Korsuva Generic: When Will Generic Difelikefalin Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Korsuva Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July to December 2032 A 6-month window Why then?
- Has the FDA approved a generic? August 2026 1 company approved Why not on sale?
- When does the last patent end? November 2032 12 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic difelikefalin acetate is expected to be available between July and December 2032. None is for sale yet.
Why July to December 2032?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. One company has held an approval since August 2026, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. See the price pattern
What should I do now?
Keep taking Korsuva as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Korsuva by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
- Price competition
- Strong 5 companies have filed, 5 first in line
- Brand sales
- $11M a yearSmaller seller
- FDA approved 2021 August 2021 FDA Orange Book
- Patents listed 12 last runs to November 2032 FDA Orange Book
- Generics FDA-approved 1 company, approved August 2026 FDA Orange Book
- Medicaid prescriptions 60 in the last four reported quarters, $37.20 CMS Medicaid drug utilization, to Q1 2026
Korsuva’s Road to a Generic
Korsuva has had the market to itself since the FDA approved it in August 2021 (Vifor (International) Inc). Its FDA protections on record ended by August 2026. Its 12 listed patents run to November 2032. Generic companies have challenged its patents with the FDA since August 2025.
The first generic of Korsuva is expected between July and December 2032.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Korsuva Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Korsuva’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,713,937 | The active ingredient; the product’s formulation; a way of using it (U-3204) | November 2027 | Active |
| 7,727,963 | The active ingredient; the product’s formulation; a way of using it (U-3204) | November 2027 | Active |
| 8,217,007 | A way of using it (U-3204) | November 2027 | Active |
| 8,236,766 | A way of using it (U-3204) | November 2027 | Active |
| 8,486,894 | A way of using it (U-3204) | November 2027 | Active |
| 8,536,131 | The active ingredient; the product’s formulation; a way of using it (U-3204) | November 2027 | Active |
| 9,334,305 | A way of using it (U-3204) | November 2027 | Active |
| 9,359,399 | A way of using it (U-3204) | November 2027 | Active |
| 10,017,536 | The active ingredient; a way of using it (U-3204) | November 2027 | Active |
| 10,138,270 | A way of using it (U-3204) | November 2027 | Active |
| 10,793,596 | The active ingredient; the product’s formulation; a way of using it (U-3204) | November 2027 | Active |
| 7,402,564 | The active ingredient; the product’s formulation; a way of using it (U-3204) | November 2032 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | August 2026 | Ended |
Source: FDA Orange Book, application 214916. Patent numbers open the patent on Google Patents.
Patent Challenges to Korsuva
The first patent challenge to Korsuva reached the FDA in August 2025, from 5 companies on that first day. The FDA approved a first challenger’s generic in August 2026, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Korsuva’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Intravenous solution, 0.065 mg/1.3 mL | August 2025 | 5 companies | First challenger eligible decided September 2026 | August 2026 | Not yet | November 2027 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Difelikefalin Acetate
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
5 companies have applied to the FDA to make generic difelikefalin acetate.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 5 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Korsuva’s patents with the FDA since August 2025: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in August 2026. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic difelikefalin acetate for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Qilu Pharmaceutical Hainan Co Ltd | August 2026 | EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) | AP |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Korsuva Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Korsuva, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Korsuva
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicaid Prescriptions by Quarter
60 prescriptions in the four quarters to Q1 2026, $37.20 paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 37 | $37 |
| Q4 2025 | 0 | $0 |
| Q3 2025 | 23 | $0 |
| Q1 2025 | 0 | $0 |
Source: CMS Medicaid State Drug Utilization Data, over Korsuva’s own package codes.
Korsuva Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) | Solution | Intravenous | August 2021 | Prescription reference product |
Source: FDA Orange Book, Vifor (International) Inc. Listed for sale today by Vifor (International) Inc. and Vifor (International), Inc. (FDA NDC Directory).
Korsuva NDC Codes and Packages
Each Korsuva package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 59353-0065-12 | DIFELIKEFALIN ACETATE 50 ug/mL injection, solution | tray of 12 vials of 1.3 mL | Vifor (International), Inc. |
| 59353-0065-12 | DIFELIKEFALIN ACETATE 50 ug/mL injection, solution | tray of 12 vials of 1.3 mL | Vifor (International), Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Korsuva’s own FDA approval (NDA 214916) are listed, never a generic. Some codes belong to companies that repackage Korsuva: it is the same medicine in a different package.
What a Generic Korsuva Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Korsuva as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Korsuva”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Korsuva
Is there a generic for Korsuva right now?
No. As of October 9, 2026 no generic difelikefalin acetate is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Korsuva go generic?
July to December 2032 is the expected window, and that is likely but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Will generic difelikefalin acetate be the same as Korsuva?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Korsuva?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in August 2026: Qilu Pharmaceutical Hainan Co Ltd. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Korsuva patent expire?
The FDA Orange Book lists 12 patents for Korsuva; the last runs to November 2032. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (July to December 2032) weighs all of that.
Has anyone challenged the Korsuva patents?
Yes. The first patent challenge to Korsuva reached the FDA in August 2025, from 5 companies on that first day. The FDA approved a first challenger’s generic in August 2026, and the list records no sale by a first challenger yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected July to December 2032 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- IdvynsoDoravirine and IslatravirAugust 2032
- NatestoTestosteroneMarch 2034
- Absorica LDIsotretinoinMay 2035
- CysviewHexaminolevulinate HydrochlorideJanuary 2038
- RhapsidoRemibrutinibJanuary 2043
- VanrafiaAtrasentan HydrochlorideMarch 2043
About Korsuva
- Generic name difelikefalin acetate
- How it is taken Into a vein (IV)
- Company Vifor (International) Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since August 2025 (FDA)
- More drugs Brand-name drugs starting with K
- Have a question? A pharmacist answers, free. Ask about Korsuva
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.