FERUMOXYTOL Drug Patent Profile
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When do Ferumoxytol patents expire, and what generic alternatives are available?
Ferumoxytol is a drug marketed by Sandoz and is included in one NDA.
The generic ingredient in FERUMOXYTOL 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 Ferumoxytol
A generic version of FERUMOXYTOL was approved as ferumoxytol by SANDOZ on January 15th, 2021.
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Questions you can ask:
- What is the 5 year forecast for FERUMOXYTOL?
- What are the global sales for FERUMOXYTOL?
- What is Average Wholesale Price for FERUMOXYTOL?
Summary for FERUMOXYTOL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 86 |
| Drug Prices: | Drug price information for FERUMOXYTOL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FERUMOXYTOL |
| DailyMed Link: | FERUMOXYTOL at DailyMed |
Recent Clinical Trials for FERUMOXYTOL
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 FERUMOXYTOL
| Drug Class | Parenteral Iron Replacement |
Paragraph IV (Patent) Challenges for FERUMOXYTOL
| 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 FERUMOXYTOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | FERUMOXYTOL | ferumoxytol | SOLUTION;INTRAVENOUS | 206604-001 | Jan 15, 2021 | AB | RX | No | No | ⤷ 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 |
EU/EMA Drug Approvals for FERUMOXYTOL
| 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 |
