FERUMOXYTOL - Generic Drug Details

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What are the generic drug sources for ferumoxytol and what is the scope of freedom to operate?

Ferumoxytol is the generic ingredient in two branded drugs marketed by Covis and Sandoz, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for ferumoxytol. Two suppliers are listed for this compound.

Summary for FERUMOXYTOL

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	86
Drug Prices:	Drug price trends for FERUMOXYTOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERUMOXYTOL
What excipients (inactive ingredients) are in FERUMOXYTOL?	FERUMOXYTOL excipients list
DailyMed Link:	FERUMOXYTOL at DailyMed

See drug prices for FERUMOXYTOL

Recent Clinical Trials for FERUMOXYTOL

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

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

See all FERUMOXYTOL clinical trials

Pharmacology for FERUMOXYTOL

Drug Class	Parenteral Iron Replacement

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

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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
Sandoz	FERUMOXYTOL	ferumoxytol	SOLUTION;INTRAVENOUS	206604-001	Jan 15, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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 FERUMOXYTOL

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for FERUMOXYTOL

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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

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