small molecule

SCEMBLIX

ASCIMINIB HYDROCHLORIDE

Loss of exclusivityMay 2040latest FDA-listed patent expiry
CompanyNovartisSee this company's full patent-cliff portfolio

Drug detail

Brand nameSCEMBLIX
Active ingredientASCIMINIB HYDROCHLORIDE
StrengthEQ 40MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2021
Marketing statusRX

Listed patents

PatentExpiresType
12252479May 2040use U-1374
11407735May 2040substance
12252478May 2040product
8829195October 2035substance

Regulatory exclusivity

CodeExpires
ODE-499October 2031
ODE-500October 2031
ODE-381October 2028
ODE-382October 2028
M-318October 2028
I-953October 2027
I-954October 2027
NCEOctober 2026

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.

SCEMBLIX patent cliff — loss of exclusivity May 2040 | CliffBio