Trientine tetrahydrochloride - Generic Drug Details
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What are the generic drug 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: | 13 |
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
Sponsor | Phase |
---|---|
Orphalan | Phase 1 |
Alexion Pharmaceuticals | Phase 2 |
University of Manchester | Phase 2 |
Pharmacology for trientine tetrahydrochloride
Drug Class | Copper Chelator |
Mechanism of Action | Copper Chelating Activity Metal Chelating Activity |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Orphalan | CUVRIOR | trientine tetrahydrochloride | TABLET;ORAL | 215760-001 | Apr 28, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Orphalan | CUVRIOR | trientine tetrahydrochloride | TABLET;ORAL | 215760-001 | Apr 28, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 |
---|---|---|---|
South Korea | 20210005270 | 트리에틸렌테트라민 테트라클로라이드의 결정형 및 이의 약제학적 용도 | ⤷ Sign Up |
Morocco | 51919 | Forme cristalline du tetrachlorhydrate de triethylenetetramine et utilisation pharmaceutique correspondante | ⤷ Sign Up |
Colombia | 2020013806 | Forma cristalina de tetracloruro de trietilentetramina y usos farmacéuticos de la misma | ⤷ Sign Up |
>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.