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Last Updated: May 4, 2024

TRIENTINE TETRAHYDROCHLORIDE - Generic Drug Details


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

Trientine tetrahydrochloride is the generic ingredient in one branded drug marketed by Orphalan and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trientine tetrahydrochloride has eighteen patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for TRIENTINE TETRAHYDROCHLORIDE
International Patents:18
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 57
Clinical Trials: 12
Patent Applications: 47
What excipients (inactive ingredients) are in TRIENTINE TETRAHYDROCHLORIDE?TRIENTINE TETRAHYDROCHLORIDE excipients list
DailyMed Link:TRIENTINE TETRAHYDROCHLORIDE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRIENTINE TETRAHYDROCHLORIDE
Generic Entry Date for TRIENTINE TETRAHYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TRIENTINE TETRAHYDROCHLORIDE

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

SponsorPhase
Alexion PharmaceuticalsPhase 2
University of ManchesterPhase 2
National Institute for Health Research, United KingdomPhase 2

See all TRIENTINE TETRAHYDROCHLORIDE clinical trials

Pharmacology for TRIENTINE TETRAHYDROCHLORIDE
Paragraph IV (Patent) Challenges for TRIENTINE TETRAHYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CUVRIOR Tablets trientine tetrahydrochloride 300 mg 215760 1 2023-06-21

US Patents and Regulatory Information for TRIENTINE TETRAHYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orphalan CUVRIOR trientine tetrahydrochloride TABLET;ORAL 215760-001 Apr 28, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Orphalan CUVRIOR trientine tetrahydrochloride TABLET;ORAL 215760-001 Apr 28, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Orphalan CUVRIOR trientine tetrahydrochloride TABLET;ORAL 215760-001 Apr 28, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Orphalan CUVRIOR trientine tetrahydrochloride TABLET;ORAL 215760-001 Apr 28, 2022 RX Yes Yes ⤷  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

International Patents for TRIENTINE TETRAHYDROCHLORIDE

Country Patent Number Title Estimated Expiration
European Patent Office 3652145 FORME CRISTALLINE DU TÉTRACHLORHYDRATE DE TRIÉTHYLÈNETÉTRAMINE ET UTILISATION PHARMACEUTIQUE CORRESPONDANTE (CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE) ⤷  Try a Trial
Brazil 112020018451 forma cristalina de tetracloreto de trietilenotetra-amina, composição farmacêutica, método de produção de formas cristalinas de tetracloreto de trietilenotetra-amina e forma cristalina ou composição farmacêutica ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2019211464 ⤷  Try a Trial
Argentina 115080 FORMA CRISTALINA DE TETRACLORURO DE TRIETILENTETRAMINA Y USOS FARMACÉUTICOS DE LA MISMA ⤷  Try a Trial
Singapore 11202010785U CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.