small molecule

AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)

AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE

Loss of exclusivityDecember 2042latest FDA-listed patent expiry
CompanyVerastem →See this company's full patent-cliff portfolio

Drug detail

Brand nameAVMAPKI FAKZYNJA CO-PACK (COPACKAGED)
Active ingredientAVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
StrengthEQ 0.8MG BASE;EQ 200MG BASE
Dosage formCAPSULE, TABLET
RouteORAL
ModalitySmall molecule
FDA approvalMay 2025
Marketing statusRX

Listed patents

PatentExpiresType
12509450December 2042product
11873296December 2042product
11517573September 2040use U-4205
11400090October 2038use U-4196
7928109August 2029substance, product
8247411April 2028substance, product
7897792February 2027substance, product

Regulatory exclusivity

CodeExpires
ODE-525May 2032
NCEMay 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.