DrugPatentWatch Database Preview
FERAHEME Drug Profile
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: | 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 |
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 | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Paragraph IV (Patent) Challenges for FERAHEME
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 30 mg/mL, 17 mL single-use vials | ➤ Subscribe | Start Trial |
International Patents for FERAHEME
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2002541218 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0061191 | Start Trial |
| Cyprus | 1109527 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FERAHEME
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1169062 | CA 2012 00050 | Denmark | Start Trial | |
| 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 | 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 |
