Tracleer is a drug owned by Actelion Pharmaceuticals Us Inc. It is protected by 3 US drug patents filed from 2013 to 2017. Out of these, 2 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 28, 2027. Details of Tracleer'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5292740 | Sulfonamides |
Nov, 2015
(8 years ago) |
Expired
|
| US8309126 | Dispersible bosentan tablet |
May, 2026
(1 year, 9 months from now) | Active |
| US7959945 | Dispersible bosentan tablet |
Dec, 2027
(3 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 Tracleer's patents.
Latest Legal Activities on Tracleer's Patents
Given below is the list of recent legal activities going on the following patents of Tracleer.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 May, 2024 | US8309126 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Nov, 2022 | US7959945 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Apr, 2020 | US8309126 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 Dec, 2018 | US7959945 |
| Filing Receipt - Corrected | 23 Sep, 2013 | US7959945 |
| Email Notification | 23 Sep, 2013 | US7959945 |
| Recordation of Patent Grant Mailed | 13 Nov, 2012 | US8309126 |
| Patent Issue Date Used in PTA Calculation | 13 Nov, 2012 | US8309126 |
| Issue Notification Mailed | 24 Oct, 2012 | US8309126 |
| Dispatch to FDC | 19 Oct, 2012 | US8309126 |
FDA has granted several exclusivities to Tracleer. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tracleer, 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 Tracleer.
Exclusivity Information
Tracleer holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Tracleer's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-607) | Aug 07, 2012 |
| New Patient Population(NPP) | Sep 05, 2020 |
| ODE*(ODE*) | Sep 05, 2024 |
US patents provide insights into the exclusivity only within the United States, but Tracleer 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 Tracleer's family patents as well as insights into ongoing legal events on those patents.
Tracleer's family patents
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Generic Launch
Generic Release Date:
Tracleer's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 28, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tracleer Generics:
Bosentan is the generic name for the brand Tracleer. 11 different companies have already filed for the generic of Tracleer, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tracleer's generic
How can I launch a generic of Tracleer before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tracleer's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tracleer'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 Tracleer -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 32 mg | 08 Feb, 2019 | 1 | 28 Dec, 2027 |
About Tracleer
Tracleer is a drug owned by Actelion Pharmaceuticals Us Inc. Tracleer uses Bosentan as an active ingredient. Tracleer was launched by Actelion in 2001.
Market Authorisation Date:
Tracleer was approved by FDA for market use on 20 November, 2001.
Active Ingredient:
Tracleer uses Bosentan as the active ingredient. Check out other Drugs and Companies using Bosentan ingredient
Dosage:
Tracleer is available in the following dosage forms - tablet, for suspension form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 62.5MG | TABLET | Prescription | ORAL |
| 125MG | TABLET | Prescription | ORAL |
| 32MG | TABLET, FOR SUSPENSION | Prescription | ORAL |