: CEFIDEROKOLAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1434 20200423
2960244	C20200033 00355	Estonia		PRODUCT NAME: TSEFIDEROKOOL;REG NO/DATE: EU/1/20/1434 24.04.2020
2960244	122020000060	Germany		PRODUCT NAME: CEFIDEROCOL; REGISTRATION NO/DATE: EU/1/20/1434 20200423
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	132020000000136	Italy		PRODUCT NAME: CEFIDEROCOL, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE O SOLVATO(FETCROJA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1434, 20200424

CEFIDEROCOL SULFATE TOSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cefiderocol Sulfate Tosylate

Introduction

Cefiderocol sulfate tosylate, marketed under the brand names Fetroja in the U.S. and Fetcroja in Europe, is a significant addition to the arsenal of antibiotics, particularly effective against multidrug-resistant Gram-negative bacteria. This article delves into the market dynamics and financial trajectory of this critical drug.

Mechanism of Action and Clinical Indications

Cefiderocol is a cephalosporin antibacterial drug that operates similarly to other β-lactam antibiotics. It is specifically indicated for the treatment of complicated urinary tract infections (cUTIs) and hospital-acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia[3][4].

Market Need and Demand

The increasing prevalence of multidrug-resistant bacterial infections has created a significant demand for effective antibiotics like cefiderocol. The drug's ability to combat resistant pathogens such as carbapenem-resistant Enterobacteriaceae, multidrug-resistant Pseudomonas aeruginosa, and Acinetobacter baumannii has positioned it as a vital option in the clinical setting[4].

Regulatory Approvals and Designations

Cefiderocol was granted FDA approval in 2019 for cUTIs and later for HABP/ventilator-associated bacterial pneumonia. It also received designation as a Qualified Infectious Disease Product (QIDP) and priority review status, highlighting its importance in addressing critical public health needs[3][4].

Clinical Efficacy

Clinical trials have demonstrated the efficacy of cefiderocol. For instance, a study involving 448 patients with cUTIs showed a 72.6% rate of symptom resolution and bacterial eradication with cefiderocol, compared to 54.6% with imipenem/cilastatin. This study supported its approval and underscored its clinical value[3][4].

Market Performance

The market performance of cefiderocol has been robust, particularly in the U.S. and Europe. According to Shionogi's financial reports, overseas subsidiary sales and exports of cefiderocol increased by 36.2% year on year, contributing significantly to the company's revenue growth. This growth is attributed to the drug's effectiveness against multidrug-resistant bacteria and its increasing market penetration[2].

Financial Impact

Shionogi's financial results reflect the positive impact of cefiderocol on their revenue. In the first quarter of the fiscal year 2023, the company reported a 52.2% increase in revenue compared to the same period in the previous year. This increase was partly driven by the strong performance of cefiderocol, along with other factors such as the transfer of licenses for ADHD drugs and the growth in sales of COVID-19 treatments[2].

Revenue Growth

• Overseas subsidiary sales and exports increased by 36.2% year on year, driven by cefiderocol's performance.
• Domestic sales of prescription drugs, including cefiderocol, increased by 141.6% due to market penetration and other factors[2].

Profitability

• Operating profit increased by 275.0% year on year, with cefiderocol contributing to this significant growth.
• Profit before tax and profit attributable to owners of the parent company also saw substantial increases, reflecting the drug's financial impact[2].

Competitive Landscape

Cefiderocol operates in a competitive landscape of antibiotics, but its unique efficacy against multidrug-resistant pathogens sets it apart. It competes with other antibiotics such as ceftazidime/avibactam and ceftolozane/tazobactam, but its in vitro activity and clinical outcomes have positioned it as a preferred option in many cases[4].

Future Outlook

Given its strong market performance and clinical efficacy, the outlook for cefiderocol remains positive. As the global healthcare system continues to grapple with the challenge of antibiotic resistance, drugs like cefiderocol are expected to play a crucial role. Shionogi has not revised its consolidated financial forecast for the year ending March 31, indicating continued confidence in the drug's market trajectory[2].

Challenges and Considerations

While cefiderocol has shown significant promise, there are challenges to consider. For instance, the drug's sodium content, particularly when reconstituted with sodium chloride injection, is noteworthy. Each 2g dose provides approximately 705 mg of sodium, which is a consideration for patients with sodium restrictions[1].

Drug-Drug Interactions

Cefiderocol has been shown to have minimal drug-drug interactions based on in vitro studies and phase 1 clinical trials, which is a positive aspect for its use in complex clinical scenarios[1].

Key Takeaways

• Market Demand: High demand due to its efficacy against multidrug-resistant Gram-negative bacteria.
• Clinical Efficacy: Demonstrated superior outcomes in clinical trials for cUTIs and HABP.
• Financial Performance: Significant revenue and profit growth for Shionogi driven by cefiderocol sales.
• Competitive Advantage: Unique efficacy profile sets it apart from other antibiotics.
• Future Outlook: Positive outlook due to ongoing need for effective antibiotics against resistant pathogens.

FAQs

Q: What are the primary indications for cefiderocol?

A: Cefiderocol is primarily indicated for the treatment of complicated urinary tract infections (cUTIs) and hospital-acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia[3][4].

Q: How does cefiderocol compare to other antibiotics in terms of efficacy?

A: Cefiderocol has shown superior efficacy against multidrug-resistant pathogens compared to other antibiotics like imipenem/cilastatin in clinical trials[3][4].

Q: What is the sodium content of cefiderocol when reconstituted?

A: When reconstituted with 100 mL of 0.9% sodium chloride injection, each 2g dose of cefiderocol provides approximately 705 mg of sodium[1].

Q: Are there any significant drug-drug interactions associated with cefiderocol?

A: No significant drug-drug interactions are anticipated between cefiderocol and substrates, inhibitors, or inducers of cytochrome P450 enzymes or transporters[1].

Q: How has cefiderocol impacted Shionogi's financial performance?

A: Cefiderocol has significantly contributed to Shionogi's revenue and profit growth, with overseas subsidiary sales and exports increasing by 36.2% year on year[2].

Sources

1. Summary of Product Characteristics (SmPC) for Fetcroja 1 g powder.
2. Consolidated Financial Results for the First Quarter of Fiscal Year 2023 by Shionogi.
3. Cefiderocol: Uses, Interactions, Mechanism of Action - DrugBank.
4. Application for inclusion of FETCROJA/FETROJA on WHO EML.
5. Cefiderocol Sulfate Tosylate | PubChem.