Terlivaz is a drug owned by Mallinckrodt Pharmaceuticals Ireland Ltd. It is protected by 1 US drug patent filed in 2023 out of which none have expired yet. Terlivaz's patents will be open to challenges from 14 September, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 05, 2037. Details of Terlivaz's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10335452 | Method of treating patients with hepatorenal syndrome type 1 |
Apr, 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 Terlivaz's patents.
Latest Legal Activities on Terlivaz's Patents
Given below is the list of recent legal activities going on the following patents of Terlivaz.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jan, 2023 | US10335452 |
| Patent Issue Date Used in PTA Calculation Critical | 02 Jul, 2019 | US10335452 |
| Recordation of Patent Grant Mailed Critical | 02 Jul, 2019 | US10335452 |
| Email Notification Critical | 13 Jun, 2019 | US10335452 |
| Issue Notification Mailed Critical | 12 Jun, 2019 | US10335452 |
| Dispatch to FDC | 05 Jun, 2019 | US10335452 |
| Application Is Considered Ready for Issue Critical | 22 May, 2019 | US10335452 |
| Issue Fee Payment Verified Critical | 21 May, 2019 | US10335452 |
| Issue Fee Payment Received Critical | 21 May, 2019 | US10335452 |
| Electronic Review Critical | 25 Feb, 2019 | US10335452 |
FDA has granted several exclusivities to Terlivaz. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Terlivaz, 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 Terlivaz.
Exclusivity Information
Terlivaz holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Terlivaz's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 14, 2027 |
| Orphan Drug Exclusivity(ODE-406) | Sep 14, 2029 |
US patents provide insights into the exclusivity only within the United States, but Terlivaz 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 Terlivaz's family patents as well as insights into ongoing legal events on those patents.
Terlivaz's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Terlivaz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 05, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Terlivaz Generics:
There are no approved generic versions for Terlivaz as of now.
About Terlivaz
Terlivaz is a drug owned by Mallinckrodt Pharmaceuticals Ireland Ltd. It is used for improving kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Terlivaz uses Terlipressin Acetate as an active ingredient. Terlivaz was launched by Mallinckrodt Ireland in 2022.
Approval Date:
Terlivaz was approved by FDA for market use on 14 September, 2022.
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 Terlivaz is 14 September, 2022, its NCE-1 date is estimated to be 14 September, 2026.
Active Ingredient:
Terlivaz uses Terlipressin Acetate as the active ingredient. Check out other Drugs and Companies using Terlipressin Acetate ingredient
Treatment:
Terlivaz is used for improving kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
Dosage:
Terlivaz is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.85MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |