Feraheme is a drug owned by Azurity Pharmaceuticals Inc. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8926947 | Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents |
Mar, 2020
(6 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug 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
(6 years ago) |
Expired
|
| US8591864 | Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents |
Mar, 2020
(6 years ago) |
Expired
|
| US7553479 | Heat stable colloidal iron oxides coated with reduced carbohydrates and uses thereof |
Mar, 2020
(6 years ago) |
Expired
|
| US6599498 | Heat stable colloidal iron oxides coated with reduced carbohydrates and carbohdrate derivatives |
Mar, 2020
(6 years ago) |
Expired
|
| US7871597 | Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents |
Mar, 2020
(6 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Feraheme's patents.
Latest Legal Activities on Feraheme's Patents
Given below is the list of recent legal activities going on the following patents of Feraheme.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 20 Feb, 2023 | US7871597 |
| Expire Patent | 13 Feb, 2023 | US8926947 |
| Maintenance Fee Reminder Mailed
Critical | 05 Sep, 2022 | US7871597 |
| Maintenance Fee Reminder Mailed | 29 Aug, 2022 | US8926947 |
| Expire Patent
Critical | 03 Jan, 2022 | US8591864 |
| Expire Patent
Critical | 13 Sep, 2021 | US8501158 |
| Expire Patent | 02 Aug, 2021 | US7553479 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 19 Jul, 2021 | US8591864 |
| Email Notification | 17 Jun, 2021 | US7553479 (Litigated) |
| Change in Power of Attorney (May Include Associate POA)
Critical | 17 Jun, 2021 | US7871597 |
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 |
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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Feraheme:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 Generic API suppliers:
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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 04 Dec, 2015 | 30 Jun, 2023 | Deferred | 15 Jan, 2021 | Less |
About Feraheme
Feraheme is a drug owned by Azurity Pharmaceuticals Inc. It is used for treating iron deficiency in patients. Feraheme uses Ferumoxytol as an active ingredient. Feraheme was launched by Azurity in 2009.
Approval 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 |