FDA Orange Book
Is there a generic for Gomekli?
Gomekli contains mirdametinib. 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 Gomekli (mirdametinib). The Orange Book shows its last listed patent expires October 10, 2044 and its last listed exclusivity ends February 11, 2032.
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Gomekli products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 1MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 2MG | Marketed (Rx) | None | 0 | None |
| tablet, for suspension, oral | 1MG | Marketed (Rx) | None | 0 | None |
| tablet, for suspension, oral | 3MG | Marketed (Rx) | None | 0 | None |
| tablet, for suspension, oral | 4MG | Marketed (Rx) | None | 0 | None |
NDA 219389, 219379, held by SPRINGWORKS THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Gomekli patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11806321 | February 17, 2041 | Method of use | U-4130 | 219389 |
| 11453641 | February 17, 2041 | Method of use | U-4130 | 219389 |
| 12263146 | February 17, 2041 | Method of use | U-4130 | 219389 |
| 12275688 | February 17, 2041 | Drug product | U-4130 | 219389 |
| 12037306 | February 17, 2041 | Method of use | U-4130 | 219389 |
| 12295925 | February 17, 2041 | Method of use | U-4590 | 219389 |
| 12011424 | February 17, 2041 | Method of use | U-4595 | 219389 |
| 11819487 | February 17, 2041 | Method of use | U-4590 | 219389 |
| 11066358 | February 17, 2041 | Drug substance | None | 219389 |
| 11084780 | February 17, 2041 | Drug substance | None | 219389 |
| 12357597 | February 17, 2041 | Method of use | U-4130 | 219379 |
| 12090128 | February 17, 2041 | Drug product | U-4130 | 219379 |
| 11571402 | February 17, 2041 | Drug product | None | 219379 |
| 11883375 | March 16, 2043 | Method of use | U-4130 | 219389 |
| 11839595 | March 16, 2043 | Method of use | U-4130 | 219389 |
| 12257215 | March 16, 2043 | Method of use | U-4130 | 219389 |
| 12220390 | March 16, 2043 | Method of use | U-4130 | 219389 |
| 12324791 | March 16, 2043 | Method of use | U-4591 | 219389 |
| 11806322 | April 9, 2043 | Method of use | U-4130 | 219389 |
| 12661330 | February 5, 2044 | Method of use | U-4130 | 219389 |
| 12383517 | March 15, 2044 | Drug product | U-4130 | 219389 |
| 12029711 | March 15, 2044 | Drug product | U-4130 | 219389 |
| 12390430 | October 10, 2044 | Method of use | U-4130 | 219389 |
Gomekli exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 11, 2030 | 219389 |
| ODE-488 | Orphan drug exclusivity | February 11, 2032 | 219389 |
| ODE* | See the Orange Book exclusivity code list | February 11, 2032 | 219379 |
Gomekli NDC codes
Questions
Is there a generic for Gomekli?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gomekli (mirdametinib). The Orange Book shows its last listed patent expires October 10, 2044 and its last listed exclusivity ends February 11, 2032.
What is the generic name for Gomekli?
The active ingredient in Gomekli is mirdametinib, per the FDA Orange Book.
When does the Gomekli patent expire?
The last patent listed for Gomekli in the Orange Book expires October 10, 2044. 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.