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Last Updated: July 5, 2020

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FERAHEME Drug Profile


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When do Feraheme patents expire, and what generic alternatives are available?

Feraheme is a drug marketed by Amag Pharms Inc and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in ten countries.

The generic ingredient in FERAHEME is ferumoxytol. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ferumoxytol profile page.

US ANDA Litigation and Generic Entry Outlook for Feraheme

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 2, 2021. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for FERAHEME
Drug Prices for FERAHEME

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Generic Entry Opportunity Date for FERAHEME
Generic Entry Date for FERAHEME*:
Constraining patent/regulatory exclusivity:
TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FERAHEME

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

SponsorPhase
Jodi MaranchieEarly Phase 1
Thomas Jefferson UniversityPhase 4
NYU Langone HealthPhase 4

See all FERAHEME clinical trials

Pharmacology for FERAHEME
Paragraph IV (Patent) Challenges for FERAHEME
Tradename Dosage Ingredient NDA Submissiondate
FERAHEME SOLUTION;INTRAVENOUS ferumoxytol 022180 2015-12-04

US Patents and Regulatory Information for FERAHEME

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   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

Expired US Patents for FERAHEME

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

Supplementary Protection Certificates for FERAHEME

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1169062 92114 Luxembourg   Start Trial PRODUCT NAME: FERUMOXYTOL
1169062 CA 2012 00050 Denmark   Start Trial
1169062 C01169062/01 Switzerland   Start Trial PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012
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 300558 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:

Mallinckrodt
Harvard Business School
Johnson and Johnson
McKinsey
AstraZeneca
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.