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Last Updated: March 18, 2024

Naltrexone - Generic Drug Details


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

Naltrexone is the generic ingredient in five branded drugs marketed by Teva Pharms Usa Inc, Alkermes, Accord Hlthcare, Barr, Chartwell, Elite Labs, Fosun Pharma, Specgx Llc, Sun Pharm, Teva Womens, and Pfizer, and is included in eleven 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. There is one tentative approval for this compound.

Drug Prices for naltrexone

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Drug Sales Revenue Trends for naltrexone

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Recent Clinical Trials for naltrexone

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

SponsorPhase
Inventage Lab., Inc.Phase 1
BioXcel Therapeutics IncPhase 1/Phase 2
Bicycle HealthPhase 4

See all naltrexone clinical trials

Generic filers with tentative approvals for NALTREXONE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial8MG/90MGTABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-002 Aug 19, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-005 Aug 19, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 076264-003 Mar 22, 2002 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ⤷  Try a Trial ⤷  Try a Trial
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for naltrexone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 17C1058 France ⤷  Try a Trial 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 1790064-8 Sweden ⤷  Try a Trial 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 2017/059 Ireland ⤷  Try a Trial 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

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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.