Orange Book product · Brand (NDA)
GOMEKLI
MIRDAMETINIB
At a glance
Feb 11, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
19
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 11, 2025
1 yr 4 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Feb 11, 2030
in 3 yr 8 mo
Exclusivity ends · ODE-488
Orphan-drug exclusivity (7 years)
Feb 11, 2032
in 5 yr 9 mo
Patent 11066358 expires
Listed drug substance patent expiration.
Feb 17, 2041
in 14 yr 11 mo
Patent 11084780 expires
Listed drug substance patent expiration.
Feb 17, 2041
in 14 yr 11 mo
Patent 11453641 expires
Listed method-of-use patent (U-4130) expiration.
Feb 17, 2041
in 14 yr 11 mo
Patent 11806321 expires
Listed method-of-use patent (U-4130) expiration.
Feb 17, 2041
in 14 yr 11 mo
Patent 11819487 expires
Listed method-of-use patent (U-4130) expiration.
Feb 17, 2041
in 14 yr 11 mo
Patent 12011424 expires
Listed method-of-use patent (U-4130) expiration.
Feb 17, 2041
in 14 yr 11 mo
Patent 12037306 expires
Listed method-of-use patent (U-4130) expiration.
Feb 17, 2041
in 14 yr 11 mo
Patent 12263146 expires
Listed method-of-use patent (U-4130) expiration.
Feb 17, 2041
in 14 yr 11 mo
Patent 12275688 expires
Listed drug product patent expiration.
Feb 17, 2041
in 14 yr 11 mo
Patent 12295925 expires
Listed method-of-use patent (U-4130) expiration.
Feb 17, 2041
in 14 yr 11 mo
Patent 11839595 expires
Listed method-of-use patent (U-4130) expiration.
Mar 16, 2043
in 17 yr
Patent 11883375 expires
Listed method-of-use patent (U-4130) expiration.
Mar 16, 2043
in 17 yr
Patent 12220390 expires
Listed method-of-use patent (U-4130) expiration.
Mar 16, 2043
in 17 yr
Patent 12257215 expires
Listed method-of-use patent (U-4130) expiration.
Mar 16, 2043
in 17 yr
Patent 12324791 expires
Listed method-of-use patent (U-4130) expiration.
Mar 16, 2043
in 17 yr
Patent 11806322 expires
Listed method-of-use patent (U-4130) expiration.
Apr 09, 2043
in 17 yr 1 mo
Patent 12029711 expires
Listed drug product patent expiration.
Mar 15, 2044
in 18 yr
Patent 12383517 expires
Listed drug product patent expiration.
Mar 15, 2044
in 18 yr
Patent 12390430 expires
Listed method-of-use patent (U-4130) expiration.
Oct 10, 2044
in 18 yr 7 mo
Pharmaceutical detail
Active ingredient
MIRDAMETINIB
Strength
1MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 219389
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 (2)
- NCENew chemical entity exclusivity (5 years)
Feb 11, 2030
in 3 yr 8 mo
- ODE-488Orphan-drug exclusivity (7 years)
Feb 11, 2032
in 5 yr 9 mo
Listed patents (19)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11066358 | Feb 17, 2041 | in 14 yr 11 mo | Substance |
| 11084780 | Feb 17, 2041 | in 14 yr 11 mo | Substance |
| 11453641 | Feb 17, 2041 | in 14 yr 11 mo | U-4130 |
| 11806321 | Feb 17, 2041 | in 14 yr 11 mo | U-4130 |
| 11819487 | Feb 17, 2041 | in 14 yr 11 mo | U-4130 |
| 12011424 | Feb 17, 2041 | in 14 yr 11 mo | U-4130 |
| 12037306 | Feb 17, 2041 | in 14 yr 11 mo | U-4130 |
| 12263146 | Feb 17, 2041 | in 14 yr 11 mo | U-4130 |
| 12275688 | Feb 17, 2041 | in 14 yr 11 mo | ProductU-4130 |
| 12295925 | Feb 17, 2041 | in 14 yr 11 mo | U-4130 |
| 11839595 | Mar 16, 2043 | in 17 yr | U-4130 |
| 11883375 | Mar 16, 2043 | in 17 yr | U-4130 |
| 12220390 | Mar 16, 2043 | in 17 yr | U-4130 |
| 12257215 | Mar 16, 2043 | in 17 yr | U-4130 |
| 12324791 | Mar 16, 2043 | in 17 yr | U-4130 |
| 11806322 | Apr 09, 2043 | in 17 yr 1 mo | U-4130 |
| 12029711 | Mar 15, 2044 | in 18 yr | ProductU-4130 |
| 12383517 | Mar 15, 2044 | in 18 yr | ProductU-4130 |
| 12390430 | Oct 10, 2044 | in 18 yr 7 mo | U-4130 |
