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NALOXONE HYDROCHLORIDE - Generic Drug Details

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

Naloxone hydrochloride is the generic ingredient in seven branded drugs marketed by Abraxis Pharm, Marsam Pharms Llc, Bristol Myers Squibb, Adapt, Mylan Institutional, Intl Medication, Watson Labs, Hospira, Kaleo Inc, Akorn, Smith And Nephew, Eurohlth Intl Sarl, Solopak, Astrazeneca, Igi Labs Inc, Wyeth Ayerst, West-ward Pharms Int, Purdue Pharma Lp, Sun Pharm Inds Ltd, Sanofi Aventis Us, and Gavis Pharms, and is included in sixty-three NDAs. There are forty-seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and thirty-six patent family members in seventeen countries.

There are twelve drug master file entries for naloxone hydrochloride. Sixteen suppliers are listed for this compound.

Summary for Generic Name: NALOXONE HYDROCHLORIDE

Tradenames:7
Patents:48
Applicants:21
NDAs:63
Drug Master File Entries: see list12
Suppliers / Packagers: see list16
Bulk Api Vendors: see list49
Clinical Trials: see list1,074
Patent Applications: see list6,006
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:NALOXONE HYDROCHLORIDE at DailyMed

Pharmacology for Ingredient: NALOXONE HYDROCHLORIDE

Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-003Jul 23, 2014DISCNNoNo9,283,216► SubscribeY ► Subscribe
Igi Labs Inc
NALOXONE HYDROCHLORIDE
naloxone hydrochloride
INJECTABLE;INJECTION072088-001Apr 11, 1989DISCNNoNo► Subscribe► Subscribe
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-003Jul 23, 2014DISCNNoNo9,168,252► SubscribeY ► Subscribe
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-003Jul 23, 2014DISCNNoNo9,073,933► SubscribeY ► Subscribe
Bristol Myers Squibb
NARCAN
naloxone hydrochloride
INJECTABLE;INJECTION071083-001Jul 28, 1988DISCNNoNo► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: naloxone hydrochloride

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
9,084,849Medicament delivery devices for administration of a medicament within a prefilled syringe► Subscribe
9,555,191Apparatus and methods for self-administration of vaccines and other medicaments► Subscribe
7,648,483Devices, systems and methods for medicament delivery► Subscribe
8,932,252Medical injector simulation device► Subscribe
8,123,719Devices, systems and methods for medicament delivery► 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: naloxone hydrochloride

Country Document Number Estimated Expiration
United Kingdom0905194► Subscribe
European Patent Office2667926► Subscribe
United Kingdom201108993► Subscribe
Australia2015228541► Subscribe
United Kingdom0713202► 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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Supplementary Protection Certificates for Tradename: NALOXONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
292Luxembourg► SubscribePRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
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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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