Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Mallinckrodt
McKesson
Fuji
Queensland Health
Federal Trade Commission
Argus Health
Fish and Richardson
Julphar
Johnson and Johnson

Generated: October 21, 2017

DrugPatentWatch Database Preview

NALOXONE HYDROCHLORIDE - Generic Drug Details

« Back to Dashboard

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 Abraxis Pharm, Marsam Pharms Llc, Bristol Myers Squibb, Adapt, Mylan Institutional, Intl Medication, Somerset Theraps Llc, 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-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. Sixteen suppliers are listed for this compound.

Summary for Generic Name: NALOXONE HYDROCHLORIDE

US Patents:52
Tradenames:7
Applicants:22
NDAs:65
Drug Master File Entries: see list12
Suppliers / Packagers: see list16
Bulk Api Vendors: see list49
Clinical Trials: see list2,501
Patent Applications: see list6,617
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-001Jul 23, 2014DISCNNoNo► Subscribe► Subscribe► Subscribe
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-001Jul 23, 2014DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Kaleo Inc
EVZIO
naloxone hydrochloride
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS205787-001Apr 3, 2014DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Kaleo Inc
EVZIO
naloxone hydrochloride
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS205787-001Apr 3, 2014DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-001Jul 23, 2014DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Kaleo Inc
EVZIO
naloxone hydrochloride
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS205787-001Apr 3, 2014DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Kaleo Inc
EVZIO
naloxone hydrochloride
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS205787-001Apr 3, 2014DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Bristol Myers Squibb
NARCAN
naloxone hydrochloride
INJECTABLE;INJECTION071311-001Jul 28, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-002Jul 23, 2014DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-001Jul 23, 2014DISCNNoNo► Subscribe► SubscribeY ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
7,648,483Devices, systems and methods for medicament delivery► Subscribe
9,022,980Medical injector simulation device► Subscribe
8,920,377Devices, systems and methods for medicament delivery► Subscribe
8,899,987Simulated medicament delivery device having an electronic circuit system► Subscribe
9,259,539Devices, systems and methods for medicament delivery► Subscribe
9,084,849Medicament delivery devices for administration of a medicament within a prefilled syringe► Subscribe
8,172,082Devices, systems and methods for medicament delivery► Subscribe
9,555,191Apparatus and methods for self-administration of vaccines and other medicaments► Subscribe
9,278,177Medical injector with compliance tracking and monitoring► Subscribe
8,920,367Devices, systems and methods for medicament delivery► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: naloxone hydrochloride

Country Document Number Estimated Expiration
New Zealand589864► Subscribe
Mexico2007005946► Subscribe
Japan2017508800► Subscribe
United Kingdom2451769► Subscribe
United Kingdom2453069► Subscribe
Germany112015001251► Subscribe
Japan5599500► Subscribe
United Kingdom2458586► Subscribe
China103492019► Subscribe
Singapore11201607281P► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
UBS
Express Scripts
Queensland Health
Cerilliant
Moodys
Argus Health
US Department of Justice
Chubb
Deloitte

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot