FDA Orange Book
Is there a generic for Vigafyde?
Vigafyde contains vigabatrin. 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 Vigafyde (vigabatrin). The Orange Book shows its last listed patent expires June 8, 2043.
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Vigafyde products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 100MG/ML | Marketed (Rx) | None | 0 | None |
NDA 217684, held by PYROS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vigafyde patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12016857 | August 16, 2039 | Drug product | None | 217684 |
| 12290499 | October 17, 2042 | Drug product | None | 217684 |
| 12576054 | June 8, 2043 | Drug product | None | 217684 |
Vigafyde NDC codes
Questions
Is there a generic for Vigafyde?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vigafyde (vigabatrin). The Orange Book shows its last listed patent expires June 8, 2043.
What is the generic name for Vigafyde?
The active ingredient in Vigafyde is vigabatrin, per the FDA Orange Book.
When does the Vigafyde patent expire?
The last patent listed for Vigafyde in the Orange Book expires June 8, 2043. 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.