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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CUVRIOR
*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
| Drug Class | Copper Chelator |
| Mechanism of Action | Copper Chelating Activity Metal Chelating Activity |
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 |
|---|---|---|---|
| Spain | 2769049 | ⤷ Sign Up | |
| Taiwan | 202002956 | Crystalline form of triethylenetetramine tetrachloride and its pharmaceutical uses | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2019211464 | ⤷ Sign Up | |
| Canada | 3096423 | FORME CRISTALLINE DU TETRACHLORHYDRATE DE TRIETHYLENETETRAMINE ET UTILISATION PHARMACEUTIQUE CORRESPONDANTE (CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE) | ⤷ Sign Up |
| Singapore | 11202010785U | CRYSTALLINE FORM OF TRIETHYLENETETRAMINE TETRAHYDROCHLORIDE AND ITS PHARMACEUTICAL USE | ⤷ 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.
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