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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-four 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

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>
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYes6,331,317<disabled>Y<disabled>
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYes6,403,114<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>
6,110,503 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent<disabled in preview>
7,300,671Method and apparatus for preparing microparticles using in-line solvent extraction<disabled in preview>
6,861,016 Apparatus and method for preparing microparticles<disabled in preview>
7,371,406Preparation of injectable suspensions having improved injectability<disabled in preview>
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International Patent Family for Tradename: VIVITROL

Country Document Number Publication Date
Portugal1282404Jul 16, 2008
Czech Republic9803591Mar 17, 1999
European Patent Office1210942May 26, 2004
Slovenia1210942Oct 31, 2007
Turkey9802258Nov 21, 2001
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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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