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FERUMOXYTOL - Generic Drug Details

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.

Ferumoxytol has thirteen patent family members in ten countries.

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

Summary for FERUMOXYTOL

International Patents:	13
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	5
Clinical Trials:	59
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

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Glossary

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

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Non-Orange Book US Patents for FERUMOXYTOL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
9,555,133	Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

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International Patents for FERUMOXYTOL

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Country	Document Number	Estimated Expiration
Denmark	1169062	➤ Sign Up
Japan	2011046752	➤ Sign Up
European Patent Office	1169062	➤ Sign Up
Japan	5064612	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for FERUMOXYTOL

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169062/01	Switzerland	➤ Sign Up	PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012
90043-7	Sweden	➤ Sign Up	PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615
00558	Netherlands	➤ Sign Up	PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
0558	Netherlands	➤ Sign Up	PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description