Drugs are given both trade names chosen by their manufacturers and nonproprietary names through standardized naming systems. Trade names are proprietary while nonproprietary names like International Nonproprietary Names (INNs) designated by the WHO are in the public domain. Selection of INNs follows principles of being distinctive, not too long, and not liable to confusion to ensure safe use of medicines globally.

3. QR Code for Attendance

4. Topic Title (1) Drug Nomenclature
Learning outcomes
1. Differentiate trade names and nonproprietary names
2. Explain drug nomenclature
3. Explain the use and protection of nonproprietary
names

5. Drug nomenclature
• Drugs are nothing but chemical substances
• There is a standard nomenclature system for
chemicals adopted by IUPAC
• However these are less suited to common
usage, being typically very long and unwieldy.
N-(4-hydroxyphenyl)acetamide

6. Drug names

7. Drug Nomenclature
• Not all chemicals synthesized in medicinal chemistry make
it to the markets as drugs
• Thus all are not named and instead labeled with a
alphanumeric code
• Here the alphabets denote the research group and the
numeric denote the compound i.e. Ro-Roche, ABT-Abbott
and MK- Merck
Ro31-8959 MK-639
ABT-538

8. National Nomenclature Systems
• United Kingdom (UK) established the system of British Approved Names
(BANs) in 1948 to provide convenient generic names
• Following this step, other countries including the USA, France, Italy and Japan
developed similar systems.
• BAN is the official nonproprietary name or generic name given to a
pharmaceutical substance, as defined in the British Pharmacopoeia.
• BAN is also used as the official name of pharmaceutical substances in many
other countries throughout the world, especially in countries belonging to
the British Commonwealth.
• BANs are approved on the basis of applications made by the inventor or
manufacturer of the pharmaceutical substance.
• The American system of nomenclature is called the United States Adopted
Names (USAN). This system is administered by the USAN Council.
• Three entities, the American Medical Association (AMA), the United States
Pharmacopeial Convention (USPC) and the American Pharmacists Association
(APA) sponsor the USAN Council.

9. International Non-proprietary Names
• The compounds shown in previous slides showed
promise as anti-HIV drugs and were named
saquinavir, ritonavir and indinavir respectively
• These names are selected by WHO and are
known as International Non-proprietary Names
(INN)
• The World Health Organization collaborates
closely with INN experts and national
nomenclature committees to select a single name
of worldwide acceptability for each active
substance that is to be marketed as a
pharmaceutical.

10. International non-proprietary names
• Initiated in 1950 by a World Health Assembly
resolution
• Began operating in 1953
• Cumulative list of INN now stands at some
7000 names designated since that time
• 120-150 new INN every year.

11. • The purpose of the INN system
is to identify pharmaceutical
substances or active
pharmaceutical ingredients.
• The system aims to provide a
unique and universally available
designated name to identify
each pharmaceutical substance.
• Clear identification on the basis
of INN helps in ensuring safe
prescription and dispensing of
medicines to patients.
• Since INNs are unique names,
they should be distinctive and
not liable to confusion with
other names in common use.
Need of INN system and its Features

12. INN
• Word “nonproprietary” suggests, WHO has formally
placed these names in the public domain. Hence, an
INN is open to being used by all manufacturers of the
pharmaceutical substance to which it relates.
• While such names can also be used for commercial
purposes, no private proprietary interest may be
acquired over these names.
• In other words, nobody can claim exclusive rights to
an INN or any part thereof through intellectual
property protection.

13. Selection of INN
• Initiated through an application proposing an INN for a new pharmaceutical
substance by its manufacturer or inventor.
• Three possible names to be recommended as an INN.
• Proposals to be submitted by the Director-General of WHO to the INN Expert
Group.
• Experts from the WHO Expert Advisory Panel on the International
Pharmacopoeia and Pharmaceutical Preparations then review the
application.
The selection process has the following stages:
1. First, an application for an INN is submitted by the manufacturer or
inventor of a pharmaceutical substance to the WHO INN Program;
2. Second, a review of the application is followed by the selection of a
proposed INN and its publication (in WHO Drug Information) for comments
(for a period of 4 months) by WHO INN Expert Group;
3. After a period of time allowed for opposing the proposed INN, the name
obtains the status of recommended INN and is published as such.

