FERUMOXYTOL - Generic Drug Details

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What are the generic drug sources for ferumoxytol and what is the scope of 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:	4
Clinical Trials:	71
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERUMOXYTOL
DailyMed Link:	FERUMOXYTOL at DailyMed

Recent Clinical Trials for FERUMOXYTOL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Jodi Maranchie	Early Phase 1
Auerbach Hematology and Oncology	Phase 4
Auerbach Hematology Oncology Associates P C	Phase 3

See all FERUMOXYTOL clinical trials

Pharmacology for FERUMOXYTOL

Drug Class	Parenteral Iron Replacement

Paragraph IV (Patent) Challenges for FERUMOXYTOL

Tradename	Dosage	Ingredient	NDA	Submissiondate
FERAHEME	SOLUTION;INTRAVENOUS	ferumoxytol	022180	2015-12-04

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

Expired US Patents for FERUMOXYTOL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amag Pharms Inc	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	Start Trial	Start Trial
Amag Pharms Inc	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	Start Trial	Start Trial
Amag Pharms Inc	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	Start Trial	Start Trial
Amag Pharms Inc	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	Start Trial	Start Trial
Amag Pharms Inc	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FERUMOXYTOL

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Country	Patent Number	Estimated Expiration
Japan	2002541218	Start Trial
Japan	2011046752	Start Trial
World Intellectual Property Organization (WIPO)	0061191	Start Trial
Cyprus	1109527	Start Trial
Germany	60043188	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for FERUMOXYTOL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169062	CA 2012 00050	Denmark	Start Trial
1169062	92114	Luxembourg	Start Trial	PRODUCT NAME: FERUMOXYTOL
1169062	300558	Netherlands	Start Trial	PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
1169062	C300558	Netherlands	Start Trial	PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
1169062	C01169062/01	Switzerland	Start Trial	PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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