Varenicline
Overview
Varenicline is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1076903).
API suppliers (4)
Suppliers of Varenicline evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
2 of 4 hold a GMP certificate on record in the EU or UK registers
- TAPI NL BVNetherlands1 active DMF
- MEDICHEM SASpain1 active DMF GMP on record
- ACTAVIS GROUP PTC EHFIceland1 active DMF GMP on record
- Viwit Pharmaceutical Co., Ltd.China1 active DMF
Patent & exclusivity (US)
Per the FDA Orange Book (44 approved US products), the latest listed US patent on Varenicline expires 19 Oct 2035. Generic API sourcing typically opens up once these lapse.
Chemical identity
- IUPAC name
- (1S,12R)-5,8,14-triazatetracyclo[10.3.1.02,11.04,9]hexadeca-2,4,6,8,10-pentaene
- Canonical SMILES
- C1[C@@H]2CNC[C@H]1C3=CC4=NC=CN=C4C=C23
- InChIKey
- JQSHBVHOMNKWFT-DTORHVGOSA-N
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