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.
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Summary for FERAHEME
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Clinical Trials: | 60 |
| 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 |
|---|---|
| Christopher J Chermansky, MD | Early Phase 1 |
| National Institutes of Health (NIH) | Early Phase 1 |
| Lipella Pharmaceuticals, Inc. | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Denmark | 1169062 | ⤷ Sign Up | |
| Germany | 60043188 | ⤷ Sign Up | |
| Japan | 2002541218 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012 |
| 1169062 | 92114 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: FERUMOXYTOL |
| 1169062 | 2012C/052 | Belgium | ⤷ Sign Up | PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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