FDA Orange Book
Is there a generic for Vafseo?
Vafseo contains vadadustat. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vafseo (vadadustat). The Orange Book shows its last listed patent expires March 31, 2036 and its last listed exclusivity ends March 27, 2029.
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Vafseo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 300MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 450MG | Discontinued | None | 0 | None |
NDA 215192, held by AKEBIA THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vafseo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8940773 | June 26, 2027 | Method of use | U-3876 | 215192 |
| RE47437 | June 26, 2027 | Drug substance, Drug product | None | 215192 |
| 8598210 | June 26, 2027 | Drug substance, Drug product | None | 215192 |
| 8343952 | August 14, 2027 | Drug substance, Drug product | None | 215192 |
| 7811595 | March 13, 2028 | Drug substance, Drug product | None | 215192 |
| 8323671 | April 3, 2028 | Method of use | U-3876 | 215192 |
| 12569474 | June 4, 2034 | Method of use | U-3876 | 215192 |
| 11857543 | June 9, 2034 | Method of use | U-3876 | 215192 |
| 11065237 | November 14, 2034 | Drug substance, Drug product | U-3876 | 215192 |
| 9987262 | November 14, 2034 | Method of use | U-3876 | 215192 |
| 9701636 | November 14, 2034 | Drug substance, Drug product | None | 215192 |
| 10149842 | November 14, 2034 | Drug substance, Drug product | None | 215192 |
| 11844756 | March 31, 2036 | Method of use | U-3876 | 215192 |
| 11324734 | March 31, 2036 | Drug product | None | 215192 |
Vafseo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 27, 2029 | 215192 |
Vafseo NDC codes
Questions
Is there a generic for Vafseo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vafseo (vadadustat). The Orange Book shows its last listed patent expires March 31, 2036 and its last listed exclusivity ends March 27, 2029.
What is the generic name for Vafseo?
The active ingredient in Vafseo is vadadustat, per the FDA Orange Book.
When does the Vafseo patent expire?
The last patent listed for Vafseo in the Orange Book expires March 31, 2036. 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.