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Ferric carboxymaltose - Generic Drug Details

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What are the generic sources for ferric carboxymaltose and what is the scope of ferric carboxymaltose patent protection?

Ferric carboxymaltose is the generic ingredient in one branded drug marketed by Luitpold and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric carboxymaltose has sixty-six patent family members in thirty-one countries.

There are twenty drug master file entries for ferric carboxymaltose. One supplier is listed for this compound.

Summary for ferric carboxymaltose

International Patents:	66
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	20
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	83
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ferric carboxymaltose
DailyMed Link:	ferric carboxymaltose at DailyMed

Pharmacology for ferric carboxymaltose

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

US Patents and Regulatory Information for ferric carboxymaltose

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	Y
Luitpold	INJECTAFER	ferric carboxymaltose	INJECTABLE;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes			Y

International Patents for ferric carboxymaltose

Country	Document Number	Estimated Expiration
Japan	5289413
Hong Kong	1125044
Portugal	2287204
Spain	2602433
Lithuania	1973549