FERAHEME Drug Patent Profile

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

Feraheme is a drug marketed by Covis and is included in one NDA.

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 on January 15^th, 2021.

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Summary for FERAHEME

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	60
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

Drug patent expirations by year for FERAHEME

Recent Clinical Trials for FERAHEME

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

Sponsor	Phase
Christopher J Chermansky, MD	Early Phase 1
National Institutes of Health (NIH)	Early Phase 1
Lipella Pharmaceuticals, Inc.	Early Phase 1

See all FERAHEME clinical trials

Pharmacology for FERAHEME

Drug Class	Parenteral Iron Replacement

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 FERAHEME

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

EU/EMA Drug Approvals for FERAHEME

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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 FERAHEME

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1522318		⤷ Sign Up
Germany	60043188		⤷ Sign Up
Spain	2334555		⤷ Sign Up
Portugal	1169062		⤷ Sign Up
European Patent Office	1169062	OXYDES DE FER COLLOIDAUX THERMOSTABLES RECOUVERTS DE CARBOHYDRATES REDUITS ET DES DERIVES DE CARBOHYDRATES (HEAT STABLE COATED COLLOIDAL IRON OXIDES)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FERAHEME

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169062	2012C/052	Belgium	⤷ Sign Up	PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620
1169062	92114	Luxembourg	⤷ Sign Up	PRODUCT NAME: FERUMOXYTOL
1169062	1290043-7	Sweden	⤷ Sign Up	PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615
1169062	CA 2012 00050	Denmark	⤷ Sign Up
1169062	300558	Netherlands	⤷ Sign Up	PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description