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 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: | 8 |
| 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 |
|---|---|
| National Institutes of Health (NIH) | Early Phase 1 |
| Lipella Pharmaceuticals, Inc. | Early Phase 1 |
| Christopher J Chermansky, MD | 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
FERAHEME is protected by one US patents.
Patents protecting FERAHEME
Heat stable colloidal iron oxides coated with reduced carbohydrates and carbohdrate derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Covis | FERAHEME | ferumoxytol | SOLUTION;INTRAVENOUS | 022180-001 | Jun 30, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 |
| 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 |
|---|---|---|---|
| Spain | 2334555 | ⤷ Try a Trial | |
| Denmark | 1169062 | ⤷ Try a Trial | |
| Japan | 5064612 | ⤷ Try a Trial | |
| European Patent Office | 1522318 | ⤷ Try a Trial | |
| Portugal | 1169062 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 0061191 | ⤷ Try a Trial | |
| Luxembourg | 92114 | ⤷ 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 | C01169062/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012 |
| 1169062 | 2012C/052 | Belgium | ⤷ Try a Trial | PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620 |
| 1169062 | CA 2012 00050 | Denmark | ⤷ Try a Trial | |
| 1169062 | 300558 | 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 | 1290043-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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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