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 |
Raw Ingredient (Bulk) Api Vendors: | 101 |
Patent Applications: | 1,299 |
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Process for preparing benzazepine compounds or salts thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-003 | Apr 23, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-002 | Apr 23, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-004 | Apr 23, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-003 | Apr 23, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-005 | Apr 23, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-001 | Apr 23, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-003 | Apr 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-001 | Apr 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-002 | Apr 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-002 | Apr 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-005 | Apr 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-004 | Apr 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-005 | Apr 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for JYNARQUE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Otsuka Pharmaceutical Netherlands B.V. | Jinarc | tolvaptan | EMEA/H/C/002788 Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease. |
Authorised | no | no | no | 2015-05-27 | |
Otsuka Pharmaceutical Netherlands B.V. | Samsca | tolvaptan | EMEA/H/C/000980 Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH)., |
Authorised | no | no | no | 2009-08-02 | |
Accord Healthcare S.L.U. | Tolvaptan Accord | tolvaptan | EMEA/H/C/005961 Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH). |
Authorised | yes | no | no | ||
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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: ⤷ Try a Trial
Patent: 4744
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1273017
Estimated Expiration: ⤷ Try a Trial
Patent: 1967107
Estimated Expiration: ⤷ Try a Trial
Patent: 2219741
Estimated Expiration: ⤷ Try a Trial
Patent: 2746229
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 11788
Estimated Expiration: ⤷ Try a Trial
Patent: 12496
Estimated Expiration: ⤷ Try a Trial
Patent: 16082
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 19874
Estimated Expiration: ⤷ Try a Trial
Patent: 51319
Estimated Expiration: ⤷ Try a Trial
Patent: 61215
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 19874
Estimated Expiration: ⤷ Try a Trial
Patent: 51319
Estimated Expiration: ⤷ Try a Trial
Patent: 61215
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2006019882
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 24318
Estimated Expiration: ⤷ Try a Trial
Patent: 44932
Estimated Expiration: ⤷ Try a Trial
Patent: 45835
Estimated Expiration: ⤷ Try a Trial
Patent: 48999
Estimated Expiration: ⤷ Try a Trial
Patent: 72329
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 9481
Estimated Expiration: ⤷ Try a Trial
Patent: 7444
Estimated Expiration: ⤷ Try a Trial
Patent: 7445
Estimated Expiration: ⤷ Try a Trial
Patent: 7446
Estimated Expiration: ⤷ Try a Trial
Patent: 2396
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 46587
Estimated Expiration: ⤷ Try a Trial
Patent: 83172
Estimated Expiration: ⤷ Try a Trial
Patent: 84164
Estimated Expiration: ⤷ Try a Trial
Patent: 93083
Estimated Expiration: ⤷ Try a Trial
Patent: 07091738
Estimated Expiration: ⤷ Try a Trial
Patent: 12176979
Estimated Expiration: ⤷ Try a Trial
Patent: 12197295
Estimated Expiration: ⤷ Try a Trial
Patent: 12197296
Estimated Expiration: ⤷ Try a Trial
Patent: 14139203
Estimated Expiration: ⤷ Try a Trial
Patent: 14205699
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 19874
Estimated Expiration: ⤷ Try a Trial
Patent: 51319
Estimated Expiration: ⤷ Try a Trial
Patent: 61215
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 19874
Estimated Expiration: ⤷ Try a Trial
Patent: 51319
Estimated Expiration: ⤷ Try a Trial
Patent: 61215
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 19874
Estimated Expiration: ⤷ Try a Trial
Patent: 51319
Estimated Expiration: ⤷ Try a Trial
Patent: 61215
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1019363
Estimated Expiration: ⤷ Try a Trial
Patent: 1077329
Estimated Expiration: ⤷ Try a Trial
Patent: 1119732
Estimated Expiration: ⤷ Try a Trial
Patent: 080039459
Estimated Expiration: ⤷ Try a Trial
Patent: 100132087
Estimated Expiration: ⤷ Try a Trial
Patent: 100133028
Estimated Expiration: ⤷ Try a Trial
Patent: 110029184
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 58217
Estimated Expiration: ⤷ Try a Trial
Patent: 79153
Estimated Expiration: ⤷ Try a Trial
Patent: 27794
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
South Korea | 20100132087 | PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF | ⤷ Try a Trial |
Hong Kong | 1144932 | PROCESS FOR PREPARING DERIVATIVES OF BENZOIC ACID | ⤷ Try a Trial |
Japan | 2012197295 | PROCESS FOR PREPARING BENZOAZEPINE COMPOUND OR SALT THEREOF | ⤷ Try a Trial |
Portugal | 1919874 | ⤷ Try a Trial | |
Hong Kong | 1145835 | 製備苯並氮雜卓化合物或其鹽的方法 (PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF) | ⤷ Try a Trial |
Israel | 217444 | תהליך עבור תרכובות בנזאפין או מלחים מזה (Process for preparing benzazepine compounds or salts thereof) | ⤷ Try a Trial |
Austria | 489944 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JYNARQUE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0450097 | SPC/GB09/037 | United Kingdom | ⤷ Try a Trial | 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 | CA 2009 00031 | Denmark | ⤷ Try a Trial | |
0450097 | C300408 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803 |
0450097 | 09C0049 | France | ⤷ Try a Trial | PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803 |
0450097 | 300408 | Netherlands | ⤷ Try a Trial | 300408, 20101018, EXPIRES: 20151017 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |