Details for New Drug Application (NDA): 209445

NDA 209445 describes FETROJA, which is a drug marketed by Shionogi Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the FETROJA profile page.

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.

Summary for 209445

Tradename:	FETROJA
Applicant:	Shionogi Inc
Ingredient:	cefiderocol sulfate tosylate
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 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.

Pharmacology for NDA: 209445

Suppliers and Packaging for NDA: 209445

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445	NDA	Shionogi Inc.	59630-266	59630-266-10	10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 1GM BASE/VIAL
Approval Date:	Nov 14, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 14, 2029
Regulatory Exclusivity Use:	GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:	Nov 14, 2024
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:		Patent Expiration:	Sep 3, 2035	Product Flag?	Y	Substance Flag?	Y	Delist Request?

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