Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Express Scripts
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Boehringer Ingelheim

Last Updated: November 18, 2019

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Ferumoxytol - Generic Drug Details

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What are the generic 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.

Recent Clinical Trials for ferumoxytol

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SponsorPhase
NYU Langone HealthPhase 4
Johns Hopkins UniversityN/A
IpsenPhase 1/Phase 2

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Recent Litigation for ferumoxytol

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District Court Litigation
Case NameDate
AMAG PHARMACEUTICALS, INC. v. SANDOZ INC.2016-03-17

See all ferumoxytol litigation

Pharmacology for ferumoxytol
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

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 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
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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ferumoxytol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1169062 CA 2012 00050 Denmark   Start Trial
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 92114 Luxembourg   Start Trial PRODUCT NAME: FERUMOXYTOL
1169062 2012C/052 Belgium   Start Trial PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620
1169062 C01169062/01 Switzerland   Start Trial PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012
1169062 1290043-7 Sweden   Start Trial PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Merck
Express Scripts
Baxter
AstraZeneca

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