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Profile for Tradename: VIVITROL

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Vivitrol is a drug marketed by Alkermes and is included in one NDA. It is available from one supplier. There are nineteen patents protecting this drug.

This drug has one hundred and forty-five patent family members in thirty-three countries.

The generic ingredient in VIVITROL is naltrexone. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the naltrexone profile page.

Summary for Tradename: VIVITROL

Patents:19
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Clinical Trials for: VIVITROL

ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
Status: Completed Condition: Alcohol Dependence

Improved Strategies for Outpatient Opioid Detoxification
Status: Recruiting Condition: Opioid Dependence

VIVITROL as a Treatment for Cocaine and Alcohol Dependence
Status: Completed Condition: Cocaine Dependence; Alcohol Dependence

A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Status: Completed Condition: Opioid Dependence

ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
Status: Completed Condition: Opiate Dependence

Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland
Status: Completed Condition: Amphetamine Dependence

Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
Status: Completed Condition: Opiate Dependence

ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults
Status: Completed Condition: Alcohol Dependence

Pre-Release VIVITROL for Opioid Dependent Inmates
Status: Completed Condition: Substance-Related Disorders

Memantine as a Supplement to Naltrexone in Treating Heroin Dependence
Status: Completed Condition: Opioid Dependence; Heroin Dependence

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYes7,919,499<disabled> <disabled>
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYes6,495,166<disabled>Y <disabled>
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYes6,395,304<disabled>Y <disabled>
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Non-Orange Book Patents for Tradename: VIVITROL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,540,393 Apparatus for preparing microparticles using in-line solvent extraction<disabled in preview>
7,371,406Preparation of injectable suspensions having improved injectability<disabled in preview>
6,110,503 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent<disabled in preview>
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International Patent Family for Tradename: VIVITROL

Country Document Number Publication Date
Poland365195Dec 27, 2004
World Intellectual Property Organization (WIPO)0134120Dec 20, 2001
Cyprus2318Nov 14, 2003
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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