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INJECTAFER Drug Profile

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When do Injectafer patents expire, and when can generic versions of Injectafer launch?

Injectafer is a drug marketed by Luitpold and is included in one NDA. There are four patents protecting this drug.

The generic ingredient in INJECTAFER is ferric carboxymaltose. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric carboxymaltose profile page.

Summary for INJECTAFER

US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	13
Drug Prices:	Drug price information for INJECTAFER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INJECTAFER
DailyMed Link:	INJECTAFER at DailyMed

Generic Entry Opportunity Date for INJECTAFER

NDA:

203565

Dosage:

INJECTABLE;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 INJECTAFER

Ingredient-type	Iron
Drug Class	Parenteral Iron Replacement Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

US Patents and Regulatory Information for INJECTAFER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Luitpold	INJECTAFER	ferric carboxymaltose	INJECTABLE;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes			Y
Luitpold	INJECTAFER	ferric carboxymaltose	INJECTABLE;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes			Y	Y
Luitpold	INJECTAFER	ferric carboxymaltose	INJECTABLE;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes			Y
Luitpold	INJECTAFER	ferric carboxymaltose	INJECTABLE;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes			Y	Y

International Patents for INJECTAFER

Country	Document Number	Estimated Expiration
Japan	5289413
Japan	2006505638
China	100480275
Slovenia	1554315
Hungary	E029259
Norway	20052410