Cuvrior is a drug owned by Orphalan Sa. It is protected by 2 US drug patents filed in 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 03, 2039. Details of Cuvrior'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. | |||
| US10988436 | Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use |
May, 2039
(13 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). | |||
| US11072577 | Crystalline form of triethylenetetramine tetrahydrochloride and its pharmaceutical use |
May, 2039
(13 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 Cuvrior's patents.
Latest Legal Activities on Cuvrior's Patents
Given below is the list of recent legal activities going on the following patents of Cuvrior.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 31 Aug, 2021 | US11072577 |
| Email Notification Critical | 26 Aug, 2021 | US11072577 |
| Mail Certificate of Correction Memo | 25 Aug, 2021 | US11072577 |
| Certificate of Correction Memo | 24 Aug, 2021 | US11072577 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Jul, 2021 | US11072577 |
| Recordation of Patent Grant Mailed Critical | 27 Jul, 2021 | US11072577 |
| Email Notification Critical | 08 Jul, 2021 | US11072577 |
| Issue Notification Mailed Critical | 07 Jul, 2021 | US11072577 |
| Email Notification Critical | 25 Jun, 2021 | US11072577 |
| Application ready for PDX access by participating foreign offices Critical | 24 Jun, 2021 | US11072577 |
FDA has granted several exclusivities to Cuvrior. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cuvrior, 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 Cuvrior.
Exclusivity Information
Cuvrior holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Cuvrior's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 28, 2025 |
| Orphan Drug Exclusivity(ODE-401) | Apr 28, 2029 |
US patents provide insights into the exclusivity only within the United States, but Cuvrior 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 Cuvrior's family patents as well as insights into ongoing legal events on those patents.
Cuvrior's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cuvrior's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 03, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cuvrior Generics:
There are no approved generic versions for Cuvrior as of now.
How can I launch a generic of Cuvrior before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cuvrior's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cuvrior'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 Cuvrior -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 300 mg | 21 Jun, 2023 | 1 | 03 May, 2039 |
About Cuvrior
Cuvrior is a drug owned by Orphalan Sa. It is used for the treatment of stable Wilson's disease in adult patients who are already de-coppered and tolerant to penicillamine. Cuvrior uses Trientine Tetrahydrochloride as an active ingredient. Cuvrior was launched by Orphalan in 2022.
Approval Date:
Cuvrior was approved by FDA for market use on 28 April, 2022.
Active Ingredient:
Cuvrior uses Trientine Tetrahydrochloride as the active ingredient. Check out other Drugs and Companies using Trientine Tetrahydrochloride ingredient
Treatment:
Cuvrior is used for the treatment of stable Wilson's disease in adult patients who are already de-coppered and tolerant to penicillamine.
Dosage:
Cuvrior is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG | TABLET | Prescription | ORAL |