FDA Orange Book
Is there a generic for Vyondys?
Vyondys contains golodirsen. 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 Vyondys (golodirsen). The Orange Book shows its last listed patent expires June 28, 2028 and its last listed exclusivity ends December 12, 2026.
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Vyondys products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 100MG/2ML (50MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 211970, held by SAREPTA THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vyondys patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE47691 | June 28, 2028 | Drug product | None | 211970 |
Vyondys exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-280 | Orphan drug exclusivity | December 12, 2026 | 211970 |
Vyondys NDC codes
Questions
Is there a generic for Vyondys?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vyondys (golodirsen). The Orange Book shows its last listed patent expires June 28, 2028 and its last listed exclusivity ends December 12, 2026.
What is the generic name for Vyondys?
The active ingredient in Vyondys is golodirsen, per the FDA Orange Book.
When does the Vyondys patent expire?
The last patent listed for Vyondys in the Orange Book expires June 28, 2028. 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.