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Naltrexone - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for naltrexone?

Naltrexone is the generic ingredient in four branded drugs marketed by Alkermes, Accord Hlthcare, Barr, Teva Womens, Sandoz, Sun Pharma Global, Mallinckrodt, Elite Labs, and Pfizer Inc, and is included in nine NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and forty-nine patent family members in thirty-three countries.

There are eighteen drug master file entries for naltrexone. One supplier is listed for this compound.

Summary for Generic Name: naltrexone

Tradenames:4
Patents:22
Applicants:9
NDAs:9
Drug Master File Entries: see list18
Suppliers / Packagers: see list1
Bulk Api Vendors: see list25
Clinical Trials: see list153
Patent Applications: see list5,554
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:naltrexone at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Inc
TROXYCA ER
naltrexone hydrochloride; oxycodone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL207621-001Aug 19, 2016RXNoNo8,685,443► Subscribe ► Subscribe
Pfizer Inc
TROXYCA ER
naltrexone hydrochloride; oxycodone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL207621-003Aug 19, 2016RXNoNo7,815,934► SubscribeY ► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYesYes6,939,033► SubscribeY ► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYesYes6,713,090► SubscribeY ► Subscribe
Pfizer Inc
TROXYCA ER
naltrexone hydrochloride; oxycodone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL207621-004Aug 19, 2016RXNoNo7,815,934► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: naltrexone

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► Subscribe
7,510,730Apparatus and method for preparing microparticles using in-line solvent extraction► Subscribe
6,705,757 Method and apparatus for preparing microparticles using in-line solvent extraction► Subscribe
6,540,393 Apparatus for preparing microparticles using in-line solvent extraction► Subscribe
6,290,983 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent► Subscribe
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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 Ingredient: naltrexone

Country Document Number Estimated Expiration
South Korea20090050111► Subscribe
Spain2391315► Subscribe
Spain2183172► Subscribe
Spain2574823► Subscribe
Australia759214► Subscribe
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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.

Export unavailable in trial.
Subscribe for complete access.

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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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