FERAHEME Drug Patent Profile

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

Feraheme is a drug marketed by Covis and is included in one NDA. There is one patent 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. Two suppliers are listed for this compound. Additional details are available on the ferumoxytol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Feraheme

A generic version of FERAHEME was approved as ferumoxytol by SANDOZ INC on January 15^th, 2021.

Summary for FERAHEME

International Patents:	13
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	55
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FERAHEME
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERAHEME
What excipients (inactive ingredients) are in FERAHEME?	FERAHEME excipients list
DailyMed Link:	FERAHEME at DailyMed

See drug prices for FERAHEME

Recent Clinical Trials for FERAHEME

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

Sponsor	Phase
Bryan Allen	Phase 1
Holden Comprehensive Cancer Center	Phase 1
University of Wisconsin, Madison	Early Phase 1

See all FERAHEME clinical trials

Paragraph IV (Patent) Challenges for FERAHEME

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 FERAHEME

FERAHEME is protected by one US patents.

Patents protecting FERAHEME

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	AB	RX	Yes	Yes			Y	Y

Expired US Patents for FERAHEME

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

International Patents for FERAHEME

See the table below for patents covering FERAHEME around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1169062
Japan	2011046752	HEAT STABLE COLLOIDAL IRON OXIDE COATED WITH REDUCED CARBOHYDRATE AND CARBOHYDRATE DERIVATIVE
European Patent Office	1169062	OXYDES DE FER COLLOIDAUX THERMOSTABLES RECOUVERTS DE CARBOHYDRATES REDUITS ET DES DERIVES DE CARBOHYDRATES (HEAT STABLE COATED COLLOIDAL IRON OXIDES)
Japan	5064612
Japan	2002541218
Austria	446108

Supplementary Protection Certificates for FERAHEME

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169062	C01169062/01	Switzerland		PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012
1169062	1290043-7	Sweden		PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615
1169062	C300558	Netherlands		PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
1169062	300558	Netherlands		PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
1169062	92114	Luxembourg		PRODUCT NAME: FERUMOXYTOL
1169062	2012C/052	Belgium		PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620