Tryvio is a drug owned by Idorsia Pharmaceuticals Ltd. It is protected by 5 US drug patents filed in 2024 out of which none have expired yet. Tryvio's patents will be open to challenges from 22 March, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 26, 2038. Details of Tryvio'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. | |||
| US10919881 | Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan |
Feb, 2038
(13 years from now) | Active |
| US8324232 | 4-pyrimidinesulfamide derivative |
Sep, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11680058 | Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan |
Jul, 2038
(13 years from now) | Active |
| US11787782 | Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases |
Mar, 2038
(13 years from now) | Active |
| US11174247 | Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases |
Nov, 2037
(12 years from now) | Active |
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 Tryvio's patents.
Latest Legal Activities on Tryvio's Patents
Given below is the list of recent legal activities going on the following patents of Tryvio.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Initial letter Re: PTE Application to regulating agency | 16 May, 2024 | US8324232 |
| Patent Term Extension Application under 35 USC 156 Filed | 10 May, 2024 | US8324232 |
| Mail Patent eGrant Notification | 17 Oct, 2023 | US11787782 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Oct, 2023 | US11787782 |
| Recordation of Patent eGrant | 17 Oct, 2023 | US11787782 |
| Recordation of Patent Grant Mailed Critical | 17 Oct, 2023 | US11787782 |
| Email Notification Critical | 17 Oct, 2023 | US11787782 |
| Patent eGrant Notification | 17 Oct, 2023 | US11787782 |
| Email Notification Critical | 28 Sep, 2023 | US11787782 |
| Issue Notification Mailed Critical | 27 Sep, 2023 | US11787782 |
FDA has granted several exclusivities to Tryvio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tryvio, 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 Tryvio.
Exclusivity Information
Tryvio holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Tryvio's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 22, 2029 |
US patents provide insights into the exclusivity only within the United States, but Tryvio 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 Tryvio's family patents as well as insights into ongoing legal events on those patents.
Tryvio's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tryvio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 26, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tryvio Generics:
There are no approved generic versions for Tryvio as of now.
About Tryvio
Tryvio is a drug owned by Idorsia Pharmaceuticals Ltd. Tryvio uses Aprocitentan as an active ingredient. Tryvio was launched by Idorsia in 2024.
Approval Date:
Tryvio was approved by FDA for market use on 19 March, 2024.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Tryvio is 19 March, 2024, its NCE-1 date is estimated to be 22 March, 2028.
Active Ingredient:
Tryvio uses Aprocitentan as the active ingredient. Check out other Drugs and Companies using Aprocitentan ingredient
Dosage:
Tryvio is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12.5MG | TABLET | Prescription | ORAL |