DrugPatentWatch Database Preview

FERAHEME Drug Profile

  Purchase this report

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

Which patents cover Feraheme, and what generic alternatives are available?

Feraheme is a drug marketed by Amag Pharms Inc and is included in one NDA. There are six patents 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. One supplier is listed for this compound. Additional details are available on the ferumoxytol profile page.

Summary for FERAHEME

International Patents:	13
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	5
Clinical Trials:	39
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FERAHEME
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERAHEME
DailyMed Link:	FERAHEME at DailyMed

Generic Entry Opportunity Date for FERAHEME

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

NDA:

022180

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 FERAHEME

Ingredient-type	Iron
Drug Class	Parenteral Iron Replacement

US Patents and Regulatory Information for FERAHEME

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

  Purchase this report

see a sample report or, see our see our flat-rate plans

Paragraph IV (Patent) Challenges for FERAHEME

Drugname	Dosage	Strength	RLD	Date
	Injection	30 mg/mL, 17 mL single-use vials

Non-Orange Book US Patents for FERAHEME

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,555,133	Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents

  Purchase this report

see a sample report or, see our see our flat-rate plans

International Patents for FERAHEME

Country	Document Number	Estimated Expiration
Japan	2011046752
Luxembourg	92114
Cyprus	1109527
Japan	5064612

Supplementary Protection Certificates for FERAHEME

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012 00050	Denmark
114	Luxembourg		PRODUCT NAME: FERUMOXYTOL
90043-7	Sweden		PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615
0558	Netherlands		PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615