Ivacaftor

Overview

Ivacaftor is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL2010601).

API suppliers (11)

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

• ALIVUS LIFE SCIENCES LTDIndia1 active DMF GMP on record
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• LUPIN MANUFACTURING SOLUTIONS LTD1 active DMF
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• APITORIA PHARMA PRIVATE LTDIndia1 active DMF GMP on record
• Cipla USA, Inc.USA1 active DMF
• MEDICHEM SASpain1 active DMF GMP on record
• Biocon LimitedIndia1 active DMF
• Zydus Lifesciences LimitedIndia1 active DMF GMP on record
• MAITHRI DRUGS PRIVATE LTDIndia1 active DMF GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (6 approved US products), the latest listed US patent on Ivacaftor expires 27 Aug 2033 and exclusivity 3 Nov 2030. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

N-(2,4-ditert-butyl-5-hydroxyphenyl)-4-oxo-1H-quinoline-3-carboxamide

Canonical SMILES

CC(C)(C)C1=CC(=C(C=C1NC(=O)C2=CNC3=CC=CC=C3C2=O)O)C(C)(C)C

InChIKey

PURKAOJPTOLRMP-UHFFFAOYSA-N