Prescription medicine
Difelikefalin Brand names: Korsuva
Difelikefalin (Korsuva) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the difelikefalin FDA label on DailyMed (effective August 26, 2025, Vifor (International), Inc.); the NDA 214916 record on Drugs@FDA; every difelikefalin label on DailyMed.
Highlights of the record
FDA label of August 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
Forms and strengths
Injection (solution).
On the market
- Earliest approval on file
- August 23, 2021 Korsuva, Vifor Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first August 31, 2026; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 12, 2032 Korsuva injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 399 through July 30, 2026
What is difelikefalin used for?
From the label: indications and usageKORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). KORSUVA is a kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). ( 1 ) Limitation of Use Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population. ( 1 ) Limitations of Use KORSUVA has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.
FDA pharmacologic class: Kappa Opioid Receptor Agonist.
Source: FDA drug label (Korsuva), Vifor (International), Inc., effective August 26, 2025 (SPL set 0c7b81f2-0fd3-47cb-8b0f-185e07f19c87), via openFDA; the full label on DailyMed
Is there a generic for difelikefalin (Korsuva)?
The FDA approved the first generic difelikefalin on August 31, 2026. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 12 patents for Korsuva injection: the compound patent runs to November 12, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2026 first generic approved
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for difelikefalin?
The FDA Adverse Event Reporting System holds 399 reports that list difelikefalin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 62 are coded as a death and 120 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Difelikefalin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other