Trisenox is a drug owned by Cephalon Inc. It is protected by 6 US drug patents filed from 2013 to 2018 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 12, 2025. Details of Trisenox'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). | |||
| US6982096 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov, 2018
(6 years ago) |
Expired
|
| US8273379 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov, 2018
(6 years ago) |
Expired
|
| US6855339 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov, 2018
(6 years ago) |
Expired
|
| US6884439 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov, 2018
(6 years ago) |
Expired
|
| US6723351 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov, 2018
(6 years ago) |
Expired
|
| US6861076 | Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol |
Nov, 2018
(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 Trisenox's patents.
Latest Legal Activities on Trisenox's Patents
Given below is the list of recent legal activities going on the following patents of Trisenox.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 02 Nov, 2020 | US8273379 |
| Maintenance Fee Reminder Mailed Critical | 18 May, 2020 | US8273379 |
| Patent Issue Date Used in PTA Calculation Critical | 25 Sep, 2012 | US8273379 |
| Recordation of Patent Grant Mailed Critical | 25 Sep, 2012 | US8273379 |
| Email Notification Critical | 06 Sep, 2012 | US8273379 |
| Issue Notification Mailed Critical | 05 Sep, 2012 | US8273379 |
| Dispatch to FDC | 29 Aug, 2012 | US8273379 |
| Application Is Considered Ready for Issue Critical | 28 Aug, 2012 | US8273379 |
| Issue Fee Payment Received Critical | 27 Aug, 2012 | US8273379 |
| Issue Fee Payment Verified Critical | 27 Aug, 2012 | US8273379 |
FDA has granted several exclusivities to Trisenox. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Trisenox, 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 Trisenox.
Exclusivity Information
Trisenox holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Trisenox's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE-167) | Jan 12, 2025 |
US patents provide insights into the exclusivity only within the United States, but Trisenox 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 Trisenox's family patents as well as insights into ongoing legal events on those patents.
Trisenox's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Trisenox's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 12, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Trisenox Generic API suppliers:
Arsenic Trioxide is the generic name for the brand Trisenox. 11 different companies have already filed for the generic of Trisenox, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Trisenox's generic
How can I launch a generic of Trisenox before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Trisenox's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Trisenox'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 Trisenox -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/mL | 11 Aug, 2015 | 1 | 31 Aug, 2018 | 10 Nov, 2018 | Deferred |
About Trisenox
Trisenox is a drug owned by Cephalon Inc. It is used for treating acute promyelocytic leukemia (APL) characterized by specific genetic markers and resistance to traditional chemotherapy. Trisenox uses Arsenic Trioxide as an active ingredient. Trisenox was launched by Cephalon in 2000.
Approval Date:
Trisenox was approved by FDA for market use on 25 September, 2000.
Active Ingredient:
Trisenox uses Arsenic Trioxide as the active ingredient. Check out other Drugs and Companies using Arsenic Trioxide ingredient
Treatment:
Trisenox is used for treating acute promyelocytic leukemia (APL) characterized by specific genetic markers and resistance to traditional chemotherapy.
Dosage:
Trisenox is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |
| 2MG/ML | INJECTABLE | Prescription | INJECTION |