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Last Updated: August 14, 2020

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NALTREXONE HYDROCHLORIDE - Generic Drug Details

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

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

There are nineteen drug master file entries for naltrexone hydrochloride. Eleven suppliers are listed for this compound.

Recent Clinical Trials for NALTREXONE HYDROCHLORIDE

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

SponsorPhase
Oslo University HospitalPhase 4
Hennepin Healthcare Research InstitutePhase 2/Phase 3
Stanford UniversityPhase 2

See all NALTREXONE HYDROCHLORIDE clinical trials

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
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-006 Aug 19, 2016 DISCN No No   Start Trial   Start Trial Y   Start Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-003 Aug 19, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Fosun Pharma NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 075434-001 Mar 8, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-006 Aug 19, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 207905-001 Jul 21, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-004 Aug 19, 2016 DISCN 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:

Merck
Colorcon
Moodys
Baxter
McKesson
Mallinckrodt

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