Feraheme Patent Expiration

Feraheme is a drug owned by Covis Pharma Gmbh. It is protected by 6 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 02, 2021. Details of Feraheme's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8926947 Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Mar, 2020

(4 years ago)

Expired
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8501158 Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Mar, 2020

(4 years ago)

Expired
US8591864 Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Mar, 2020

(4 years ago)

Expired
US6599498 Heat stable colloidal iron oxides coated with reduced carbohydrates and carbohdrate derivatives
Mar, 2020

(4 years ago)

Expired
US7553479 Heat stable colloidal iron oxides coated with reduced carbohydrates and uses thereof
Mar, 2020

(4 years ago)

Expired
US7871597 Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Mar, 2020

(4 years ago)

Expired


FDA has granted several exclusivities to Feraheme. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Feraheme, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Feraheme.

Exclusivity Information

Feraheme holds 2 exclusivities. All of its exclusivities have expired in 2021. Details of Feraheme's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Jun 30, 2012
New Indication(I-767) Feb 02, 2021

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US patents provide insights into the exclusivity only within the United States, but Feraheme is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Feraheme's family patents as well as insights into ongoing legal events on those patents.

Feraheme's family patents


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Generic Launch

Generic Release Date:

Feraheme's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 02, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Feraheme Generics:

Ferumoxytol is the generic name for the brand Feraheme. 1 company has already filed for the generic of Feraheme. Check out the entire list of companies who have already received approval for Feraheme's generic

How can I launch a generic of Feraheme before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Feraheme's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Feraheme's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Feraheme -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
30 mg/mL, 17 mL single-use vials 04 Dec, 2015 1 15 Jan, 2021 30 Jun, 2023 Deferred




About Feraheme

Feraheme is a drug owned by Covis Pharma Gmbh. It is used for treating iron deficiency in patients. Feraheme uses Ferumoxytol as an active ingredient. Feraheme was launched by Covis in 2009.

Market Authorisation Date:

Feraheme was approved by FDA for market use on 30 June, 2009.

Active Ingredient:

Feraheme uses Ferumoxytol as the active ingredient. Check out other Drugs and Companies using Ferumoxytol ingredient

Treatment:

Feraheme is used for treating iron deficiency in patients.

Dosage:

Feraheme is available in solution form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION Prescription INTRAVENOUS