Difamilast

Overview

Difamilast is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL3989968).

API suppliers (1)

Suppliers of Difamilast evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• HEFEI TIANRUI PHARMACEUTICAL CHEMICAL CO LTDChina1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (1 approved US product), the latest listed US patent on Difamilast expires 31 Dec 2036 and exclusivity 12 Feb 2031. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

N-[[2-[4-(difluoromethoxy)-3-propan-2-yloxyphenyl]-1,3-oxazol-4-yl]methyl]-2-ethoxybenzamide

Canonical SMILES

CCOC1=CC=CC=C1C(=O)NCC2=COC(=N2)C3=CC(=C(C=C3)OC(F)F)OC(C)C

InChIKey

VFBILHPIHUPBPZ-UHFFFAOYSA-N