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.
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 on January 15th, 2021.
Summary for FERAHEME
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 9 |
Clinical Trials: | 59 |
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 |
---|---|
Lipella Pharmaceuticals, Inc. | Early Phase 1 |
Christopher J Chermansky, MD | Early Phase 1 |
National Institutes of Health (NIH) | Early Phase 1 |
Pharmacology for FERAHEME
Drug Class | Parenteral Iron Replacement |
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
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for FERAHEME
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Takeda Pharma A/S | Rienso | ferumoxytol | EMEA/H/C/002215 Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD).The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2). |
Withdrawn | no | no | no | 2012-06-15 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for FERAHEME
See the table below for patents covering FERAHEME around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5064612 | ⤷ Try a Trial | |
European Patent Office | 1522318 | ⤷ Try a Trial | |
Spain | 2334555 | ⤷ Try a Trial | |
Japan | 2002541218 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FERAHEME
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1169062 | 2012C/052 | Belgium | ⤷ Try a Trial | PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620 |
1169062 | C300558 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615 |
1169062 | 92114 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: FERUMOXYTOL |
1169062 | C01169062/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |