FERAHEME Drug Patent Profile
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When do Feraheme patents expire, and what generic alternatives are available?
Feraheme is a drug marketed by Covis and is included in one NDA. There is one patent 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. Two suppliers are listed for this compound. Additional details are available on the ferumoxytol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Feraheme
A generic version of FERAHEME was approved as ferumoxytol by SANDOZ INC on January 15th, 2021.
Summary for FERAHEME
International Patents: | 13 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 55 |
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 |
---|---|
Bryan Allen | Phase 1 |
Holden Comprehensive Cancer Center | Phase 1 |
University of Wisconsin, Madison | Early Phase 1 |
Paragraph IV (Patent) Challenges for FERAHEME
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FERAHEME | Injection | ferumoxytol | 30 mg/mL, 17 mL single-use vials | 022180 | 1 | 2015-12-04 |
US Patents and Regulatory Information for FERAHEME
FERAHEME is protected by one US patents.
Patents protecting FERAHEME
Heat stable colloidal iron oxides coated with reduced carbohydrates and carbohdrate derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | |
>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 |
---|---|---|---|---|---|---|---|
Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | See Plans and Pricing | See Plans and Pricing |
Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | See Plans and Pricing | See Plans and Pricing |
Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | See Plans and Pricing | See Plans and Pricing |
Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | See Plans and Pricing | See Plans and Pricing |
Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FERAHEME
See the table below for patents covering FERAHEME around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1169062 | See Plans and Pricing | |
Japan | 2011046752 | HEAT STABLE COLLOIDAL IRON OXIDE COATED WITH REDUCED CARBOHYDRATE AND CARBOHYDRATE DERIVATIVE | See Plans and Pricing |
European Patent Office | 1169062 | OXYDES DE FER COLLOIDAUX THERMOSTABLES RECOUVERTS DE CARBOHYDRATES REDUITS ET DES DERIVES DE CARBOHYDRATES (HEAT STABLE COATED COLLOIDAL IRON OXIDES) | See Plans and Pricing |
Japan | 5064612 | See Plans and Pricing | |
Japan | 2002541218 | See Plans and Pricing | |
Austria | 446108 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FERAHEME
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1169062 | C01169062/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012 |
1169062 | 1290043-7 | Sweden | See Plans and Pricing | PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615 |
1169062 | C300558 | Netherlands | See Plans and Pricing | PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615 |
1169062 | 300558 | Netherlands | See Plans and Pricing | PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615 |
1169062 | 92114 | Luxembourg | See Plans and Pricing | PRODUCT NAME: FERUMOXYTOL |
1169062 | 2012C/052 | Belgium | See Plans and Pricing | PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |