FDA Orange Book · active-ingredient family
Mirdametinib
Mirdametinib: 2 brands, 0 generics; first approved Feb 11, 2025; on patent until Feb 17, 2041.
On patent6 exclusivity periods
Generic status & protection
Protected until Feb 17, 2041 (earliest listed patent expiry).
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
0
Listed patents
23
Next patent expiry
Feb 17, 2041
in 14 yr 8 mo
Brand (NDA) products
Originator applications
- GOMEKLIRLDSPRINGWORKSNDA 21938920252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG CAPSULE ORAL Rx — 2MG CAPSULE ORAL Rx — - SPRINGWORKSNDA 21937920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET, FOR SUSPENSION ORAL Rx — 3MG TABLET, FOR SUSPENSION ORAL Rx — 4MG TABLET, FOR SUSPENSION ORAL Rx —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NCENew chemical entity exclusivity (5 years)
in 3 yr 5 mo
- ODE-488Orphan-drug exclusivity (7 years)
in 5 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
in 3 yr 5 mo
- ODE-488Orphan-drug exclusivity (7 years)
in 5 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
in 3 yr 5 mo
- ODE-488Orphan-drug exclusivity (7 years)
in 5 yr 6 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12295925 | in 14 yr 8 mo | U-4130 | |
| 12011424 | in 14 yr 8 mo | U-4130 | |
| 11819487 | in 14 yr 8 mo | U-4130 | |
| 11806321 | in 14 yr 8 mo | U-4130 | |
| 11453641 | in 14 yr 8 mo | U-4130 | |
| 12263146 | in 14 yr 8 mo | U-4130 | |
| 12275688 | in 14 yr 8 mo | ProductU-4130 | |
| 12037306 | in 14 yr 8 mo | U-4130 | |
| 11066358 | in 14 yr 8 mo | Substance | |
| 11084780 | in 14 yr 8 mo | Substance | |
| 12357597 | in 14 yr 8 mo | U-4130 | |
| 12090128 | in 14 yr 8 mo | ProductU-4130 | |
| 11571402 | in 14 yr 8 mo | Product | |
| 11883375 | in 16 yr 9 mo | U-4130 | |
| 12324791 | in 16 yr 9 mo | U-4130 | |
| 11839595 | in 16 yr 9 mo | U-4130 | |
| 12257215 | in 16 yr 9 mo | U-4130 | |
| 12220390 | in 16 yr 9 mo | U-4130 | |
| 11806322 | in 16 yr 10 mo | U-4130 | |
| 12661330 | in 17 yr 8 mo | U-4130 | |
| 12383517 | in 17 yr 9 mo | ProductU-4130 | |
| 12029711 | in 17 yr 9 mo | ProductU-4130 | |
| 12390430 | in 18 yr 4 mo | U-4130 |
Approval history
FDA approval span
First approval
1 yr 7 mo ago
Most recent approval
2 mo ago
Approvals span 2025–2026 across 2 FDA applications.
Brand (NDA) 2100%
Generic (ANDA) 00%
Mirdametinib: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
