Korsuva is a drug owned by Cara Therapeutics Inc. It is protected by 12 US drug patents filed in 2021 out of which none have expired yet. Korsuva's patents will be open to challenges from 23 August, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 12, 2027. Details of Korsuva'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. | |||
| US10793596 | Synthetic peptide amides |
Nov, 2027
(2 years from now) | Active |
| US10017536 | Synthetic peptide amides and dimers thereof |
Nov, 2027
(2 years from now) | Active |
| US8536131 | Synthetic peptide amides and dimers thereof |
Nov, 2027
(2 years from now) | Active |
| US7727963 | Synthetic peptide amides |
Nov, 2027
(2 years from now) | Active |
| US7713937 | Synthetic peptide amides and dimeric forms thereof |
Nov, 2027
(2 years from now) | Active |
| US7402564 | Synthetic peptide amides |
Nov, 2027
(2 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). | |||
| US10138270 | Synthetic peptide amides |
Nov, 2027
(2 years from now) | Active |
| US9334305 | Synthetic peptide amides and dimers thereof |
Nov, 2027
(2 years from now) | Active |
| US8486894 | Synthetic peptide amides and dimeric forms thereof |
Nov, 2027
(2 years from now) | Active |
| US8217007 | Synthetic peptide amides |
Nov, 2027
(2 years from now) | Active |
| US9359399 | Synthetic peptide amides |
Nov, 2027
(2 years from now) | Active |
| US8236766 | Uses of synthetic peptide amides |
Nov, 2027
(2 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 Korsuva's patents.
Latest Legal Activities on Korsuva's Patents
Given below is the list of recent legal activities going on the following patents of Korsuva.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US7402564 |
| transaction for FDA Determination of Regulatory Review Period | 28 Nov, 2023 | US7402564 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 06 Oct, 2023 | US10793596 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 07 Aug, 2023 | US8236766 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 12 Jul, 2023 | US8217007 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 12 Jun, 2023 | US9359399 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 11 May, 2023 | US9334305 |
| Second letter to regulating agency to determine regulatory review period | 26 Jan, 2023 | US7402564 |
| Letter from FDA or Dept of Agriculture re PTE application | 28 Sep, 2022 | US7402564 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 26 May, 2022 | US10138270 |
FDA has granted several exclusivities to Korsuva. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Korsuva, 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 Korsuva.
Exclusivity Information
Korsuva holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Korsuva's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 23, 2026 |
US patents provide insights into the exclusivity only within the United States, but Korsuva 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 Korsuva's family patents as well as insights into ongoing legal events on those patents.
Korsuva's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Korsuva's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 12, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Korsuva Generics:
There are no approved generic versions for Korsuva as of now.
About Korsuva
Korsuva is a drug owned by Cara Therapeutics Inc. It is used for managing moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. Korsuva uses Difelikefalin Acetate as an active ingredient. Korsuva was launched by Cara Therap in 2021.
Approval Date:
Korsuva was approved by FDA for market use on 23 August, 2021.
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 Korsuva is 23 August, 2021, its NCE-1 date is estimated to be 23 August, 2025.
Active Ingredient:
Korsuva uses Difelikefalin Acetate as the active ingredient. Check out other Drugs and Companies using Difelikefalin Acetate ingredient
Treatment:
Korsuva is used for managing moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
Dosage:
Korsuva is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |