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 seventy-nine patent family members in thirty-six 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 will be eligible for patent challenges on November 14, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:	79
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	4
Patent Applications:	31
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 Generic Entry Opportunity 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 three US patents and three 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
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			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 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:

China

European Patent Office

Japan

South Korea

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
China	106795176	头孢菌素衍生物的盐、其结晶固体及其制造方法 (Salt of cephalosporin derivative, crystalline solid form of same and method for producing same)
Japan	WO2010050468	カテコール基を有するセファロスポリン類
Serbia	62449	SO DERIVATA CEFALOSPORINA, NJEN KRISTALNI ČVRST OBLIK I POSTUPAK NJENE PROIZVODNJE (SALT OF CEPHALOSPORIN DERIVATIVE, CRYSTALLINE SOLID FORM OF SAME AND METHOD FOR PRODUCING SAME)
Spain	2602969
New Zealand	591728	CEPHALOSPORIN HAVING CATECHOL GROUP
Netherlands	301067
European Patent Office	2960244	CÉPHALOSPORINE COMPRENANT UN GROUPE CATÉCHOL (CEPHALOSPORIN HAVING CATECHOL GROUP)

Supplementary Protection Certificates for FETROJA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2960244	122020000060	Germany		PRODUCT NAME: CEFIDEROCOL; REGISTRATION NO/DATE: EU/1/20/1434 20200423
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	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	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
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
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