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Naloxone hydrochloride; oxycodone hydrochloride - Generic Drug Details

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Naloxone hydrochloride; oxycodone hydrochloride is the generic ingredient in one branded drug marketed by Purdue Pharma Lp and is included in one NDA. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and forty-eight patent family members in forty-four countries.

There are twelve drug master file entries for naloxone hydrochloride; oxycodone hydrochloride.

Summary for Generic Name: naloxone hydrochloride; oxycodone hydrochloride

Tradenames:1
Patents:20
Applicants:1
NDAs:1
Drug Master File Entries: see list12
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-001Jul 23, 2014DISCNNo8,673,355► subscribeY ► subscribe
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-003Jul 23, 2014DISCNNo7,674,800► subscribeY ► subscribe
Purdue Pharma Lp
TARGINIQ
naloxone hydrochloride; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL205777-001Jul 23, 2014DISCNNo► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: naloxone hydrochloride; oxycodone 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
6,375,957 Opioid agonist/opioid antagonist/acetaminophen combinations► subscribe
8,936,808Opioid agonist/opioid antagonist/acetaminophen combinations► subscribe
7,749,542Opioid agonist/antagonist combinations► 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; oxycodone hydrochloride

Country Document Number Estimated Expiration
Slovenia2319846► subscribe
Hungary0102658► subscribe
TaiwanI345973► 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; OXYCODONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00052Denmark► subscribePRODUCT NAME: KOMBINATION AF OXYCODON SOM KOMPONENT A OG NALOXON SOM KOMPONENT B, HERUNDER OXYCODONHYDROCHLORID OG NALOXONHYDROCHLORIDDIHYDRAT; NAT. REG. NO/DATE: 43673, 43674 20081117; FIRST REG. NO/DATE: DE 64537.00.00, 64538.00.00, 64540.00.00, 64541.00.00 20060530
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
00619Netherlands► subscribePRODUCT NAME: EEN COMBINATIE VAN OXYCODON ALS COMPONENT A EN NALOXON ALS COMPONENT B IN ALLE VORMEN ZOALS DEZE DOOR HET BASIS OCTROOI ONDER BESCHERMING WORDEN GESTELD; REGISTRATION NO/DATE: 64537.00.00 64538.00.00 64540.00.00 64541.00.00 20060530
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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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