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Last Updated: July 10, 2020

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NALTREXONE HYDROCHLORIDE Drug Profile


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When do Naltrexone Hydrochloride patents expire, and when can generic versions of Naltrexone Hydrochloride launch?

Naltrexone Hydrochloride is a drug marketed by Accord Hlthcare, Apotex, Barr, Elite Labs, Fosun Pharma, Specgx Llc, and Sun Pharm. and is included in seven NDAs.

The generic ingredient in NALTREXONE HYDROCHLORIDE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Naltrexone Hydrochloride

A generic version of NALTREXONE HYDROCHLORIDE was approved as naltrexone hydrochloride by BARR on May 8th, 1998.

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Drug patent expirations by year for NALTREXONE HYDROCHLORIDE
Recent Clinical Trials for NALTREXONE HYDROCHLORIDE

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SponsorPhase
Oslo University HospitalPhase 4
The Emmes Company, LLCPhase 2/Phase 3
Hennepin Healthcare Research InstitutePhase 2/Phase 3

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Pharmacology for NALTREXONE HYDROCHLORIDE
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

US Patents and Regulatory Information for NALTREXONE HYDROCHLORIDE

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   Start Trial   Start Trial   Start Trial
Specgx Llc NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 076264-002 Mar 22, 2002 AB RX No Yes   Start Trial   Start Trial   Start Trial
Elite Labs NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 075274-001 May 26, 1999 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Colorcon
McKesson
Express Scripts
McKinsey

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