Orange Book product · Brand (NDA)
COTELLIC
COBIMETINIB FUMARATE
At a glance
Nov 10, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 10, 2015
10 yr 9 mo ago
Exclusivity ends · M-278
New use / labeling-change exclusivity (3 years)
Jul 28, 2025
11 mo ago
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jan 28, 2026
5 mo ago
Today
Patent 11597699 expires
Listed method-of-use patent (U-3554) expiration.
Oct 05, 2026
in 4 mo
Patent 8362002 expires
Listed method-of-use patent (U-1776) expiration.
Oct 05, 2026
in 4 mo
Patent 8362002*PED expires
Listed listed patent expiration.
Apr 05, 2027
in 10 mo
Exclusivity ends · ODE-416
Orphan-drug exclusivity (7 years)
Oct 28, 2029
in 3 yr 5 mo
Patent 7803839 expires
Listed drug substance patent expiration.
Nov 10, 2029
in 3 yr 5 mo
Patent 7803839*PED expires
Listed listed patent expiration.
May 10, 2030
in 3 yr 11 mo
Patent 11087354 expires
Listed method-of-use patent (U-1776) expiration.
Jun 22, 2034
in 8 yr 2 mo
Patent 11087354*PED expires
Listed listed patent expiration.
Dec 22, 2034
in 8 yr 8 mo
Patent 10478400 expires
Listed drug substance patent expiration.
Jun 29, 2036
in 10 yr 2 mo
Patent 10590102 expires
Listed drug substance patent expiration.
Jun 30, 2036
in 10 yr 2 mo
Patent 11254649 expires
Listed drug substance patent expiration.
Jun 30, 2036
in 10 yr 2 mo
Patent 10478400*PED expires
Listed listed patent expiration.
Dec 29, 2036
in 10 yr 8 mo
Patent 10590102*PED expires
Listed listed patent expiration.
Dec 30, 2036
in 10 yr 8 mo
Patent 11254649*PED expires
Listed listed patent expiration.
Dec 30, 2036
in 10 yr 8 mo
Pharmaceutical detail
Active ingredient
COBIMETINIB FUMARATE
Strength
EQ 20MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 206192
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 (3)
- M-278New use / labeling-change exclusivity (3 years)
Jul 28, 2025
11 mo ago
- PEDPediatric exclusivity (adds 6 months)
Jan 28, 2026
5 mo ago
- ODE-416Orphan-drug exclusivity (7 years)
Oct 28, 2029
in 3 yr 5 mo
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11597699 | Oct 05, 2026 | in 4 mo | U-3554 |
| 8362002 | Oct 05, 2026 | in 4 mo | U-1776 |
| 8362002*PED | Apr 05, 2027 | in 10 mo | |
| 7803839 | Nov 10, 2029 | in 3 yr 5 mo | SubstanceProduct |
| 7803839*PED | May 10, 2030 | in 3 yr 11 mo | |
| 11087354 | Jun 22, 2034 | in 8 yr 2 mo | U-1776 |
| 11087354*PED | Dec 22, 2034 | in 8 yr 8 mo | |
| 10478400 | Jun 29, 2036 | in 10 yr 2 mo | SubstanceProductU-1776 |
| 10590102 | Jun 30, 2036 | in 10 yr 2 mo | SubstanceProductU-1776 |
| 11254649 | Jun 30, 2036 | in 10 yr 2 mo | SubstanceProductU-1776 |
| 10478400*PED | Dec 29, 2036 | in 10 yr 8 mo | |
| 10590102*PED | Dec 30, 2036 | in 10 yr 8 mo | |
| 11254649*PED | Dec 30, 2036 | in 10 yr 8 mo |
