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FERAHEME Drug Profile
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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.
US ANDA Litigation and Generic Entry Outlook for Feraheme
Feraheme was eligible for patent challenges on December 31, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 2, 2021. This may change due to patent challenges or generic licensing.
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.
Summary for FERAHEME
| International Patents: | 13 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 4 |
| Clinical Trials: | 44 |
| 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
Generic Entry 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:
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.
Recent Clinical Trials for FERAHEME
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NYU Langone Health | Phase 4 |
| Radiological Society of North America | Phase 2 |
| National Cancer Institute (NCI) | Early Phase 1 |
Recent Litigation for FERAHEME
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| AMAG PHARMACEUTICALS, INC. v. SANDOZ INC. | 2016-03-17 |
Pharmacology for FERAHEME
| Drug Class | Parenteral Iron Replacement |
Synonyms for FERAHEME
| AC1L24JX |
| hydroxy(oxo)iron; iron |
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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for FERAHEME
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0061191 | Start Trial |
| Japan | 2002541218 | Start Trial |
| European Patent Office | 1169062 | Start Trial |
| Germany | 60043188 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FERAHEME
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1169062 | 1290043-7 | Sweden | Start Trial | PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615 |
| 1169062 | 92114 | Luxembourg | Start Trial | PRODUCT NAME: FERUMOXYTOL |
| 1169062 | C01169062/01 | Switzerland | Start Trial | PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
