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FERAHEME Drug Profile
» See Plans and Pricing
When do Feraheme patents expire, 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.
US ANDA Litigation and Generic Entry Outlook for Feraheme
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for FERAHEME
| International Patents: | 13 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 4 |
| Clinical Trials: | 46 |
| 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 |
Recent Clinical Trials for FERAHEME
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jodi Maranchie | Early Phase 1 |
| Thomas Jefferson University | Phase 4 |
| NYU Langone Health | Phase 4 |
Pharmacology for FERAHEME
| Drug Class | Parenteral Iron Replacement |
Paragraph IV (Patent) Challenges for FERAHEME
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FERAHEME | SOLUTION;INTRAVENOUS | ferumoxytol | 022180 | 2015-12-04 |
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 | 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 | 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 | ||
| >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
| 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 FERAHEME
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5064612 | Start Trial |
| Germany | 60043188 | Start Trial |
| Austria | 446108 | Start Trial |
| European Patent Office | 1522318 | Start Trial |
| European Patent Office | 1169062 | Start Trial |
| Spain | 2334555 | Start Trial |
| Japan | 2011046752 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FERAHEME
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1169062 | 92114 | Luxembourg | Start Trial | PRODUCT NAME: FERUMOXYTOL |
| 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 | 2012C/052 | Belgium | Start Trial | PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620 |
| 1169062 | 1290043-7 | Sweden | Start Trial | PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 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 | C01169062/01 | Switzerland | Start Trial | PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012 |
| 1169062 | CA 2012 00050 | Denmark | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
