Desyrel is a drug owned by Pragma Pharmaceuticals Llc. It is protected by 1 US drug patent filed in 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 13, 2029. Details of Desyrel'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. | |||
| US8133893 | Trazodone and trazodone hydrochloride in purified form |
Mar, 2029
(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 Desyrel's patents.
Latest Legal Activities on Desyrel's Patents
Given below is the list of recent legal activities going on the following patents of Desyrel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Sep, 2023 | US8133893 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Sep, 2019 | US8133893 |
| Post Issue Communication - Certificate of Correction | 13 Aug, 2012 | US8133893 |
| Patent Issue Date Used in PTA Calculation Critical | 13 Mar, 2012 | US8133893 |
| Recordation of Patent Grant Mailed Critical | 13 Mar, 2012 | US8133893 |
| Email Notification Critical | 23 Feb, 2012 | US8133893 |
| Issue Notification Mailed Critical | 22 Feb, 2012 | US8133893 |
| Dispatch to FDC | 09 Feb, 2012 | US8133893 |
| Printer Rush- No mailing | 01 Feb, 2012 | US8133893 |
| Pubs Case Remand to TC Critical | 31 Jan, 2012 | US8133893 |
US patents provide insights into the exclusivity only within the United States, but Desyrel 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 Desyrel's family patents as well as insights into ongoing legal events on those patents.
Desyrel's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Desyrel's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 13, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Desyrel Generic API suppliers:
Trazodone Hydrochloride is the generic name for the brand Desyrel. 23 different companies have already filed for the generic of Desyrel, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Desyrel's generic
How can I launch a generic of Desyrel before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Desyrel's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Desyrel'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 Desyrel -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg |
Alternative Brands for Desyrel
There are several other brand drugs using the same active ingredient (Trazodone Hydrochloride) as Desyrel. 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Trazodone Hydrochloride, Desyrel's active ingredient. Check the complete list of approved generic manufacturers for Desyrel
About Desyrel
Desyrel is a drug owned by Pragma Pharmaceuticals Llc. Desyrel uses Trazodone Hydrochloride as an active ingredient. Desyrel was launched by Pragma in 1982.
Approval Date:
Desyrel was approved by FDA for market use on 01 January, 1982.
Active Ingredient:
Desyrel uses Trazodone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Trazodone Hydrochloride ingredient
Dosage:
Desyrel is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |