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Last Updated: February 23, 2020

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JYNARQUE Drug Profile


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

Jynarque is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are two patents protecting this drug.

This drug has seventy-five patent family members in nineteen countries.

The generic ingredient in JYNARQUE is tolvaptan. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tolvaptan profile page.

US ANDA Litigation and Generic Entry Outlook for Jynarque

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for JYNARQUE
Drug Prices for JYNARQUE

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Recent Litigation for JYNARQUE

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District Court Litigation
Case NameDate
Otsuka Pharmaceutical Co., Ltd. v. Alkem Laboratories Ltd.2018-06-29
Otsuka Pharmaceutical Co. Ltd. v. Par Pharmaceutical Inc.2014-06-20
Otsuka Pharmaceutical Co. Ltd. v. Hetero USA Inc.2014-04-04

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Pharmacology for JYNARQUE

US Patents and Regulatory Information for JYNARQUE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-001 Apr 23, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-005 Apr 23, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-002 Apr 23, 2018 RX Yes 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

Expired US Patents for JYNARQUE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-001 Apr 23, 2018   Start Trial   Start Trial
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-003 Apr 23, 2018   Start Trial   Start Trial
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-004 Apr 23, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for JYNARQUE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0450097 C300408 Netherlands   Start Trial PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
0450097 300408 Netherlands   Start Trial 300408, 20101018, EXPIRES: 20151017
0450097 CA 2009 00031 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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