Vivitrol is a drug owned by Alkermes Inc. It is protected by 19 US drug patents filed in 2013. Out of these, 1 drug patents are active and 18 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 15, 2029. Details of Vivitrol'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). | |||
| US7919499 | Naltrexone long acting formulations and methods of use |
Oct, 2029
(4 years from now) | Active |
| US6495164 | Preparation of injectable suspensions having improved injectability |
May, 2020
(4 years ago) |
Expired
|
| US7799345 | Preparation of injectable suspensions having improved injectability |
May, 2020
(4 years ago) |
Expired
|
| US6667061 | Preparation of injectable suspensions having improved injectability |
May, 2020
(4 years ago) |
Expired
|
| US6264987 | Method for preparing microparticles having a selected polymer molecular weight |
May, 2020
(4 years ago) |
Expired
|
| US6379704 | Method for preparing microparticles having a selected polymer molecular weight |
May, 2020
(4 years ago) |
Expired
|
| US6534092 | Method for preparing microparticles having a selected polymer molecular weight |
May, 2020
(4 years ago) |
Expired
|
| US6537586 | Apparatus and method for preparing microparticles |
Nov, 2019
(4 years ago) |
Expired
|
| US6939033 | Method and apparatus for preparing microparticles using in-line solvent extraction |
Nov, 2019
(4 years ago) |
Expired
|
| US6395304 | Apparatus and method for preparing microparticles |
Nov, 2019
(4 years ago) |
Expired
|
| US6495166 | Apparatus and method for preparing microparticles using in-line solvent extraction |
Nov, 2019
(4 years ago) |
Expired
|
| US6331317 | Apparatus and method for preparing microparticles |
Nov, 2019
(4 years ago) |
Expired
|
| US6713090 | Apparatus and method for preparing microparticles |
Nov, 2019
(4 years ago) |
Expired
|
| US6194006 | Preparation of microparticles having a selected release profile |
Dec, 2018
(5 years ago) |
Expired
|
| US6596316 | Preparation of microparticles having a selected release profile |
Dec, 2018
(5 years ago) |
Expired
|
| US6379703 | Preparation of microparticles having a selected release profile |
Dec, 2018
(5 years ago) |
Expired
|
| US6403114 | Preparation of biodegradable, biocompatible microparticles containing a biologically active agent |
May, 2017
(7 years ago) |
Expired
|
| US5792477 | Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent |
May, 2017
(7 years ago) |
Expired
|
| US5916598 | Preparation of biodegradable, biocompatible microparticles containing a biologically active agent |
May, 2017
(7 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 Vivitrol's patents.
Latest Legal Activities on Vivitrol's Patents
Given below is the list of recent legal activities going on the following patents of Vivitrol.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Oct, 2022 | US7919499 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Mar, 2022 | US7799345 |
| Termination or Final Written Decision | 31 Jul, 2019 | US7919499 |
| Request for Trial Granted Critical | 07 Nov, 2018 | US7919499 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Oct, 2018 | US7919499 |
| Petition Requesting Trial | 20 Apr, 2018 | US7919499 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Mar, 2018 | US7799345 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Apr, 2011 | US7919499 |
| Recordation of Patent Grant Mailed Critical | 05 Apr, 2011 | US7919499 |
| Email Notification Critical | 17 Mar, 2011 | US7919499 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Vivitrol and ongoing litigations to help you estimate the early arrival of Vivitrol generic.
Vivitrol's Litigations
Vivitrol been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 31, 2016, against patent number US6667061. The petitioner Luye Pharma Group Ltd., challenged the validity of this patent, with Alkermes Controlled Therapeutics, Inc. as the respondent. Click below to track the latest information on how companies are challenging Vivitrol's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7919499 | April, 2018 |
Terminated-Settled
(31 Jul, 2019) | Alkermes Pharma Ireland Limited | Amneal Pharmaceuticals LLC |
| US6667061 | May, 2016 |
FWD Entered
(28 Nov, 2017) | Alkermes Controlled Therapeutics, Inc. | Luye Pharma Group Ltd. |
| US6667061 | May, 2016 |
Terminated-Denied
(30 Nov, 2016) | Alkermes Controlled Therapeutics, Inc. | Luye Pharma Group Ltd. |
FDA has granted some exclusivities to Vivitrol. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vivitrol, 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 Vivitrol.
Exclusivity Information
Vivitrol holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Vivitrol's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-631) | Oct 12, 2013 |
US patents provide insights into the exclusivity only within the United States, but Vivitrol 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 Vivitrol's family patents as well as insights into ongoing legal events on those patents.
Vivitrol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vivitrol's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 15, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vivitrol Generic API suppliers:
Naltrexone is the generic name for the brand Vivitrol. 1 company has already filed for the generic of Vivitrol. Check out the entire list of companies who have already received approval for Vivitrol's generic
How can I launch a generic of Vivitrol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vivitrol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vivitrol'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 Vivitrol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 380 mg/vial | 18 Jun, 2020 | 1 | 06 Jul, 2023 | 15 Oct, 2029 | Deferred |
Alternative Brands for Vivitrol
Vivitrol which is used for treating alcohol dependence., has several other brand drugs using the same active ingredient (Naltrexone). 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 | |
|---|---|---|
| Alpharma Pharms |
| |
| Nalpropion |
| |
| Pfizer |
| |
| Salix |
| |
| Salix Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Naltrexone, Vivitrol's active ingredient. Check the complete list of approved generic manufacturers for Vivitrol
About Vivitrol
Vivitrol is a drug owned by Alkermes Inc. It is used for treating alcohol dependence. Vivitrol uses Naltrexone as an active ingredient. Vivitrol was launched by Alkermes in 2006.
Approval Date:
Vivitrol was approved by FDA for market use on 13 April, 2006.
Active Ingredient:
Vivitrol uses Naltrexone as the active ingredient. Check out other Drugs and Companies using Naltrexone ingredient
Treatment:
Vivitrol is used for treating alcohol dependence.
Dosage:
Vivitrol is available in for suspension, extended release form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 380MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |