Exjade is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 23, 2023. Details of Exjade's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6465504 | Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators |
Apr, 2019
(5 years ago) |
Expired
|
| US6596750 | Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators |
Jun, 2017
(7 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 Exjade's patents.
Latest Legal Activities on Exjade's Patents
Given below is the list of recent legal activities going on the following patents of Exjade.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 22 Jul, 2003 | US6596750 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 22 Jul, 2003 | US6596750 (Litigated) |
| Issue Notification Mailed Critical | 02 Jul, 2003 | US6596750 (Litigated) |
| Receipt into Pubs | 09 Jun, 2003 | US6596750 (Litigated) |
| Application Is Considered Ready for Issue Critical | 06 Jun, 2003 | US6596750 (Litigated) |
| Receipt into Pubs | 02 Jun, 2003 | US6596750 (Litigated) |
| Issue Fee Payment Verified Critical | 27 May, 2003 | US6596750 (Litigated) |
| Issue Fee Payment Received Critical | 27 May, 2003 | US6596750 (Litigated) |
| Workflow - File Sent to Contractor | 11 Apr, 2003 | US6596750 (Litigated) |
| Receipt into Pubs | 04 Apr, 2003 | US6596750 (Litigated) |
FDA has granted several exclusivities to Exjade. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Exjade, 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 Exjade.
Exclusivity Information
Exjade holds 6 exclusivities. All of its exclusivities have expired in 2023. Details of Exjade's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Nov 02, 2012 |
| New Indication(I-665) | Jan 23, 2016 |
| Orphan Drug Exclusivity(ODE-39) | Jan 23, 2020 |
| M(M-239) | Dec 12, 2021 |
| M(M-241) | Jul 24, 2022 |
| M(M-263) | Jul 23, 2023 |
US patents provide insights into the exclusivity only within the United States, but Exjade 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 Exjade's family patents as well as insights into ongoing legal events on those patents.
Exjade's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Exjade's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 23, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Exjade Generic API suppliers:
Deferasirox is the generic name for the brand Exjade. 19 different companies have already filed for the generic of Exjade, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Exjade's generic
How can I launch a generic of Exjade before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Exjade's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Exjade'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 Exjade -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 125 mg, 250 mg, and 500 mg | 28 Oct, 2011 | 1 | 26 Jan, 2016 | 05 Apr, 2019 | Eligible |
Alternative Brands for Exjade
Exjade which is used for managing chronic iron overload., has several other brand drugs in the same treatment category and using the same active ingredient (Deferasirox). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Novartis Pharms Corp |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Deferasirox. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Novartis |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Deferasirox, Exjade's active ingredient. Check the complete list of approved generic manufacturers for Exjade
About Exjade
Exjade is a drug owned by Novartis Pharmaceuticals Corp. It is used for managing chronic iron overload. Exjade uses Deferasirox as an active ingredient. Exjade was launched by Novartis in 2005.
Approval Date:
Exjade was approved by FDA for market use on 02 November, 2005.
Active Ingredient:
Exjade uses Deferasirox as the active ingredient. Check out other Drugs and Companies using Deferasirox ingredient
Treatment:
Exjade is used for managing chronic iron overload.
Dosage:
Exjade is available in tablet, for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG | TABLET, FOR SUSPENSION | Prescription | ORAL |
| 500MG | TABLET, FOR SUSPENSION | Prescription | ORAL |
| 125MG | TABLET, FOR SUSPENSION | Prescription | ORAL |