14. Selection of INN

15. Selection of INN
• INN is designated for the active part of the molecule
only, to avoid the multiplication of entries in cases
where several salts, esters, etc. are actually used. In
such cases, the user of the INN has to create a
modified INN (INNM).
– Ex: mepyramine maleate (a salt of mepyramine with maleic
acid)
• The primary principles for selection:
Distinctive in sound and spelling;
Not too long; and
Not liable to confusion with other names in
common use.
Ex: ac: anti-inflammatory agents, ibufenac
derivatives
-coxib for COX-2 inhibitors, a type of anti-
inflammatory
drugs (e.g. celecoxib)
Ranitidine Hydrochloride
Mepyramine maleate

16. Selection of INN
• Do not select names for mixtures of substances.
• Do not select for herbal substances (vegetable drugs)
or for homoeopathic products.
• Do not select names for those substances that have a
long history of use for medical purposes under well-
established names such as those of alkaloids (e.g.
morphine, codeine), or trivial chemical names (e.g.
acetic acid).

17. Selection of INN
• In the process of INN selection, the rights of existing
trade-mark owners are fully protected.
• If in the period of four months following the
publication of a proposed INN, a formal objection is
filed by an interested person who considers that the
proposed INN is in conflict with an existing trade-
mark, WHO will actively pursue an arrangement to
obtain a withdrawal of such an objection or will
reconsider the proposed name.
• As long as the objection exists, WHO will not publish
it as a recommended INN.

18. Protection of INN
• The World Health Organization collaborates closely with INN
experts and national nomenclature committees to select a
single name of worldwide acceptability for each active
substance that is to be marketed as a pharmaceutical.
• To avoid confusion, which could jeopardize the safety of
patients, trade-marks should neither be derived from INNs
nor contain common stems used in INNs.
• During the past few years, INN common stems have been
increasingly introduced in trademarks. This hampers the
selection of new nonproprietary names within the established
system. Given the fact that all INNs should be distinct from
existing INNs and trademarks, this practice causes difficulties
when selecting a new name.

19. Protection of INN
• Based on recommendations made by the WHO Expert
Committee on the Use of Essential Drugs, a resolution was
adopted during the 46th World Health Assembly requesting
Member States to:
– "Enact rules or regulations, as necessary, to ensure that
international nonproprietary name are always displayed
prominently;
– Encourage manufacturers to rely on their corporate name
and the international nonproprietary names, rather than
trademarks, to promote and market multisource products
introduced after patent expiration;
– Develop policy guidelines on the use and protection of
international nonproprietary names, and to discourage the
use of names derived from INNs, and particularly names
including INN stems in trademarks."

20. Trade names
• Once a drug proves successful then it is marketed as
a medicine by a company using a proprietary or trade
name
• This trade name can be used only by the company
which markets the medicine
• Saquinavir: Fortovase® (Roche), Ritonavir (Abbott):
Norvir®, Indinavir: Crixivan® (Merck)

21. Trade Names

22. • Trade names are specific to the preparation or
formulation of the drug rather than the active
constituent
• Fortovase® (Roche): Saquinavir 200 mg in gel filled beige
colored capsules , Invirase® (Roche): brown/green capsule
containing 200 mg of saquinavir as mesilate salt
• When the patent for drug expires then other
companies can produce and market the drug as
generic drug however they cannot use the trade
name used by the company that invented it
Trade names

23. Summary
• Most products available on the market are nowadays
advertised, promoted, and identified by a trade name.
• In pharmaceutical field, trade names are used when
prescribing, dispensing, selling, promoting, or buying a
medicament.
• Trade names are usually selected by the owner of the product
and registered in national trademark or patent offices. They are
private property and can be used only with the consent of the
owner of the trademark.
• In most cases brand names are chosen for a finished
pharmaceutical product. Therefore, pharmaceutical
preparations containing the same active drug substance are
frequently sold under different brand/trade names, not only in
different countries, but even within the same country.
contd..

24. Summary
• Various trade names for one substance (example: paracetamol)
• Nonproprietary names are intended to be used as public
property without restraint. These names are usually designated
by national or international nomenclature commissions.
• Nonproprietary names are designations to identify the active
pharmaceutical drug substance rather than the final product.
• The selection of a nonproprietary name follows established
rules so that the name itself communicates to the medical and
pharmaceutical health professional to which class the active
drug substance belongs.