Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
McKinsey
Mallinckrodt
Colorcon
Baxter

Last Updated: October 5, 2022

Naltrexone - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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

Naltrexone is the generic ingredient in four branded drugs marketed by Alkermes, Accord Hlthcare, Barr, Chartwell, Elite Labs, Fosun Pharma, Specgx Llc, Sun Pharm, Teva Womens, and Pfizer, and is included in ten NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naltrexone has eighteen patent family members in eleven countries.

There are nineteen drug master file entries for naltrexone. One supplier is listed for this compound.

Drug Prices for naltrexone

See drug prices for naltrexone

Drug Sales Revenue Trends for naltrexone

See drug sales revenues for naltrexone

Recent Clinical Trials for naltrexone

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

SponsorPhase
Baylor College of MedicinePhase 3
Go Medical Industries Pty LtdPhase 2
University at BuffaloPhase 2

See all naltrexone clinical trials

Medical Subject Heading (MeSH) Categories for naltrexone
Paragraph IV (Patent) Challenges for NALTREXONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VIVITROL Extended-release Injectable Suspension naltrexone 380 mg/vial 021897 1 2020-06-18

US Patents and Regulatory Information for naltrexone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 091205-001 Aug 17, 2011 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-006 Aug 19, 2016 DISCN No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Specgx Llc NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 076264-002 Mar 22, 2002 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-002 Aug 19, 2016 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Elite Labs NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 075274-001 May 26, 1999 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 076264-001 Mar 22, 2002 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-001 Aug 19, 2016 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for naltrexone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for naltrexone

Country Patent Number Title Estimated Expiration
Canada 2563086 PROCEDE ET SYSTEME D'INVESTIGATION ANONYME ETENDUE BASEE SURDES FAITS ET D'ETABLISSEMENT DE RAPPORTS A BASE DE FAITS ET D'ACCES SELECTIF AUX RESULTATS ET RAPPORTS (NALTREXONE LONG ACTING FORMULATIONS AND METHODS OF USE) See Plans and Pricing
South Africa 200608563 Naltrexone long acting formulations and methods of use See Plans and Pricing
Japan 2011225600 NALTREXONE LONG ACTING FORMULATION AND METHOD OF USE See Plans and Pricing
China 1946353 Naltrexone long acting formulations and methods of use See Plans and Pricing
European Patent Office 1740120 COMPOSITIONS DE NALTREXONE, À ACTION LONGUE DURÉE ET MÉTHODE D'UTILISATION (NALTREXONE LONG ACTING FORMULATIONS AND METHODS OF USE) See Plans and Pricing
United Kingdom 2398895 Real time trading involving financial instruments See Plans and Pricing
Russian Federation 2006137349 КОМПОЗИЦИИ ПРОДОЛЖИТЕЛЬНОГО ДЕЙСТВИЯ НА ОСНОВЕ НАЛТРЕКСОНА See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for naltrexone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 1790064-8 Sweden See Plans and Pricing 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 2017C/064 Belgium See Plans and Pricing PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456 132017000142109 Italy See Plans and Pricing PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456 SPC/GB17/078 United Kingdom See Plans and Pricing 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
2316456 LUC00054 Luxembourg See Plans and Pricing 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 See Plans and Pricing 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 2017/059 Ireland See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Baxter
AstraZeneca
Colorcon
Merck

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.