Neratinib

Overview

Neratinib is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL180022).

API suppliers (2)

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

• MSN Laboratories Private LimitedIndia1 active DMF GMP on record
• TAPI NL BVNetherlands1 active DMF

Patent & exclusivity (US)

Per the FDA Orange Book (1 approved US product), the latest listed US patent on Neratinib expires 18 Jul 2031. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

(E)-N-[4-[3-chloro-4-(pyridin-2-ylmethoxy)anilino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide

Canonical SMILES

CCOC1=C(C=C2C(=C1)N=CC(=C2NC3=CC(=C(C=C3)OCC4=CC=CC=N4)Cl)C#N)NC(=O)/C=C/CN(C)C

InChIKey

JWNPDZNEKVCWMY-VQHVLOKHSA-N