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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-five patent family members in nineteen countries.
The generic ingredient in JYNARQUE is tolvaptan. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tolvaptan profile page.
US ANDA Litigation and Generic Entry Outlook for Jynarque
There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for JYNARQUE
| International Patents: | 75 |
| 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 |
Recent Litigation for JYNARQUE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. v. Alkem Laboratories Ltd. | 2018-06-29 |
| Otsuka Pharmaceutical Co. Ltd. v. Par Pharmaceutical Inc. | 2014-06-20 |
| Otsuka Pharmaceutical Co. Ltd. v. Hetero USA Inc. | 2014-04-04 |
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 | ||||
| >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 | 204441-001 | Apr 23, 2018 | Start Trial | Start Trial |
| 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 | 204441-004 | 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 |
|---|---|---|
| Israel | 217444 | Start Trial |
| China | 1048484 | Start Trial |
| South Korea | 101077329 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for JYNARQUE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 |
