Itraconazole

Overview

Itraconazole is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL64391).

API suppliers (14)

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

• QUIMICA SINTETICA SASpain1 active DMF GMP on record
• MATRIX PHARMACORP PRIVATE LTDIndia1 active DMF
• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• Neuland Laboratories LimitedIndia1 active DMF
• SMS Pharmaceuticals limitedIndia1 active DMF GMP on record
• COHANCE LIFESCIENCES LTDIndia1 active DMF GMP on record
• VASUDHA PHARMA CHEM LTDIndia1 active DMF
• LEE PHARMA LTDIndia1 active DMF GMP on record
• W R GRACE AND CO -CONNUnited States1 active DMF
• Hetero Drugs LimitedIndia GMP on record
• SOCIETA ITALIANA MEDICINALI SCANDICCI
• QUIMICA FINA FARMEX SA DE CV
• PIRAMAL HEALTHCARE LTD
• APOTECNIA SA

Patent & exclusivity (US)

Per the FDA Orange Book (11 approved US products), the latest listed US patent on Itraconazole expires 21 Jun 2033. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

2-butan-2-yl-4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one

Canonical SMILES

CCC(C)N1C(=O)N(C=N1)C2=CC=C(C=C2)N3CCN(CC3)C4=CC=C(C=C4)OCC5COC(O5)(CN6C=NC=N6)C7=C(C=C(C=C7)Cl)Cl

InChIKey

VHVPQPYKVGDNFY-UHFFFAOYSA-N