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FERUMOXYTOL - Generic Drug Details

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What are the generic drug sources for ferumoxytol and what is the scope of ferumoxytol freedom to operate?

Ferumoxytol is the generic ingredient in one branded drug marketed by Amag Pharms Inc and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for ferumoxytol. One supplier is listed for this compound.

Summary for FERUMOXYTOL

US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	4
Clinical Trials:	61
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERUMOXYTOL
DailyMed Link:	FERUMOXYTOL at DailyMed

Pharmacology for FERUMOXYTOL

Ingredient-type	Iron
Drug Class	Parenteral Iron Replacement

Synonyms for FERUMOXYTOL

722492-56-0

AC1L24JX

BIS(IRON(III) OXIDE-HYDROXIDE) IRON

C 7228

Cytogen

D06CTM

D0Y1KF

Feraheme (TN)

Feraheme/ Rienso

hydroxy(oxo)iron; iron

IN004303

US Patents and Regulatory Information for FERUMOXYTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amag Pharms Inc	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009		RX	Yes	Yes			Y	Y
Amag Pharms Inc	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009		RX	Yes	Yes			Y
Amag Pharms Inc	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009		RX	Yes	Yes			Y	Y
Amag Pharms Inc	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009		RX	Yes	Yes
Amag Pharms Inc	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009		RX	Yes	Yes			Y	Y

International Patents for FERUMOXYTOL

Country	Document Number	Estimated Expiration
Japan	5064612
Denmark	1169062
Cyprus	1109527
Japan	2002541218
Spain	2334555

Supplementary Protection Certificates for FERUMOXYTOL

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169062/01	Switzerland		PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012
2012 00050	Denmark
0558	Netherlands		PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
114	Luxembourg		PRODUCT NAME: FERUMOXYTOL
00558	Netherlands		PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615