Naming of New Drugs l International Non-proprietary Name [INN] or Generic Name

                                                

Naming of New Drugs

During the R&D process, a new pharmaceutical substance is given an International Non-proprietary Name [INN] or generic name, in addition to the name that may eventually become its proprietary, or brand, name. Each INN is unique, globally recognised and is public property.

Non-proprietary names are intended for use in pharmacopoeias, labelling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names, e.g. for generics. Their use is normally required by national or, as in the case of the EU, by international legislation. As a result of ongoing collaboration, national names such as British Approved Names (BAN), Dénominations Communes Françaises (DCF), Japanese Adopted Names (JAN) and United States Accepted Names (USAN) are nowadays, with rare exceptions, identical to the INN. Names which are given the status of an INN are selected by the World Health Organisation on the advice of experts from the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations.

 An important feature of the INN naming system is the use of a common “stem” which indicates the activity of the substance and the pharmacological group to which it belongs. The stem is generally placed at the end of the name, but in some cases it may be placed at the beginning or in the middle of the name. For example: substances having

·       adol/-adol- as the stem indicates an analgesic (e.g. tramadol);

·       mab indicates a monoclonal antibody (e.g. infliximab);

·       azepam indicates a diazepam derivative (e.g. temazepam) and

·       vir indicates antiviral agents (e.g. acyclovir).

All of the stems recommended by the WHO are contained in the “stem book” along with guidance for their use . The INN, containing the common stem, provides a single, unique name which enables healthcare professionals to recognise the substance and the family of similar pharmacological substances to which it belongs. The INN is generally the name under which the generic from of a drug is marketed.