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Last Updated: November 3, 2024

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CUVRIOR Drug Patent Profile


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When do Cuvrior patents expire, and when can generic versions of Cuvrior launch?

Cuvrior is a drug marketed by Orphalan and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in sixteen countries.

The generic ingredient in CUVRIOR is trientine tetrahydrochloride. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trientine tetrahydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Cuvrior

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 3, 2039. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for CUVRIOR
International Patents:18
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 57
Patent Applications: 19
Drug Prices: Drug price information for CUVRIOR
What excipients (inactive ingredients) are in CUVRIOR?CUVRIOR excipients list
DailyMed Link:CUVRIOR at DailyMed
Drug patent expirations by year for CUVRIOR
Drug Prices for CUVRIOR

See drug prices for CUVRIOR

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CUVRIOR
Generic Entry Date for CUVRIOR*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Pharmacology for CUVRIOR
Paragraph IV (Patent) Challenges for CUVRIOR
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 CUVRIOR

CUVRIOR is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CUVRIOR is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CUVRIOR

Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR THE TREATMENT OF ADULT PATIENTS WITH STABLE WILSON’S DISEASE WHO ARE DE-COPPERED AND TOLERANT TO PENICILLAMINE

FDA Regulatory Exclusivity protecting CUVRIOR

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH STABLE WILSON’S DISEASE WHO ARE DE-COPPERED AND TOLERANT TO PENICILLAMINE
Exclusivity Expiration: ⤷  Sign Up

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 Y ⤷  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 CUVRIOR

When does loss-of-exclusivity occur for CUVRIOR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5080
Patent: FORMA CRISTALINA DE TETRACLORURO DE TRIETILENTETRAMINA Y USOS FARMACÉUTICOS DE LA MISMA
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 19263969
Patent: Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2020018451
Patent: 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
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 96423
Patent: FORME CRISTALLINE DU TETRACHLORHYDRATE DE TRIETHYLENETETRAMINE ET UTILISATION PHARMACEUTIQUE CORRESPONDANTE (CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1479798
Patent: 三亚乙基四胺四盐酸盐的晶形及其医药用途 (Crystalline form of triethylenetetramine tetrahydrochloride and pharmaceutical use thereof)
Estimated Expiration: ⤷  Sign Up

Patent: 4394904
Patent: 三亚乙基四胺四盐酸盐的晶形及其医药用途 (Crystalline forms of triethylenetetramine tetrahydrochloride and medical uses thereof)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 20013806
Patent: Forma cristalina de tetracloruro de trietilentetramina y usos farmacéuticos de la misma
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 2092241
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА ТЕТРАГИДРОХЛОРИДА ТРИЭТИЛЕНТЕТРАМИНА И ЕЕ ФАРМАЦЕВТИЧЕСКОЕ ПРИМЕНЕНИЕ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 52145
Patent: FORME CRISTALLINE DU TÉTRACHLORHYDRATE DE TRIÉTHYLÈNETÉTRAMINE ET UTILISATION PHARMACEUTIQUE CORRESPONDANTE (CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE)
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 724752
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 21531322
Patent: トリエチレンテトラミン四塩酸塩の結晶形およびその医薬用途
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 919
Patent: Forme cristalline du tetrachlorhydrate de triethylenetetramine et utilisation pharmaceutique correspondante
Estimated Expiration: ⤷  Sign Up

Patent: 726
Patent: Forme cristalline du tétrachlorhydrate de triéthylènetétramine et utilisation pharmaceutique correspondante
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 202010785U
Patent: CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 210005270
Patent: 트리에틸렌테트라민 테트라클로라이드의 결정형 및 이의 약제학적 용도
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 69049
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 2002956
Patent: Crystalline form of triethylenetetramine tetrachloride and its pharmaceutical uses
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CUVRIOR around the world.

Country Patent Number Title Estimated Expiration
Singapore 11202010785U CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE ⤷  Sign Up
Morocco 51919 Forme cristalline du tetrachlorhydrate de triethylenetetramine et utilisation pharmaceutique correspondante ⤷  Sign Up
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 ⤷  Sign Up
China 111479798 三亚乙基四胺四盐酸盐的晶形及其医药用途 (Crystalline form of triethylenetetramine tetrahydrochloride and pharmaceutical use thereof) ⤷  Sign Up
Germany 19724752 ⤷  Sign Up
South Korea 20210005270 트리에틸렌테트라민 테트라클로라이드의 결정형 및 이의 약제학적 용도 ⤷  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.