Orange Book product · Brand (NDA)
ROMVIMZA
VIMSELTINIB
At a glance
Feb 14, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 14, 2025
1 yr 4 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Feb 14, 2030
in 3 yr 9 mo
Patent 9181223 expires
Listed drug substance patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 12285430 expires
Listed method-of-use patent (U-4145) expiration.
Dec 23, 2039
in 13 yr 9 mo
Patent 12485120 expires
Listed method-of-use patent (U-4145) expiration.
Dec 23, 2039
in 13 yr 9 mo
Patent 12582655 expires
Listed method-of-use patent (U-4145) expiration.
Dec 23, 2039
in 13 yr 9 mo
Patent 11103507 expires
Listed method-of-use patent (U-4145) expiration.
Feb 03, 2040
in 13 yr 10 mo
Patent 11679110 expires
Listed method-of-use patent (U-4145) expiration.
Feb 03, 2040
in 13 yr 10 mo
Patent 12447149 expires
Listed drug product patent expiration.
Dec 06, 2044
in 18 yr 9 mo
Patent 12528787 expires
Listed drug substance patent expiration.
Dec 06, 2044
in 18 yr 9 mo
Patent 12551483 expires
Listed drug product patent expiration.
Dec 06, 2044
in 18 yr 9 mo
Patent 12617775 expires
Listed drug substance patent expiration.
Dec 06, 2044
in 18 yr 9 mo
Patent 12643883 expires
Listed drug substance patent expiration.
Dec 06, 2044
in 18 yr 9 mo
Patent 12509443 expires
Listed drug product patent expiration.
Apr 30, 2045
in 19 yr 2 mo
Pharmaceutical detail
Active ingredient
VIMSELTINIB
Strength
14MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 219304
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)
Feb 14, 2030
in 3 yr 9 mo
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9181223 | Mar 14, 2034 | in 7 yr 10 mo | SubstanceProduct |
| 12285430 | Dec 23, 2039 | in 13 yr 9 mo | U-4145 |
| 12485120 | Dec 23, 2039 | in 13 yr 9 mo | U-4145 |
| 12582655 | Dec 23, 2039 | in 13 yr 9 mo | U-4145 |
| 11103507 | Feb 03, 2040 | in 13 yr 10 mo | U-4145 |
| 11679110 | Feb 03, 2040 | in 13 yr 10 mo | U-4145 |
| 12447149 | Dec 06, 2044 | in 18 yr 9 mo | Product |
| 12528787 | Dec 06, 2044 | in 18 yr 9 mo | SubstanceProduct |
| 12551483 | Dec 06, 2044 | in 18 yr 9 mo | Product |
| 12617775 | Dec 06, 2044 | in 18 yr 9 mo | SubstanceProduct |
| 12643883 | Dec 06, 2044 | in 18 yr 9 mo | SubstanceProduct |
| 12509443 | Apr 30, 2045 | in 19 yr 2 mo | Product |

