FDA Orange Book
Is there a generic for Cotellic?
Cotellic contains cobimetinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cotellic (cobimetinib). The Orange Book shows its last listed patent expires December 30, 2036 and its last listed exclusivity ends October 28, 2029.
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Cotellic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
NDA 206192, held by GENENTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cotellic patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8362002 | October 5, 2026 | Method of use | U-1776 | 206192 |
| 11597699 | October 5, 2026 | Method of use | U-3554 | 206192 |
| 8362002*PED | April 5, 2027 | Method of use | None | 206192 |
| 7803839 | November 10, 2029 | Drug substance, Drug product | None | 206192 |
| 7803839*PED | May 10, 2030 | Method of use | None | 206192 |
| 11087354 | June 22, 2034 | Method of use | U-1776 | 206192 |
| 11087354*PED | December 22, 2034 | Method of use | None | 206192 |
| 10478400 | June 29, 2036 | Drug substance, Drug product | U-1776 | 206192 |
| 10590102 | June 30, 2036 | Drug substance, Drug product | U-1776 | 206192 |
| 11254649 | June 30, 2036 | Drug substance, Drug product | U-1776 | 206192 |
| 10478400*PED | December 29, 2036 | Method of use | None | 206192 |
| 11254649*PED | December 30, 2036 | Method of use | None | 206192 |
| 10590102*PED | December 30, 2036 | Method of use | None | 206192 |
Cotellic exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-278 | Miscellaneous | July 28, 2025 | 206192 |
| PED | Pediatric exclusivity | January 28, 2026 | 206192 |
| ODE-416 | Orphan drug exclusivity | October 28, 2029 | 206192 |
Cotellic NDC codes
Questions
Is there a generic for Cotellic?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cotellic (cobimetinib). The Orange Book shows its last listed patent expires December 30, 2036 and its last listed exclusivity ends October 28, 2029.
What is the generic name for Cotellic?
The active ingredient in Cotellic is cobimetinib, per the FDA Orange Book.
When does the Cotellic patent expire?
The last patent listed for Cotellic in the Orange Book expires December 30, 2036. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.