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Chinese Patent Office
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Generated: July 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022180

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NDA 022180 describes FERAHEME, which is a drug marketed by Amag Pharms Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FERAHEME profile page.

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.
Summary for 022180
Tradename:FERAHEME
Applicant:Amag Pharms Inc
Ingredient:ferumoxytol
Patents:6
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022180
Generic Entry Date for 022180*:
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
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 NDA: 022180
Ingredient-typeIron
Suppliers and Packaging for NDA: 022180
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FERAHEME ferumoxytol SOLUTION;INTRAVENOUS 022180 NDA AMAG Pharmaceuticals, Inc. 59338-775 N 59338-775-01
FERAHEME ferumoxytol SOLUTION;INTRAVENOUS 022180 NDA AMAG Pharmaceuticals, Inc. 59338-775 N 59338-775-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 510MG IRON/17ML (EQ 30MG IRON/ML)
Approval Date:Jun 30, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 2, 2021
Regulatory Exclusivity Use:TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON
Patent:➤ Sign UpPatent Expiration:Jun 30, 2023Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Mar 8, 2020Product Flag?YSubstance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Healthtrust
Queensland Health
Cantor Fitzgerald
Julphar
AstraZeneca
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Farmers Insurance

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