FDA Orange Book
Is there a generic for Viltepso?
Viltepso contains viltolarsen. 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 Viltepso (viltolarsen). The Orange Book shows its last listed patent expires April 3, 2034 and its last listed exclusivity ends August 12, 2027.
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Viltepso products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 250MG/5ML (50MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 212154, held by NIPPON SHINYAKU CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Viltepso patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10870676 | August 31, 2031 | Drug substance, Drug product | U-3039 | 212154 |
| 9079934 | April 3, 2034 | Drug substance, Drug product | None | 212154 |
Viltepso exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-280 | Orphan drug exclusivity | August 12, 2027 | 212154 |
Viltepso NDC codes
Questions
Is there a generic for Viltepso?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Viltepso (viltolarsen). The Orange Book shows its last listed patent expires April 3, 2034 and its last listed exclusivity ends August 12, 2027.
What is the generic name for Viltepso?
The active ingredient in Viltepso is viltolarsen, per the FDA Orange Book.
When does the Viltepso patent expire?
The last patent listed for Viltepso in the Orange Book expires April 3, 2034. 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.