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.
Summary for JYNARQUE
International Patents: | 86 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for JYNARQUE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JYNARQUE |
What excipients (inactive ingredients) are in JYNARQUE? | JYNARQUE excipients list |
DailyMed Link: | JYNARQUE at DailyMed |


Pharmacology for JYNARQUE
Drug Class | Vasopressin V2 Receptor Antagonist |
Mechanism of Action | Vasopressin V2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for JYNARQUE
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
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 |