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Julphar
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Cerilliant
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Daiichi Sankyo
Queensland Health
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Generated: November 16, 2018

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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.

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
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.

Pharmacology for FERAHEME
Ingredient-typeIron
Drug ClassParenteral Iron Replacement

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 ➤ 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 ➤ 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 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 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
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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Paragraph IV (Patent) Challenges for FERAHEME
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 30 mg/mL, 17 mL single-use vials ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for FERAHEME

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
114 Luxembourg ➤ Sign Up PRODUCT NAME: FERUMOXYTOL
2012 00050 Denmark ➤ Sign Up
0558 Netherlands ➤ Sign Up PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
90043-7 Sweden ➤ Sign Up PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615
1169062/01 Switzerland ➤ Sign Up PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012
00558 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

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
UBS
Farmers Insurance
Cerilliant
Deloitte
McKesson
Daiichi Sankyo
Queensland Health
Boehringer Ingelheim

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