Orange Book product · Brand (NDA)
MEKTOVI
BINIMETINIB
At a glance
Jun 27, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 27, 2018
8 yr 1 mo ago
Today
Exclusivity ends · I-928
New indication exclusivity (3 years)
Oct 11, 2026
in 4 mo
Patent 7777050 expires
Listed drug substance patent expiration.
Mar 13, 2027
in 9 mo
Patent 10005761 expires
Listed method-of-use patent (U-2331) expiration.
Aug 27, 2030
in 4 yr 3 mo
Patent 10005761 expires
Listed method-of-use patent (U-3737) expiration.
Aug 27, 2030
in 4 yr 3 mo
Patent 9850229 expires
Listed method-of-use patent (U-2333) expiration.
Aug 27, 2030
in 4 yr 3 mo
Patent 9314464 expires
Listed method-of-use patent (U-2332) expiration.
Jul 04, 2031
in 5 yr 1 mo
Patent 9314464 expires
Listed method-of-use patent (U-3737) expiration.
Jul 04, 2031
in 5 yr 1 mo
Patent 9562016 expires
Listed drug substance patent expiration.
Oct 18, 2033
in 7 yr 5 mo
Patent 9598376 expires
Listed method-of-use patent (U-2330) expiration.
Oct 18, 2033
in 7 yr 5 mo
Patent 9980944 expires
Listed method-of-use patent (U-2334) expiration.
Oct 18, 2033
in 7 yr 5 mo
Pharmaceutical detail
Active ingredient
BINIMETINIB
Strength
15MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 210498
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)
- I-928New indication exclusivity (3 years)
Oct 11, 2026
in 4 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7777050 | Mar 13, 2027 | in 9 mo | SubstanceProduct |
| 10005761 | Aug 27, 2030 | in 4 yr 3 mo | U-2331 |
| 10005761 | Aug 27, 2030 | in 4 yr 3 mo | U-3737 |
| 9850229 | Aug 27, 2030 | in 4 yr 3 mo | U-2333 |
| 9314464 | Jul 04, 2031 | in 5 yr 1 mo | U-2332 |
| 9314464 | Jul 04, 2031 | in 5 yr 1 mo | U-3737 |
| 9562016 | Oct 18, 2033 | in 7 yr 5 mo | SubstanceProduct |
| 9598376 | Oct 18, 2033 | in 7 yr 5 mo | U-2330 |
| 9980944 | Oct 18, 2033 | in 7 yr 5 mo | U-2334 |

