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

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			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 CEFIDEROCOL SULFATE TOSYLATE

Country	Patent Number	Title	Estimated Expiration
Serbia	55365	CEFALOSPORIN SA KATEHOLSKOM GRUPOM (CEPHALOSPORIN HAVING CATECHOL GROUP)
Taiwan	I535727
Netherlands	301067
Eurasian Patent Organization	035845	СОЛЬ ПРОИЗВОДНОГО ЦЕФАЛОСПОРИНА, ЕЕ КРИСТАЛЛИЧЕСКОЕ ТВЕРДОЕ ВЕЩЕСТВО И СПОСОБ ЕЕ ПОЛУЧЕНИЯ (SALT OF CEPHALOSPORIN DERIVATIVE, CRYSTALLINE SOLID FORM THEREOF AND METHOD FOR PRODUCING SAME)
Colombia	6331443	CEFAROSPORINAS QUE TIENEN UN GRUPO CATECOL

Supplementary Protection Certificates for CEFIDEROCOL SULFATE TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2020530,C2960244	Lithuania		PRODUCT NAME: CEFIDEROKOLAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1434 20200423
2960244	PA2020530	Lithuania		PRODUCT NAME: CEFIDEROKOLAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1434 20200423
2960244	SPC/GB20/053	United Kingdom		PRODUCT NAME: CEFIDEROCOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; REGISTERED: UK EU/1/20/1434 (NI) 20200424; UK PLGB 50999/0009 20200424
2960244	C20200033 00355	Estonia		PRODUCT NAME: TSEFIDEROKOOL;REG NO/DATE: EU/1/20/1434 24.04.2020