Oleptro is a drug owned by Angelini Pharma Inc. It is protected by 3 US drug patents filed in 2013. 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 Mar 13, 2029. Details of Oleptro'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
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7829120 | Trazodone composition for once a day administration |
Mar, 2027
(2 years from now) | Active |
| US6607748 | Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture |
Jun, 2020
(4 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 Oleptro's patents.
Latest Legal Activities on Oleptro's Patents
Given below is the list of recent legal activities going on the following patents of Oleptro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Sep, 2023 | US8133893 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 May, 2022 | US7829120 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Sep, 2019 | US8133893 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Apr, 2018 | US7829120 |
| 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 |
FDA has granted several exclusivities to Oleptro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Oleptro, 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 Oleptro.
Exclusivity Information
Oleptro holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Oleptro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Feb 02, 2013 |
US patents provide insights into the exclusivity only within the United States, but Oleptro 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 Oleptro's family patents as well as insights into ongoing legal events on those patents.
Oleptro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Oleptro's generic launch date based on the last expiry date of its patents and exclusivities combined 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)
Oleptro Generic API suppliers:
Trazodone Hydrochloride is the generic name for the brand Oleptro. 23 different companies have already filed for the generic of Oleptro, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Oleptro's generic
How can I launch a generic of Oleptro before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Oleptro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Oleptro'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 Oleptro -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg and 300 mg | 18 Oct, 2010 | 1 | 29 Jun, 2020 | Extinguished |
Alternative Brands for Oleptro
Oleptro which is used for treating depression., has several other brand drugs using the same active ingredient (Trazodone Hydrochloride). 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 | |
|---|---|---|
| Pragma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Trazodone Hydrochloride, Oleptro's active ingredient. Check the complete list of approved generic manufacturers for Oleptro
About Oleptro
Oleptro is a drug owned by Angelini Pharma Inc. It is used for treating depression. Oleptro uses Trazodone Hydrochloride as an active ingredient. Oleptro was launched by Angelini Pharma in 2010.
Approval Date:
Oleptro was approved by FDA for market use on 02 February, 2010.
Active Ingredient:
Oleptro uses Trazodone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Trazodone Hydrochloride ingredient
Treatment:
Oleptro is used for treating depression.
Dosage:
Oleptro is available in tablet, extended release 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, EXTENDED RELEASE | Discontinued | ORAL |
| 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |