JYNARQUE Drug Patent Profile
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Which patents cover Jynarque, and what generic alternatives are available?
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. Six 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: | 102 |
Patent Applications: | 1,174 |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Process for preparing benzazepine compounds or salts thereof
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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: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-003 | Apr 23, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-002 | Apr 23, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-004 | Apr 23, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-003 | Apr 23, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 | 204441-002 | Apr 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-001 | Apr 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-004 | Apr 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-003 | Apr 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-002 | Apr 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>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: 96895
Estimated Expiration: ⤷ Sign Up
Patent: 44744
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China
Patent: 1273017
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Patent: 1967107
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Patent: 2219741
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Patent: 2746229
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Cyprus
Patent: 11788
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Patent: 12496
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Patent: 16082
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Denmark
Patent: 19874
Estimated Expiration: ⤷ Sign Up
Patent: 51319
Estimated Expiration: ⤷ Sign Up
Patent: 61215
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 19874
Estimated Expiration: ⤷ Sign Up
Patent: 51319
Estimated Expiration: ⤷ Sign Up
Patent: 61215
Estimated Expiration: ⤷ Sign Up
Germany
Patent: 2006019882
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Hong Kong
Patent: 24318
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Patent: 44932
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Patent: 45835
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Patent: 48999
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Patent: 72329
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Israel
Patent: 9481
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Patent: 7444
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Patent: 7445
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Patent: 7446
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Patent: 2396
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Japan
Patent: 46587
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Patent: 83172
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Patent: 84164
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Patent: 93083
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Patent: 07091738
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Patent: 12176979
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Patent: 12197295
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Patent: 12197296
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Patent: 14139203
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Patent: 14205699
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Poland
Patent: 19874
Estimated Expiration: ⤷ Sign Up
Patent: 51319
Estimated Expiration: ⤷ Sign Up
Patent: 61215
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Portugal
Patent: 19874
Estimated Expiration: ⤷ Sign Up
Patent: 51319
Estimated Expiration: ⤷ Sign Up
Patent: 61215
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 19874
Estimated Expiration: ⤷ Sign Up
Patent: 51319
Estimated Expiration: ⤷ Sign Up
Patent: 61215
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South Korea
Patent: 1019363
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Patent: 1077329
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Patent: 1119732
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Patent: 080039459
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Patent: 100132087
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Patent: 100133028
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Patent: 110029184
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Spain
Patent: 58217
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Patent: 79153
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Patent: 27794
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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 |
---|---|---|---|
Denmark | 2261215 | ⤷ Sign Up | |
European Patent Office | 1919874 | PROCEDE DE PREPARATION DE COMPOSES DE BENZAZEPINE OU DE SELS DESDITS COMPOSES (PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF) | ⤷ Sign Up |
Spain | 2354030 | ⤷ Sign Up | |
Cyprus | 1116082 | ⤷ Sign Up | |
South Korea | 101119732 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JYNARQUE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0450097 | 09C0049 | France | ⤷ Sign Up | PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803 |
0450097 | CA 2009 00031 | Denmark | ⤷ Sign Up | |
0450097 | 300408 | Netherlands | ⤷ Sign Up | 300408, 20101018, EXPIRES: 20151017 |
0450097 | C300408 | Netherlands | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |