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Last Updated: October 18, 2019

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FERAHEME Drug Profile

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Which patents cover Feraheme, 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.

Drug patent expirations by year for FERAHEME
Drug Prices for FERAHEME

See drug prices for FERAHEME

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
NYU Langone HealthPhase 4
Radiological Society of North AmericaPhase 2
National Cancer Institute (NCI)Early Phase 1

See all FERAHEME clinical trials

Recent Litigation for FERAHEME

Identify potential future generic entrants

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

See all FERAHEME litigation

Pharmacology for FERAHEME
Synonyms for FERAHEME
AC1L24JX
hydroxy(oxo)iron; iron

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for FERAHEME
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 30 mg/mL, 17 mL single-use vials ➤ Subscribe   Start Trial

Supplementary Protection Certificates for FERAHEME

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 2012C/052 Belgium   Start Trial PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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