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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Covington
US Department of Justice
Teva
Dow
UBS
Baxter
US Army
Healthtrust

Generated: October 21, 2018

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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 naltrexone hydrochloride freedom to operate?

Naltrexone hydrochloride is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Apotex Inc, Barr, Elite Labs, Fosun Pharma, Specgx Llc, Sun Pharma Global, 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. Fifteen suppliers are listed for this compound.

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
Barr NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 074918-001 May 8, 1998 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 207905-001 Jul 21, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-005 Aug 19, 2016 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-003 Aug 19, 2016 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Specgx Llc NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 076264-001 Mar 22, 2002 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer Inc 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 Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-006 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

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Covington
US Department of Justice
Teva
Dow
UBS
Baxter
US Army
Healthtrust

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