Jadenu is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 3 US drug patents filed from 2015 to 2016. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 21, 2034. Details of Jadenu'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. | |||
| US6596750 | Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators |
Jun, 2017
(7 years ago) |
Expired
|
| US6465504 | Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators |
Apr, 2019
(5 years ago) |
Expired
|
| US9283209 | Oral formulations of deferasirox |
Nov, 2034
(10 years from now) | Active |
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 Jadenu's patents.
Latest Legal Activities on Jadenu's Patents
Given below is the list of recent legal activities going on the following patents of Jadenu.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Aug, 2023 | US9283209 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Aug, 2019 | US9283209 |
| Patent Issue Date Used in PTA Calculation | 15 Mar, 2016 | US9283209 |
| Recordation of Patent Grant Mailed | 15 Mar, 2016 | US9283209 |
| Email Notification | 25 Feb, 2016 | US9283209 |
| Issue Notification Mailed | 24 Feb, 2016 | US9283209 |
| Dispatch to FDC | 11 Feb, 2016 | US9283209 |
| Application Is Considered Ready for Issue | 11 Feb, 2016 | US9283209 |
| Issue Fee Payment Received | 05 Feb, 2016 | US9283209 |
| Issue Fee Payment Verified | 05 Feb, 2016 | US9283209 |
FDA has granted several exclusivities to Jadenu. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jadenu, 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 Jadenu.
Exclusivity Information
Jadenu holds 5 exclusivities. All of its exclusivities have expired in 2023. Details of Jadenu's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE-39) | Jan 23, 2020 |
| Orphan Drug Exclusivity(ODE) | Jan 23, 2020 |
| M(M-239) | Dec 12, 2021 |
| M(M-241) | Jul 24, 2022 |
| M(M-263) | Jul 23, 2023 |
Several oppositions have been filed on Jadenu's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Jadenu's generic, the next section provides detailed information on ongoing and past EP oppositions related to Jadenu patents.
Jadenu's oppositions filed in EPO
Jadenu has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 20, 2018, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP16188627A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14710654A | Jul, 2019 | INVOKAT Intellectual Property Services | Patent maintained as amended |
| EP14710654A | Jul, 2019 | HGF Limited | Patent maintained as amended |
| EP14710654A | Jul, 2019 | Teva Pharmaceutical Industries Ltd | Patent maintained as amended |
| EP16188627A | Sep, 2018 | HGF Limited | Granted and Under Opposition |
| EP16188627A | Sep, 2018 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Jadenu 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 Jadenu's family patents as well as insights into ongoing legal events on those patents.
Jadenu's family patents
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Generic Launch
Generic Release Date:
Jadenu's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 21, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jadenu Generics:
Deferasirox is the generic name for the brand Jadenu. 18 different companies have already filed for the generic of Jadenu, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Jadenu's generic
How can I launch a generic of Jadenu before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Jadenu's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Jadenu'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 Jadenu -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 90 mg and 360 mg | 19 Oct, 2015 | 1 | 05 Apr, 2019 | Extinguished | |
| 180 mg | 21 Apr, 2016 | 1 | 13 Dec, 2019 | 21 Nov, 2034 | Eligible |
About Jadenu
Jadenu is a drug owned by Novartis Pharmaceuticals Corp. It is used for managing chronic iron overload. Jadenu uses Deferasirox as an active ingredient. Jadenu was launched by Novartis Pharms Corp in 2015.
Market Authorisation Date:
Jadenu was approved by FDA for market use on 30 March, 2015.
Active Ingredient:
Jadenu uses Deferasirox as the active ingredient. Check out other Drugs and Companies using Deferasirox ingredient
Treatment:
Jadenu is used for managing chronic iron overload.
Dosage:
Jadenu is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 90MG | TABLET | Prescription | ORAL |
| 180MG | TABLET | Prescription | ORAL |
| 360MG | TABLET | Prescription | ORAL |