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Last Updated: January 27, 2023

Ferumoxytol - Generic Drug Details


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What are the generic sources for ferumoxytol and what is the scope of patent protection?

Ferumoxytol is the generic ingredient in two branded drugs marketed by Covis and Sandoz Inc, and is included in two NDAs. There is one patent 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. Two suppliers are listed for this compound.

Recent Clinical Trials for ferumoxytol

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

SponsorPhase
University of WashingtonPhase 2
Pharmacosmos Therapeutics, Inc.Phase 3
Baylor College of MedicinePhase 3

See all ferumoxytol clinical trials

Pharmacology for ferumoxytol
Paragraph IV (Patent) Challenges for FERUMOXYTOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FERAHEME Injection ferumoxytol 30 mg/mL, 17 mL single-use vials 022180 1 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
Sandoz Inc FERUMOXYTOL ferumoxytol SOLUTION;INTRAVENOUS 206604-001 Jan 15, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Covis FERAHEME ferumoxytol SOLUTION;INTRAVENOUS 022180-001 Jun 30, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 ferumoxytol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis FERAHEME ferumoxytol SOLUTION;INTRAVENOUS 022180-001 Jun 30, 2009 See Plans and Pricing See Plans and Pricing
Covis FERAHEME ferumoxytol SOLUTION;INTRAVENOUS 022180-001 Jun 30, 2009 See Plans and Pricing See Plans and Pricing
Covis FERAHEME ferumoxytol SOLUTION;INTRAVENOUS 022180-001 Jun 30, 2009 See Plans and Pricing See Plans and Pricing
Covis FERAHEME ferumoxytol SOLUTION;INTRAVENOUS 022180-001 Jun 30, 2009 See Plans and Pricing See Plans and Pricing
Covis FERAHEME ferumoxytol SOLUTION;INTRAVENOUS 022180-001 Jun 30, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ferumoxytol

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharma A/S Rienso ferumoxytol EMEA/H/C/002215
Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD).The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).
Withdrawn no no no 2012-06-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ferumoxytol

Country Patent Number Title Estimated Expiration
Japan 5064612 See Plans and Pricing
Cyprus 1109527 See Plans and Pricing
World Intellectual Property Organization (WIPO) 0061191 See Plans and Pricing
Denmark 1169062 See Plans and Pricing
Luxembourg 92114 See Plans and Pricing
Japan 2011046752 HEAT STABLE COLLOIDAL IRON OXIDE COATED WITH REDUCED CARBOHYDRATE AND CARBOHYDRATE DERIVATIVE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ferumoxytol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1169062 300558 Netherlands See Plans and Pricing PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
1169062 CA 2012 00050 Denmark See Plans and Pricing
1169062 C01169062/01 Switzerland See Plans and Pricing PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012
1169062 2012C/052 Belgium See Plans and Pricing PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620
1169062 C300558 Netherlands See Plans and Pricing PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
1169062 92114 Luxembourg See Plans and Pricing PRODUCT NAME: FERUMOXYTOL
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.