Orange Book product · Brand (NDA)
HERNEXEOS
ZONGERTINIB
At a glance
Aug 08, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 08, 2025
11 mo ago
Today
Patent 12171739 expires
Listed drug substance patent expiration.
Nov 15, 2026
in 5 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 08, 2030
in 4 yr 2 mo
Patent 11608343 expires
Listed drug substance patent expiration.
Jul 21, 2041
in 15 yr 4 mo
Pharmaceutical detail
Active ingredient
ZONGERTINIB
Strength
60MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219042
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)
- NCENew chemical entity exclusivity (5 years)
Aug 08, 2030
in 4 yr 2 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12171739 | Nov 15, 2026 | in 5 mo | SubstanceProduct |
| 11608343 | Jul 21, 2041 | in 15 yr 4 mo | SubstanceProductU-4245 |
