Orange Book product · Brand (NDA)
ZEGFROVY
SUNVOZERTINIB
At a glance
Jul 02, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 02, 2025
1 yr ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 02, 2030
in 4 yr 1 mo
Patent 11007198 expires
Listed drug substance patent expiration.
Jan 28, 2039
in 12 yr 10 mo
Patent 11504375 expires
Listed drug substance patent expiration.
Jan 28, 2039
in 12 yr 10 mo
Patent 11896597 expires
Listed drug substance patent expiration.
Jan 28, 2039
in 12 yr 10 mo
Pharmaceutical detail
Active ingredient
SUNVOZERTINIB
Strength
150MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219839
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
- NCENew chemical entity exclusivity (5 years)
Jul 02, 2030
in 4 yr 1 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11007198 | Jan 28, 2039 | in 12 yr 10 mo | SubstanceProduct |
| 11504375 | Jan 28, 2039 | in 12 yr 10 mo | SubstanceProductU-3220 |
| 11896597 | Jan 28, 2039 | in 12 yr 10 mo | SubstanceProductU-3220 |
