FDA Orange Book
Generic for Vykoura
Vykoura contains leucovorin. 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 Vykoura is leucovorin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 3 Vykoura products the Orange Book lists.
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Vykoura products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intramuscular, intravenous | EQ 350MG BASE/35ML (EQ 10MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, intramuscular, intravenous | EQ 500MG BASE/50ML (EQ 10MG BASE/ML) | Marketed (Rx) | None | 1 | None |
| solution, intramuscular, intravenous | EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 220406, held by AVYXA HOLDINGS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic leucovorin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 207226 | None (No TE code listed) | July 27, 2018 | EQ 500MG BASE/50ML (EQ 10MG BASE/ML) |
Vykoura patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12564592 | December 23, 2044 | Drug product | None | 220406 |
Vykoura NDC codes
Questions
Is there a generic for Vykoura?
Yes. The generic name for Vykoura is leucovorin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 3 Vykoura products the Orange Book lists.
What is the generic name for Vykoura?
The active ingredient in Vykoura is leucovorin, per the FDA Orange Book.
When does the Vykoura patent expire?
The last patent listed for Vykoura in the Orange Book expires December 23, 2044. 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.