Tolvaptan

Overview

Tolvaptan is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL344159).

API suppliers (13)

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

• AURORE LIFE SCIENCES PRIVATE LTD1 active DMF GMP on record
• Hetero Drugs LimitedIndia1 active DMF GMP on record
• Zhejiang Huahai Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• Apotex Pharmachem India Pvt. Ltd.India1 active DMF
• Lupin LimitedIndia1 active DMF GMP on record
• Alkem Laboratories LimitedIndia1 active DMF GMP on record
• OLON SPAItaly1 active DMF GMP on record
• EXTROVIS AGSwitzerland1 active DMF
• Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
• AMI LIFESCIENCES PRIVATE LTDIndia1 active DMF GMP on record
• Zydus Lifesciences LimitedIndia1 active DMF GMP on record
• SRI KRISHNA PHARMACEUTICALS LTDIndia1 active DMF GMP on record
• JIANGSU HENGRUI PHARMACEUTICALS CO LTDChina GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (33 approved US products), the latest listed US patent on Tolvaptan expires 7 Apr 2030. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

N-[4-(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1-benzazepine-1-carbonyl)-3-methylphenyl]-2-methylbenzamide

Canonical SMILES

CC1=CC=CC=C1C(=O)NC2=CC(=C(C=C2)C(=O)N3CCCC(C4=C3C=CC(=C4)Cl)O)C

InChIKey

GYHCTFXIZSNGJT-UHFFFAOYSA-N