Naltrexone Patent Expiration

Naltrexone is Used for treating alcohol dependence. It was first introduced by Alkermes Inc in its drug Vivitrol on Apr 13, 2006. 2 different companies have introduced drugs containing Naltrexone.


Naltrexone Patents

Given below is the list of patents protecting Naltrexone, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Vivitrol US5792477 Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent May 02, 2017

(Expired)

Alkermes
Vivitrol US5916598 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent May 02, 2017

(Expired)

Alkermes
Vivitrol US6194006 Preparation of microparticles having a selected release profile Dec 30, 2018

(Expired)

Alkermes
Vivitrol US6264987 Method for preparing microparticles having a selected polymer molecular weight May 19, 2020

(Expired)

Alkermes
Vivitrol US6331317 Apparatus and method for preparing microparticles Nov 12, 2019

(Expired)

Alkermes
Vivitrol US6379703 Preparation of microparticles having a selected release profile Dec 30, 2018

(Expired)

Alkermes
Vivitrol US6379704 Method for preparing microparticles having a selected polymer molecular weight May 19, 2020

(Expired)

Alkermes
Vivitrol US6395304 Apparatus and method for preparing microparticles Nov 12, 2019

(Expired)

Alkermes
Vivitrol US6403114 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent May 02, 2017

(Expired)

Alkermes
Vivitrol US6495164 Preparation of injectable suspensions having improved injectability May 25, 2020

(Expired)

Alkermes
Vivitrol US6495166 Apparatus and method for preparing microparticles using in-line solvent extraction Nov 12, 2019

(Expired)

Alkermes
Vivitrol US6534092 Method for preparing microparticles having a selected polymer molecular weight May 19, 2020

(Expired)

Alkermes
Vivitrol US6537586 Apparatus and method for preparing microparticles Nov 12, 2019

(Expired)

Alkermes
Vivitrol US6596316 Preparation of microparticles having a selected release profile Dec 30, 2018

(Expired)

Alkermes
Vivitrol US6667061 Preparation of injectable suspensions having improved injectability May 25, 2020

(Expired)

Alkermes
Vivitrol US6713090 Apparatus and method for preparing microparticles Nov 12, 2019

(Expired)

Alkermes
Vivitrol US6939033 Method and apparatus for preparing microparticles using in-line solvent extraction Nov 12, 2019

(Expired)

Alkermes
Vivitrol US7799345 Preparation of injectable suspensions having improved injectability May 25, 2020

(Expired)

Alkermes
Vivitrol US7919499 Naltrexone long acting formulations and methods of use Oct 15, 2029 Alkermes


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 Naltrexone's patents.

Given below is the list recent legal activities going on the following patents of Naltrexone.

Event Date Patent/Publication
Patent litigations
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 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 05 Apr, 2011 US7919499
Recordation of Patent Grant Mailed 05 Apr, 2011 US7919499
Email Notification 17 Mar, 2011 US7919499



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Naltrexone Generics

Only one generic application has been filed for Naltrexone.

Given below is the list of companies who have filed for Naltrexone generic.


1. TEVA PHARMS USA INC

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Naltrexone. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
380MG/VIAL for suspension, extended release Discontinued INTRAMUSCULAR N/A Jul 6, 2023