FDA Orange Book
Generic for Korsuva
Korsuva contains difelikefalin acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Korsuva is difelikefalin acetate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
Run it in Rivvi
Map Korsuva and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Korsuva products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) | Marketed (Rx) | AP | 1 | AP |
NDA 214916, held by VIFOR (INTERNATIONAL) INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic difelikefalin acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| QILU PHARMACEUTICAL HAINAN CO LTD | 220919 | AP (A-rated, therapeutically equivalent) | August 31, 2026 | EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) |
Korsuva patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10793596 | November 12, 2027 | Drug substance, Drug product | U-3204 | 214916 |
| 10138270 | November 12, 2027 | Method of use | U-3204 | 214916 |
| 10017536 | November 12, 2027 | Drug substance | U-3204 | 214916 |
| 9359399 | November 12, 2027 | Method of use | U-3204 | 214916 |
| 9334305 | November 12, 2027 | Method of use | U-3204 | 214916 |
| 8536131 | November 12, 2027 | Drug substance, Drug product | U-3204 | 214916 |
| 8486894 | November 12, 2027 | Method of use | U-3204 | 214916 |
| 8236766 | November 12, 2027 | Method of use | U-3204 | 214916 |
| 8217007 | November 12, 2027 | Method of use | U-3204 | 214916 |
| 7727963 | November 12, 2027 | Drug substance, Drug product | U-3204 | 214916 |
| 7713937 | November 12, 2027 | Drug substance, Drug product | U-3204 | 214916 |
| 7402564 | November 12, 2032 | Drug substance, Drug product | U-3204 | 214916 |
Korsuva exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 23, 2026 | 214916 |
Korsuva NDC codes
Questions
Is there a generic for Korsuva?
Yes. The generic name for Korsuva is difelikefalin acetate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Korsuva?
The active ingredient in Korsuva is difelikefalin acetate, per the FDA Orange Book.
When does the Korsuva patent expire?
The last patent listed for Korsuva in the Orange Book expires November 12, 2032. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.