FDA Orange Book
Is there a generic for Mektovi?
Mektovi contains binimetinib. 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 Mektovi (binimetinib). The Orange Book shows its last listed patent expires October 18, 2033 and its last listed exclusivity ends October 11, 2026.
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Mektovi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 15MG | Marketed (Rx) | None | 0 | None |
NDA 210498, held by ARRAY BIOPHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Mektovi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7777050 | March 13, 2027 | Drug substance, Drug product | None | 210498 |
| 10005761 | August 27, 2030 | Method of use | U-2331 | 210498 |
| 9850229 | August 27, 2030 | Method of use | U-2333 | 210498 |
| 10005761 | August 27, 2030 | Method of use | U-3737 | 210498 |
| 9314464 | July 4, 2031 | Method of use | U-2332 | 210498 |
| 9314464 | July 4, 2031 | Method of use | U-3737 | 210498 |
| 9980944 | October 18, 2033 | Method of use | U-2334 | 210498 |
| 9598376 | October 18, 2033 | Method of use | U-2330 | 210498 |
| 9562016 | October 18, 2033 | Drug substance, Drug product | None | 210498 |
Mektovi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-928 | New indication | October 11, 2026 | 210498 |
Mektovi NDC codes
Questions
Is there a generic for Mektovi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mektovi (binimetinib). The Orange Book shows its last listed patent expires October 18, 2033 and its last listed exclusivity ends October 11, 2026.
What is the generic name for Mektovi?
The active ingredient in Mektovi is binimetinib, per the FDA Orange Book.
When does the Mektovi patent expire?
The last patent listed for Mektovi in the Orange Book expires October 18, 2033. 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.