Orange Book product · Brand (NDA)
VYALEV
FOSCARBIDOPA; FOSLEVODOPA
At a glance
Oct 16, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 16, 2024
1 yr 8 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Oct 16, 2027
in 1 yr 4 mo
Patent 10174061 expires
Listed drug product patent expiration.
Oct 21, 2035
in 9 yr 6 mo
Patent 10730895 expires
Listed drug substance patent expiration.
Oct 21, 2035
in 9 yr 6 mo
Patent 9446059 expires
Listed drug substance patent expiration.
Oct 21, 2035
in 9 yr 6 mo
Patent 12251365 expires
Listed method-of-use patent (U-4030) expiration.
Jun 10, 2040
in 14 yr 2 mo
Pharmaceutical detail
Active ingredient
FOSCARBIDOPA; FOSLEVODOPA
Strength
120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 216962
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Oct 16, 2027
in 1 yr 4 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10174061 | Oct 21, 2035 | in 9 yr 6 mo | ProductU-4030 |
| 10730895 | Oct 21, 2035 | in 9 yr 6 mo | Substance |
| 9446059 | Oct 21, 2035 | in 9 yr 6 mo | SubstanceProductU-4030 |
| 12251365 | Jun 10, 2040 | in 14 yr 2 mo | U-4030 |
