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Last Updated: May 19, 2022

JYNARQUE Drug Patent 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 and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-six patent family members in twenty-four countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Jynarque

A generic version of JYNARQUE was approved as tolvaptan by ALKEM LABS LTD on May 19th, 2020.

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Paragraph IV (Patent) Challenges for JYNARQUE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JYNARQUE Tablets tolvaptan 15 mg, 30 mg, 45 mg, 60 mg, 90 mg 204441 1 2021-04-08

US Patents and Regulatory Information for JYNARQUE

JYNARQUE is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting JYNARQUE

Pharmaceutical solid preparation comprising benzazepines and production method thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process for preparing benzazepine compounds or salts thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting JYNARQUE

INDICATED TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-001 Apr 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-003 Apr 23, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-002 Apr 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-004 Apr 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-003 Apr 23, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-005 Apr 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-001 Apr 23, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 JYNARQUE tolvaptan TABLET;ORAL 204441-004 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-003 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-005 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-005 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-002 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-001 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-003 Apr 23, 2018 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for JYNARQUE

When does loss-of-exclusivity occur for JYNARQUE?

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

Austria

Patent: 6895
Estimated Expiration: See Plans and Pricing

Patent: 4744
Estimated Expiration: See Plans and Pricing

China

Patent: 1273017
Estimated Expiration: See Plans and Pricing

Patent: 1967107
Estimated Expiration: See Plans and Pricing

Patent: 2219741
Estimated Expiration: See Plans and Pricing

Patent: 2746229
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11788
Estimated Expiration: See Plans and Pricing

Patent: 12496
Estimated Expiration: See Plans and Pricing

Patent: 16082
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 19874
Estimated Expiration: See Plans and Pricing

Patent: 51319
Estimated Expiration: See Plans and Pricing

Patent: 61215
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 19874
Estimated Expiration: See Plans and Pricing

Patent: 51319
Estimated Expiration: See Plans and Pricing

Patent: 61215
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2006019882
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 24318
Estimated Expiration: See Plans and Pricing

Patent: 44932
Estimated Expiration: See Plans and Pricing

Patent: 45835
Estimated Expiration: See Plans and Pricing

Patent: 48999
Estimated Expiration: See Plans and Pricing

Patent: 72329
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9481
Estimated Expiration: See Plans and Pricing

Patent: 7444
Estimated Expiration: See Plans and Pricing

Patent: 7445
Estimated Expiration: See Plans and Pricing

Patent: 7446
Estimated Expiration: See Plans and Pricing

Patent: 2396
Estimated Expiration: See Plans and Pricing

Japan

Patent: 46587
Estimated Expiration: See Plans and Pricing

Patent: 83172
Estimated Expiration: See Plans and Pricing

Patent: 84164
Estimated Expiration: See Plans and Pricing

Patent: 93083
Estimated Expiration: See Plans and Pricing

Patent: 07091738
Estimated Expiration: See Plans and Pricing

Patent: 12176979
Estimated Expiration: See Plans and Pricing

Patent: 12197295
Estimated Expiration: See Plans and Pricing

Patent: 12197296
Estimated Expiration: See Plans and Pricing

Patent: 14139203
Estimated Expiration: See Plans and Pricing

Patent: 14205699
Estimated Expiration: See Plans and Pricing

Poland

Patent: 19874
Estimated Expiration: See Plans and Pricing

Patent: 51319
Estimated Expiration: See Plans and Pricing

Patent: 61215
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 19874
Estimated Expiration: See Plans and Pricing

Patent: 51319
Estimated Expiration: See Plans and Pricing

Patent: 61215
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 19874
Estimated Expiration: See Plans and Pricing

Patent: 51319
Estimated Expiration: See Plans and Pricing

Patent: 61215
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1019363
Estimated Expiration: See Plans and Pricing

Patent: 1077329
Estimated Expiration: See Plans and Pricing

Patent: 1119732
Estimated Expiration: See Plans and Pricing

Patent: 080039459
Estimated Expiration: See Plans and Pricing

Patent: 100132087
Estimated Expiration: See Plans and Pricing

Patent: 100133028
Estimated Expiration: See Plans and Pricing

Patent: 110029184
Estimated Expiration: See Plans and Pricing

Spain

Patent: 58217
Estimated Expiration: See Plans and Pricing

Patent: 79153
Estimated Expiration: See Plans and Pricing

Patent: 27794
Estimated Expiration: See Plans and Pricing

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 JYNARQUE around the world.

Country Patent Number Title Estimated Expiration
Japan H04154765 BENZOHETEROCYCLIC COMPOUND See Plans and Pricing
South Korea 101019363 See Plans and Pricing
Croatia P20100676 See Plans and Pricing
Austria 496895 See Plans and Pricing
Israel 189481 תהליך עבור הפקת תרכובות 2,3,4,5-טטרההידרו-h1-1-בנזאזפין או מלחים מזה ותרכובת נקייה מאוד המופקת על ידי תהליך האמור (Process for producing 2,3,4,5-tetrahydro-1h-1- benzazepine compounds or salts thereof and highly pure compounds produced by said process) See Plans and Pricing
Germany 122009000062 See Plans and Pricing
South Korea 101077329 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JYNARQUE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0450097 300408 Netherlands See Plans and Pricing 300408, 20101018, EXPIRES: 20151017
0450097 C300408 Netherlands See Plans and Pricing PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
0450097 SPC/GB09/037 United Kingdom See Plans and Pricing PRODUCT NAME: TOLVAPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/09/539/001 20090803; UK EU/1/09/539/002 20090803; UK EU/1/09/539/003 20090803; UK EU/1/09/539/004 20090803
0450097 09C0049 France See Plans and Pricing PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
0450097 CA 2009 00031 Denmark See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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