Osimertinib

Overview

Osimertinib is a third-generation tyrosine kinase inhibitor used in the treatment of non-small cell lung cancer (NSCLC) with specific mutations in the epidermal growth factor receptor (EGFR) gene. It is designed to target both the initial activating EGFR mutations and the T790M resistance mutation.

Patent & exclusivity (US)

Per the FDA Orange Book (2 approved US products), the latest listed US patent on Osimertinib expires 26 Nov 2042 and exclusivity 18 Dec 2027. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid

Canonical SMILES

CC(C)C1=NC(=NC(=C1C=CC(CC(CC(=O)O)O)O)C2=CC=C(C=C2)F)N(C)S(=O)(=O)C

InChIKey

BPRHUIZQVSMCRT-UHFFFAOYSA-N

Therapeutic areas