FDA Orange Book
Is there a generic for Vyalev?
Vyalev contains foscarbidopa and foslevodopa. 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 Vyalev (foscarbidopa and foslevodopa). The Orange Book shows its last listed patent expires June 10, 2040 and its last listed exclusivity ends October 16, 2027.
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Vyalev products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 216962, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vyalev patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9446059 | October 21, 2035 | Drug substance, Drug product | U-4030 | 216962 |
| 10174061 | October 21, 2035 | Drug product | U-4030 | 216962 |
| 10730895 | October 21, 2035 | Drug substance | None | 216962 |
| 12251365 | June 10, 2040 | Method of use | U-4030 | 216962 |
Vyalev exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | October 16, 2027 | 216962 |
Vyalev NDC codes
Questions
Is there a generic for Vyalev?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vyalev (foscarbidopa and foslevodopa). The Orange Book shows its last listed patent expires June 10, 2040 and its last listed exclusivity ends October 16, 2027.
What is the generic name for Vyalev?
The active ingredient in Vyalev is foscarbidopa and foslevodopa, per the FDA Orange Book.
When does the Vyalev patent expire?
The last patent listed for Vyalev in the Orange Book expires June 10, 2040. 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.