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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Covington
Express Scripts
Merck
Daiichi Sankyo
Farmers Insurance
Teva
Federal Trade Commission
US Army

Generated: December 17, 2017

DrugPatentWatch Database Preview

NALOXONE HYDROCHLORIDE - Generic Drug Details

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

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

Naloxone hydrochloride has one hundred and forty-eight patent family members in seventeen countries and one supplementary protection certificate in one country.

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

Pharmacology for NALOXONE HYDROCHLORIDE

Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

Medical Subject Heading (MeSH) Categories for NALOXONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma LpTARGINIQnaloxone hydrochloride; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL205777-003Jul 23, 2014DISCNYesNo► Subscribe► SubscribeY► Subscribe
Kaleo IncEVZIOnaloxone hydrochlorideSOLUTION;INTRAMUSCULAR, SUBCUTANEOUS209862-001Oct 19, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Purdue Pharma LpTARGINIQnaloxone hydrochloride; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL205777-003Jul 23, 2014DISCNYesNo► Subscribe► SubscribeY► Subscribe
Somerset Theraps LlcNALOXONE HYDROCHLORIDEnaloxone hydrochlorideINJECTABLE;INJECTION207633-001Aug 8, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
AdaptNARCANnaloxone hydrochlorideINJECTABLE;INJECTION016636-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Kaleo IncEVZIOnaloxone hydrochlorideSOLUTION;INTRAMUSCULAR, SUBCUTANEOUS209862-001Oct 19, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Purdue Pharma LpTARGINIQnaloxone hydrochloride; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL205777-002Jul 23, 2014DISCNYesNo► Subscribe► SubscribeY► Subscribe
Kaleo IncEVZIOnaloxone hydrochlorideSOLUTION;INTRAMUSCULAR, SUBCUTANEOUS209862-001Oct 19, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Smith And NephewNALOXONE HYDROCHLORIDEnaloxone hydrochlorideINJECTABLE;INJECTION071682-001Nov 17, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Kaleo IncEVZIOnaloxone hydrochlorideSOLUTION;INTRAMUSCULAR, SUBCUTANEOUS209862-001Oct 19, 2016RXYesYes► Subscribe► SubscribeY► 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
9,259,539Devices, systems and methods for medicament delivery► Subscribe
9,022,980Medical injector simulation device► Subscribe
8,123,719Devices, systems and methods for medicament delivery► Subscribe
9,327,077Medical injector with compliance tracking and monitoring► Subscribe
8,920,377Devices, systems and methods for medicament delivery► Subscribe
8,690,827Devices, systems, and methods for medicament delivery► Subscribe
9,084,849Medicament delivery devices for administration of a medicament within a prefilled syringe► Subscribe
9,814,838Medicament delivery device for administration of opioid antagonists including formulations for naloxone► Subscribe
9,555,191Apparatus and methods for self-administration of vaccines and other medicaments► Subscribe
8,172,082Devices, 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
European Patent Office2125075► Subscribe
China106163499► Subscribe
United Kingdom2456245► Subscribe
China101438327► Subscribe
New Zealand589864► Subscribe
Canada2926365► Subscribe
Japan2008520339► Subscribe
European Patent Office2058020► Subscribe
Japan4960252► Subscribe
World Intellectual Property Organization (WIPO)2009140251► 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Healthtrust
Cipla
UBS
Queensland Health
Cerilliant
US Department of Justice
Moodys
Medtronic
Chubb

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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