FDA Orange Book
Is there a generic for Vistogard?
Vistogard contains uridine triacetate. 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 Vistogard (uridine triacetate). The Orange Book shows its last listed patent expires August 17, 2027.
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Vistogard products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| granule, oral | 10GM/PACKET | Marketed (Rx) | None | 0 | None |
NDA 208159, held by BTG INTERNATIONAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vistogard patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7776838 | August 17, 2027 | Method of use | U-1791 | 208159 |
Vistogard NDC codes
Questions
Is there a generic for Vistogard?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vistogard (uridine triacetate). The Orange Book shows its last listed patent expires August 17, 2027.
What is the generic name for Vistogard?
The active ingredient in Vistogard is uridine triacetate, per the FDA Orange Book.
When does the Vistogard patent expire?
The last patent listed for Vistogard in the Orange Book expires August 17, 2027. 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.