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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 one branded drug marketed by Amag Pharms Inc and is included in one NDA. There are six patents 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. One supplier is listed for this compound.
Summary for FERUMOXYTOL
| International Patents: | 13 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 4 |
| Clinical Trials: | 71 |
| Formulation / Manufacturing: | see details |
| 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 |
Recent Clinical Trials for FERUMOXYTOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jodi Maranchie | Early Phase 1 |
| Auerbach Hematology and Oncology | Phase 4 |
| Auerbach Hematology Oncology Associates P C | Phase 3 |
Pharmacology for FERUMOXYTOL
| Drug Class | Parenteral Iron Replacement |
Paragraph IV (Patent) Challenges for FERUMOXYTOL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FERAHEME | SOLUTION;INTRAVENOUS | ferumoxytol | 022180 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 |
|---|---|---|---|---|---|---|---|
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | Start Trial | Start Trial |
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | Start Trial | Start Trial |
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | Start Trial | Start Trial |
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | Start Trial | Start Trial |
| Amag Pharms Inc | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FERUMOXYTOL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5064612 | Start Trial |
| Austria | 446108 | Start Trial |
| Japan | 2002541218 | Start Trial |
| Luxembourg | 92114 | Start Trial |
| Spain | 2334555 | Start Trial |
| Japan | 2011046752 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0061191 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FERUMOXYTOL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1169062 | C300558 | Netherlands | Start Trial | PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615 |
| 1169062 | 300558 | Netherlands | Start Trial | 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 | Start Trial | |
| 1169062 | 1290043-7 | Sweden | Start Trial | PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615 |
| 1169062 | C01169062/01 | Switzerland | Start Trial | PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012 |
| 1169062 | 92114 | Luxembourg | Start Trial | PRODUCT NAME: FERUMOXYTOL |
| 1169062 | 2012C/052 | Belgium | Start Trial | PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620 |
| >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.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2021, www.DrugPatentWatch.com.
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