small molecule

GOMEKLI

MIRDAMETINIB

Loss of exclusivityOctober 2044latest FDA-listed patent expiry
CompanySPRINGWORKS THERAPEUTICS INC

Drug detail

Brand nameGOMEKLI
Active ingredientMIRDAMETINIB
Strength4MG
Dosage formTABLET, FOR SUSPENSION
RouteORAL
ModalitySmall molecule
FDA approvalJuly 2026
Marketing statusRX

Listed patents

PatentExpiresType
12390430October 2044use U-4130
12029711March 2044product
12661330February 2044use U-4130
12324791March 2043use U-4591
12220390March 2043use U-4130
12357597February 2041use U-4130
11453641February 2041use U-4130
11066358February 2041substance, product
11571402February 2041product
12295925February 2041use U-4590
11084780February 2041substance
12037306February 2041use U-4130
12263146February 2041use U-4130
11819487February 2041use U-4590
11806321February 2041use U-4130

Regulatory exclusivity

CodeExpires
ODE*February 2032
NCEFebruary 2030

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.