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VIVITROL Drug Profile

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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-eight patent family members in thirty-three countries.

The generic ingredient in VIVITROL is naltrexone. There are seventeen 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 list1
Drug Prices: :see details

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, 2006RXYes7,919,499Oct 15, 2029
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYes6,495,166Nov 12, 2019Y
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYes6,395,304Nov 12, 2019Y
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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
6,110,503 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>
7,510,730Apparatus and method for preparing microparticles using in-line solvent extraction<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: VIVITROL

Country Document Number Estimated Expiration
South Korea100432677<disabled in preview>
Hungary9902797<disabled in preview>
China100453067<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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