Orange Book product · Brand (NDA)
RHAPSIDO
REMIBRUTINIB
At a glance
Sep 30, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 30, 2025
9 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 30, 2030
in 4 yr 4 mo
Patent 10457647 expires
Listed method-of-use patent (U-4280) expiration.
Nov 13, 2034
in 8 yr 6 mo
Patent 9512084 expires
Listed drug substance patent expiration.
Nov 13, 2034
in 8 yr 6 mo
Patent 12419889 expires
Listed method-of-use patent (U-4281) expiration.
Jan 19, 2043
in 16 yr 10 mo
Pharmaceutical detail
Active ingredient
REMIBRUTINIB
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 218436
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)
Sep 30, 2030
in 4 yr 4 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10457647 | Nov 13, 2034 | in 8 yr 6 mo | U-4280 |
| 9512084 | Nov 13, 2034 | in 8 yr 6 mo | SubstanceProduct |
| 12419889 | Jan 19, 2043 | in 16 yr 10 mo | U-4281 |
