Orange Book product · Brand (NDA)
HYRNUO
SEVABERTINIB
Brand (NDA)NDA 219972RX BAYER HEALTHCARE
At a glance
Nov 19, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 19, 2025
7 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 19, 2030
in 4 yr 6 mo
Patent 10428063 expires
Listed drug substance patent expiration.
Oct 10, 2035
in 9 yr 5 mo
Pharmaceutical detail
Active ingredient
SEVABERTINIB
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219972
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)
Nov 19, 2030
in 4 yr 6 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10428063 | Oct 10, 2035 | in 9 yr 5 mo | SubstanceProduct |
