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Serving 500+ biopharmaceutical companies globally:

Cerilliant
UBS
Johnson and Johnson
Cipla
Express Scripts
QuintilesIMS
Medtronic
Julphar
Accenture
Queensland Health

Generated: August 17, 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, 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.

Naltrexone has one hundred and fifty-three 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:21
Applicants:9
NDAs:9
Drug Master File Entries: see list18
Suppliers / Packagers: see list1
Bulk Api Vendors: see list25
Clinical Trials: see list333
Patent Applications: see list9,118
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
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
Barr
NALTREXONE HYDROCHLORIDE
naltrexone hydrochloride
TABLET;ORAL074918-001May 8, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe
Elite Labs
NALTREXONE HYDROCHLORIDE
naltrexone hydrochloride
TABLET;ORAL075274-001May 26, 1999ABRXNoNo► Subscribe► Subscribe► 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
6,540,393 Apparatus for preparing microparticles using in-line solvent extraction► Subscribe
6,861,016 Apparatus and method for preparing microparticles► Subscribe
6,290,983 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent► Subscribe
7,371,406Preparation of injectable suspensions having improved injectability► Subscribe
6,705,757 Method and apparatus for preparing microparticles using in-line solvent extraction► 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 Africa200608563► Subscribe
Spain2574823► Subscribe
World Intellectual Property Organization (WIPO)0134113► Subscribe
Cyprus1110403► Subscribe
Australia3117800► 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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Serving 500+ biopharmaceutical companies globally:

Argus Health
Fuji
Cerilliant
Dow
Healthtrust
Federal Trade Commission
McKinsey
Cipla
Harvard Business School
Accenture

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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