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Last Updated: May 24, 2024

Naltrexone hydrochloride; oxycodone hydrochloride - Generic Drug Details


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

Naltrexone hydrochloride; oxycodone hydrochloride is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naltrexone hydrochloride; oxycodone hydrochloride has sixteen patent family members in twelve countries.

Summary for naltrexone hydrochloride; oxycodone hydrochloride
International Patents:16
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 18
DailyMed Link:naltrexone hydrochloride; oxycodone hydrochloride at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for naltrexone hydrochloride; oxycodone hydrochloride
Generic Entry Date for naltrexone hydrochloride; oxycodone hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for naltrexone hydrochloride; oxycodone hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Quotient SciencesPhase 1
Clinilabs, Inc.Phase 1/Phase 2
New York State Psychiatric InstitutePhase 1/Phase 2

See all naltrexone hydrochloride; oxycodone hydrochloride clinical trials

US Patents and Regulatory Information for naltrexone hydrochloride; oxycodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-003 Aug 19, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-002 Aug 19, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-001 Aug 19, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-006 Aug 19, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-002 Aug 19, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-003 Aug 19, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for naltrexone hydrochloride; oxycodone hydrochloride

Country Patent Number Title Estimated Expiration
Canada 2499550 SOUS-UNITE DE SEQUESTRATION ET COMPOSITIONS ET PROCEDES ASSOCIES (SEQUESTERING SUBUNIT AND RELATED COMPOSITIONS AND METHODS) ⤷  Sign Up
European Patent Office 2422772 Séquestration de sous-unité et compositions et procédés associés (Sequestering subunit and related compositions and methods) ⤷  Sign Up
Australia 2009251081 Sequestering subunit and related compositions and methods ⤷  Sign Up
Norway 20051855 ⤷  Sign Up
Australia 2003270778 SEQUESTERING SUBUNIT AND RELATED COMPOSITIONS AND METOHDS ⤷  Sign Up
Slovenia 1551372 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for naltrexone hydrochloride; oxycodone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 2017/059 Ireland ⤷  Sign Up PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456 1790064-8 Sweden ⤷  Sign Up PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330
2316456 LUC00054 Luxembourg ⤷  Sign Up PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456 17C1058 France ⤷  Sign Up PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456 132017000142109 Italy ⤷  Sign Up PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456 SPC/GB17/078 United Kingdom ⤷  Sign Up PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.