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Generated: May 25, 2017

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Naltrexone hydrochloride - Generic Drug Details

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

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

There are eighteen drug master file entries for naltrexone hydrochloride. Sixteen suppliers are listed for this compound.

Summary for Generic Name: naltrexone hydrochloride

Drug Master File Entries: see list18
Suppliers / Packagers: see list16
Bulk Api Vendors: see list42
Clinical Trials: see list1,127
Patent Applications: see list766
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:naltrexone hydrochloride at DailyMed

Pharmacology for Ingredient: naltrexone hydrochloride

Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Inc
naltrexone hydrochloride; oxycodone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL207621-002Aug 19, 2016RXNoNo8,685,443► Subscribe ► Subscribe
Sun Pharma Global
naltrexone hydrochloride
TABLET;ORAL090356-001Feb 24, 2012ABRXNoNo► Subscribe► Subscribe
Pfizer Inc
naltrexone hydrochloride; oxycodone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL207621-002Aug 19, 2016RXNoNo► Subscribe► Subscribe
Teva Womens
naltrexone hydrochloride
TABLET;ORAL018932-001Nov 20, 1984DISCNNoNo► Subscribe► Subscribe
Pfizer Inc
naltrexone hydrochloride; oxycodone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL207621-003Aug 19, 2016RXNoNo8,685,443► Subscribe ► Subscribe
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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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