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JYNARQUE Drug Profile
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» See Plans and PricingWhen 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-seven patent family members in nineteen countries.
The generic ingredient in JYNARQUE is tolvaptan. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
US ANDA 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: | 77 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| 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 |
| DailyMed Link: | JYNARQUE at DailyMed |
Pharmacology for JYNARQUE
| Drug Class | Vasopressin V2 Receptor Antagonist |
| Mechanism of Action | Vasopressin V2 Receptor Antagonists |
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 | ||||
| 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 | 204441-003 | Apr 23, 2018 | RX | Yes | Yes | 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 | 204441-003 | Apr 23, 2018 | Start Trial | Start Trial |
| 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 | 204441-002 | Apr 23, 2018 | Start Trial | Start Trial |
| Otsuka Pharm Co Ltd | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-005 | Apr 23, 2018 | Start Trial | Start Trial |
| Otsuka Pharm Co Ltd | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-002 | Apr 23, 2018 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for JYNARQUE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2014139203 | Start Trial |
| Hong Kong | 1148999 | Start Trial |
| South Korea | 20100132087 | Start Trial |
| China | 1027505 | Start Trial |
| China | 1107146 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for JYNARQUE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0450097 | 09C0049 | France | Start Trial | PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803 |
| 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 | SPC/GB09/037 | United Kingdom | Start 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 | 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 |
