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Serving leading biopharmaceutical companies globally:

Baxter
Chubb
Chinese Patent Office
Daiichi Sankyo
Cerilliant
Citi
Express Scripts
Cantor Fitzgerald
Fuji
AstraZeneca

Generated: October 20, 2017

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Naltrexone - Generic Drug Details

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What are the generic sources for naltrexone and what is the scope of naltrexone freedom to operate?

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

Naltrexone has one hundred and seventy-eight patent family members in thirty-three countries.

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

Summary for Generic Name: naltrexone

US Patents:21
Tradenames:4
Applicants:10
NDAs:10
Drug Master File Entries: see list19
Suppliers / Packagers: see list1
Bulk Api Vendors: see list25
Clinical Trials: see list338
Patent Applications: see list6,354
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:naltrexone at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Pfizer Inc
TROXYCA ER
naltrexone hydrochloride; oxycodone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL207621-004Aug 19, 2016RXNoNo► Subscribe► Subscribe ► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Pfizer Inc
TROXYCA ER
naltrexone hydrochloride; oxycodone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL207621-003Aug 19, 2016RXNoNo► Subscribe► Subscribe ► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: naltrexone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006► Subscribe► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006► Subscribe► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006► Subscribe► Subscribe
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006► Subscribe► 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
7,510,730Apparatus and method for preparing microparticles using in-line solvent extraction► Subscribe
6,290,983 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent► Subscribe
6,540,393 Apparatus for preparing microparticles using in-line solvent extraction► Subscribe
6,861,016 Apparatus and method for preparing microparticles► Subscribe
6,110,503 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent► Subscribe
7,300,671Method and apparatus for preparing microparticles using in-line solvent extraction► Subscribe
6,705,757 Method and apparatus for preparing microparticles using in-line solvent extraction► Subscribe
7,371,406Preparation of injectable suspensions having improved injectability► 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
Czech Republic293578► Subscribe
Japan2003534366► Subscribe
European Patent Office1242053► Subscribe
Japan4694694► Subscribe
Japan2000503663► Subscribe
Portugal904063► Subscribe
Poland365195► Subscribe
Denmark2269577► Subscribe
China1224380► Subscribe
European Patent Office3095442► 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.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Medtronic
Dow
Daiichi Sankyo
Cerilliant
Chinese Patent Office
Express Scripts
Fuji
Boehringer Ingelheim
Healthtrust

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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