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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-two 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:	82
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	4
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

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
University of Texas	Phase 4
Keystone Bioanalytical, Inc.	Phase 4
University of Pittsburgh Medical Center	Phase 4

See all FETROJA clinical trials

Pharmacology for FETROJA

Drug Class

Cephalosporin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for FETROJA

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 FETROJA

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

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

Patents protecting FETROJA

FDA Regulatory Exclusivity protecting FETROJA

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			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			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			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

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	2014065732	CEPHALOSPORINS HAVING CATECHOL GROUP
Canada	2736953	CEPHALOSPORINE POSSEDANT UN GROUPE CATECHOL (CEPHAROSPORINS HAVING A CATECHOL GROUP)
Japan	WO2016035846	カテコール基を有するセファロスポリン類を含有する製剤
Costa Rica	20110144	CEFALOSPORIN TENIENDO GRUPO CATECOL
Morocco	40585	SEL DE DÉRIVÉ DE CÉPHALOSPORINE, FORME SOLIDE CRISTALLINE DE CELUI-CI ET SON PROCÉDÉ DE PRODUCTION
Spain	2564836
Taiwan	I593690

Supplementary Protection Certificates for FETROJA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2960244	43/2020	Austria		PRODUCT NAME: CEFIDEROCOL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/20/1434 (MITTEILUNG) 20200424
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	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	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
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
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