Jynarque is a drug owned by Otsuka Pharmaceutical Co Ltd. It is protected by 4 US drug patents filed from 2018 to 2021. Out of these, 2 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 07, 2030. Details of Jynarque's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8501730 | Process for preparing benzazepine compounds or salts thereof |
Sep, 2026
(1 year, 3 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10905694 | Pharmaceutical solid preparation comprising benzazepines and production method thereof |
Apr, 2030
(4 years from now) | Active |
| US5753677 | Benzoheterocyclic compounds |
May, 2020
(4 years ago) |
Expired
|
| US5972882 | Treatment of polycystic kidney disease using vasopressin V2 receptor antagonists |
Dec, 2018
(6 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Jynarque's patents.
Latest Legal Activities on Jynarque's Patents
Given below is the list of recent legal activities going on the following patents of Jynarque.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Jul, 2024 | US10905694 |
| Recordation of Patent Grant Mailed Critical | 02 Feb, 2021 | US10905694 |
| Patent Issue Date Used in PTA Calculation Critical | 02 Feb, 2021 | US10905694 |
| Email Notification Critical | 14 Jan, 2021 | US10905694 |
| Issue Notification Mailed Critical | 13 Jan, 2021 | US10905694 |
| Application Is Considered Ready for Issue Critical | 28 Dec, 2020 | US10905694 |
| Dispatch to FDC | 28 Dec, 2020 | US10905694 |
| Issue Fee Payment Received Critical | 23 Dec, 2020 | US10905694 |
| Issue Fee Payment Verified Critical | 23 Dec, 2020 | US10905694 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Sep, 2020 | US8501730 (Litigated) |
FDA has granted several exclusivities to Jynarque. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jynarque, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Jynarque.
Exclusivity Information
Jynarque holds 2 exclusivities. All of its exclusivities have expired in 2025. Details of Jynarque's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-779) | Apr 23, 2021 |
| Orphan Drug Exclusivity(ODE-178) | Apr 23, 2025 |
US patents provide insights into the exclusivity only within the United States, but Jynarque is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Jynarque's family patents as well as insights into ongoing legal events on those patents.
Jynarque's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Jynarque's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 07, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jynarque Generic API suppliers:
Tolvaptan is the generic name for the brand Jynarque. 5 different companies have already filed for the generic of Jynarque, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Jynarque's generic
How can I launch a generic of Jynarque before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Jynarque's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Jynarque's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Jynarque -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg, 30 mg, 45 mg, 60 mg, 90 mg | 08 Apr, 2021 | 1 | 07 Apr, 2030 |
Alternative Brands for Jynarque
Jynarque which is used for treating autosomal dominant polycystic kidney disease., has several other brand drugs using the same active ingredient (Tolvaptan). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Otsuka |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tolvaptan, Jynarque's active ingredient. Check the complete list of approved generic manufacturers for Jynarque
About Jynarque
Jynarque is a drug owned by Otsuka Pharmaceutical Co Ltd. It is used for treating autosomal dominant polycystic kidney disease. Jynarque uses Tolvaptan as an active ingredient. Jynarque was launched by Otsuka in 2018.
Approval Date:
Jynarque was approved by FDA for market use on 23 April, 2018.
Active Ingredient:
Jynarque uses Tolvaptan as the active ingredient. Check out other Drugs and Companies using Tolvaptan ingredient
Treatment:
Jynarque is used for treating autosomal dominant polycystic kidney disease.
Dosage:
Jynarque is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG | TABLET | Prescription | ORAL |
| 15MG | TABLET | Prescription | ORAL |
| 90MG | TABLET | Prescription | ORAL |
| 30MG | TABLET | Prescription | ORAL |
| 45MG | TABLET | Prescription | ORAL |