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Last Updated: July 14, 2020

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Trientine hydrochloride - Generic Drug Details

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

Trientine hydrochloride is the generic ingredient in three branded drugs marketed by Kadmon Pharms Llc, Bausch, Amneal Pharms Llc, Dr Reddys Labs Ltd, Lupin Ltd, MSN, Navinta Llc, Par Pharm Inc, Rising, Watson Labs Teva, and Zydus Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for trientine hydrochloride. Thirteen suppliers are listed for this compound.

Recent Clinical Trials for trientine hydrochloride

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

SponsorPhase
Alexion PharmaceuticalsPhase 2
GMP-Orphan SASPhase 3
University of British ColumbiaPhase 2

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Pharmacology for trientine hydrochloride
Drug ClassMetal Chelator
Mechanism of ActionMetal Chelating Activity
Medical Subject Heading (MeSH) Categories for trientine hydrochloride

US Patents and Regulatory Information for trientine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms TRIENTINE HYDROCHLORIDE trientine hydrochloride CAPSULE;ORAL 211554-001 Apr 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd TRIENTINE HYDROCHLORIDE trientine hydrochloride CAPSULE;ORAL 211076-001 Jul 3, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Navinta Llc TRIENTINE HYDROCHLORIDE trientine hydrochloride CAPSULE;ORAL 211251-001 Jan 16, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc TRIENTINE HYDROCHLORIDE trientine hydrochloride CAPSULE;ORAL 210096-001 Sep 25, 2019 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:

Mallinckrodt
Dow
Colorcon
AstraZeneca
Johnson and Johnson
Moodys

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