FDA Orange Book
Is there a generic for Mekinist?
Mekinist contains trametinib dimethyl sulfoxide. 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 Mekinist (trametinib dimethyl sulfoxide). The Orange Book shows its last listed patent expires February 28, 2034 and its last listed exclusivity ends September 16, 2030.
Run it in Rivvi
Map Mekinist and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Mekinist products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | EQ 0.05MG BASE/ML | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 0.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 1MG | Discontinued | None | 0 | None |
| tablet, oral | EQ 2MG | Marketed (Rx) | None | 0 | None |
NDA 217513, 204114, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Mekinist patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7378423 | May 29, 2027 | Drug substance, Drug product | None | 217513 |
| 7378423*PED | November 29, 2027 | Method of use | None | 217513 |
| 8703781 | October 15, 2030 | Drug substance, Drug product | U-3564 | 217513 |
| 8703781 | October 15, 2030 | Drug substance, Drug product | U-2305 | 204114 |
| 8703781 | October 15, 2030 | Drug substance, Drug product | U-1712 | 204114 |
| 8703781 | October 15, 2030 | Drug substance, Drug product | U-2020 | 204114 |
| 8952018 | October 15, 2030 | Method of use | U-2020 | 204114 |
| 8703781 | October 15, 2030 | Drug substance, Drug product | U-2302 | 204114 |
| 8703781 | October 15, 2030 | Drug substance, Drug product | U-2037 | 204114 |
| 8703781*PED | April 15, 2031 | Method of use | None | 217513 |
| 8952018*PED | April 15, 2031 | Method of use | None | 204114 |
| 8580304 | January 28, 2032 | Drug product | None | 204114 |
| 9399021 | January 28, 2032 | Drug product | None | 204114 |
| 9155706 | January 28, 2032 | Drug product | None | 204114 |
| 9271941 | January 28, 2032 | Drug product | None | 204114 |
| 8580304*PED | July 28, 2032 | Method of use | None | 204114 |
| 9155706*PED | July 28, 2032 | Method of use | None | 204114 |
| 9271941*PED | July 28, 2032 | Method of use | None | 204114 |
| 9399021*PED | July 28, 2032 | Method of use | None | 204114 |
| 10869869 | August 30, 2033 | Method of use | U-3184 | 204114 |
| 10869869*PED | February 28, 2034 | Method of use | None | 204114 |
Mekinist exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | March 16, 2026 | 217513 |
| I-908 | New indication | March 16, 2026 | 204114 |
| PED | Pediatric exclusivity | September 16, 2026 | 217513 |
| ODE-428 | Orphan drug exclusivity | March 16, 2030 | 217513 |
| PED | Pediatric exclusivity | September 16, 2030 | 217513 |
Mekinist NDC codes
Questions
Is there a generic for Mekinist?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mekinist (trametinib dimethyl sulfoxide). The Orange Book shows its last listed patent expires February 28, 2034 and its last listed exclusivity ends September 16, 2030.
What is the generic name for Mekinist?
The active ingredient in Mekinist is trametinib dimethyl sulfoxide, per the FDA Orange Book.
When does the Mekinist patent expire?
The last patent listed for Mekinist in the Orange Book expires February 28, 2034. 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.