Dacomitinib

2 API suppliersSmall Molecule

Overview

Dacomitinib is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL2105719).

API suppliers (2)

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

Where these suppliers are
India1China1

1 of 2 holds a GMP certificate on record in the EU or UK registers

Patent & exclusivity (US)

Per the FDA Orange Book (3 approved US products), the latest listed US patent on Dacomitinib expires 27 Sept 2032. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name
(E)-N-[4-(3-chloro-4-fluoroanilino)-7-methoxyquinazolin-6-yl]-4-piperidin-1-ylbut-2-enamide;hydrate
Canonical SMILES
COC1=C(C=C2C(=C1)N=CN=C2NC3=CC(=C(C=C3)F)Cl)NC(=O)/C=C/CN4CCCCC4.O
InChIKey
BSPLGGCPNTZPIH-IPZCTEOASA-N
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