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.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Vivitrol US7919499 Naltrexone long acting formulations and methods of use Oct 15, 2029 Alkermes
Vivitrol US6495164 Preparation of injectable suspensions having improved injectability May 25, 2020

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

Alkermes
Vivitrol US6534092 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 US6395304 Apparatus and method for preparing microparticles Nov 12, 2019

(Expired)

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

(Expired)

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

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

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

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.

Activity Date Patent Number
Patent litigations
Petition Requesting Trial 30 Jan, 2025 US7919499
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


Naltrexone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Naltrexone:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Pharmacological and Behavioral Treatment After Bariatric Surgery Yale University NA COMPLETED
(Sep 1, 2026)
PHASE3
Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized Controlled Trial for Alcohol Use Disorder (CRAVE) VA Office of Research and Development NA RECRUITING
(Sep 1, 2026)
PHASE3
Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients Medical University of South Carolina NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1) Yale University NA COMPLETED
(Aug 1, 2026)
PHASE2, PHASE3
Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a) Yale University NA COMPLETED
(Aug 1, 2026)
PHASE2, PHASE3
Low-Dose Naltrexone For ME/CFS: Dose-Finding University of Alabama at Birmingham NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Predicting Response to Naltrexone With Eye Tracking in Gaming Disorder University of Sao Paulo NA RECRUITING
(Jul 1, 2026)
PHASE2
iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers Akyso Therapeutics, LLC NA RECRUITING
(Jul 1, 2026)
PHASE1
A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients Medical University of South Carolina NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Low-dose Naltrexone for Bladder Pain Syndrome Stanford University NA TERMINATED
(Jun 1, 2026)
PHASE2
An Innovative Intervention for OUD Treatment Johns Hopkins University NA COMPLETED
(May 1, 2026)
PHASE2, PHASE3
Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy Dartmouth-Hitchcock Medical Center NA RECRUITING
(May 1, 2026)
PHASE2
Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) Ensysce Biosciences NA RECRUITING
(May 1, 2026)
PHASE1
Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) Truway Health, Inc. NA ENROLLING BY INVITATION
(May 1, 2026)
PHASE1, PHASE2
Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol BioCorRx Pharmaceuticals Inc NA RECRUITING
(May 1, 2026)
PHASE1
Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2) Stanford University NA RECRUITING
(Apr 1, 2026)
PHASE2
Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults Akyso Therapeutics, LLC NA COMPLETED
(Apr 1, 2026)
PHASE1
Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury Medical College of Wisconsin NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Targeted Naltrexone to Support Individuals Participating in Dry January Brigham and Women's Hospital NA COMPLETED
(Apr 1, 2026)
PHASE2
Low-dose Naltrexone for Post-COVID Fatigue Syndrome Luis Nacul NA COMPLETED
(Mar 1, 2026)
PHASE2
Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury Seoul National University Hospital NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2
Combination Gerotherapeutic Interventions for Healthspan Improvement AgelessRx NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE3


Naltrexone Generic API Manufacturers

Only one generic application has been filed for Naltrexone.

Given below is the list of companies who have filed for Naltrexone generic, along with the locations of their manufacturing plants worldwide.