News feature: Where do generic and brand names come from?
Where do generic and brand names come from?
In the course of their work, pharmacists handle hundreds of drugs every day. Many have names that seem like old friends, while others seem to have come from another planet. Yet, how many pharmacists stop to consider how drugs get their names? Frances Thompson discovers how
Until the 1939?45 war, most drugs were either natural products or extracts of natural products. However, by the late 1940s, synthetic drugs were beginning to become more common. The system of British Approved Names (BAN) was set up in 1948 to provide convenient generic names by which people could refer to these increasingly complicated compounds the chemical names were becoming too lengthy and incomprehensible for general use.
At about the same time, other countries also began introducing naming systems. However, there was little or no communication between countries about drug names, and instances began to arise of the same drug being called by different names in different countries (eg, acetaminophen being used in the United States to describe paracetamol). To co-ordinate the naming of drugs, the World Health Organization set up International Nonproprietary Names (INNs) in 1951. Since then, drug naming has been consistent throughout the world.
Roger Trigg, secretary of the British Pharmacopoeia Commissions nomenclature committee, summarises the system for obtaining an INN: Once a name has been chosen by a manufacturer, it is reviewed by the BAN committee secretariat (or its equivalent in other countries) for its suitability. If it is considered acceptable, an application is made to the WHO for it to become a proposed INN. These days, no name is likely to be totally free of conflict in every country, so once the INN committee has agreed the name, it publishes a list of proposed INNs in several languages. Objections to any of the proposed INNs can be made by countries or by companies and must be lodged within four months of publication of this list. Once this period is over and there has been a final review, the list is finalised and the name becomes a recommended INN. The process takes 15 months, on average.
If an objection is successfully brought against an INN, then the name remains a proposed INN and never becomes recommended. It is easier to accept that that name will be used throughout the world except in the objecting country than to start the whole process again (eg, in the UK, ribavirin was objected to on the grounds that there was already a trade mark Rybarvin. Tribavirin was used until Rybarvin was discontinued). About 60 per cent of the recommended INNs that have been assigned are in current use for marketed products; the rest have fallen by the wayside.
Choosing a generic name
Mr Trigg says that it is becoming harder to name drugs. Nomenclature moved away from names made up from distinctive syllables taken from the drugs chemical structure (eg, chlorpromazine) many years ago. Now, a system is used that combines a stem that reflects the pharmacological action of the drug with a distinctive prefix The more abstract the prefix, the better, he remarks.
Very occasionally we get it wrong and create a name that is too similar to an existing name. Computerised databases have made this less likely but the problem is there is a finite number of letters and names available. It is a major undertaking to change the INN of a drug once it has been assigned it costs manufacturers a great deal of money and creates a lot of work for them. If we find that two drugs do have similar names, we only change them if the risk to patients is too great. If the formulations and indications are completely different (say, if one is a cream and one is an injection) then it is unlikely to be a problem, so we would not change the names. Similarly, no change would be made if one product is a prescription-only medicine and the other is only available over the counter, he adds.
In 1999, EC Directive 92/27, which requires medicines to be labelled with the recommended INN throughout the EU, took effect. The majority of recommended INNs are the same as the BAN. In most of the others, the only difference from the BAN is the spelling. However, a few are completely different (the recommended INN for benzhexol is trihexyphenidyl).
Adrenaline presents a particular difficulty. The recommended INN is epinephrine but throughout the whole of Europe and most other parts of the world (the US and Japan are two exceptions), adrenaline is the familiar name. Member states of the Council of Europe have expressed their desire to keep adrenaline as the basis of European Pharmacopeia monograph titles. In addition, most health professionals that have been consulted have said that the name adrenaline should be retained. A system of dual labelling was introduced to overcome this difficulty and to accommodate a small number of other names, where patient safety was believed to be jeopardised by changing to the INN. The Department of Health is currently grappling with the legal implications of this unsatisfactory situation, Mr Trigg says.
So, what criteria are used when choosing a generic name for a drug? Any new name should be different from an existing name. It should reflect the drugs similarity to existing similar substances, where appropriate, in that it should include the stem common to the group (usually a suffix). For example, if it is an HMG CoA inhibitor, the name should end in -vastatin, Mr Trigg explains.
Mr Trigg highlights difficulties that can occur when naming drugs: The criterion that states that drugs with similar pharmacology or use should have a common stem, becomes difficult when a drug has more than one pharmacological action. In addition, a drug could be named with one use in mind but, if a new property of the molecule is discovered, it might end up being given for a completely different indication.
He adds that, sometimes, drugs are named before their therapeutic use is really known. It is always a dilemma knowing when to create a new group stem. Manufacturers are keen for their drug to have a new stem, so that it appears to be a different pharmacological subtype from anything already available. Yet, how different should a drug be before it deserves a new stem and isnt just classed as a me-too? In the early stages of development, it can be difficult to know how different a drugs actions are from those of other drugs, Mr Trigg says. In such cases, the drug is given a name with a distinctive second half that can be used as a stem in future if it becomes obvious that the drug really is of a new pharmacological subtype.
Prodrugs, which are generally esters of the original molecule, can be named in two ways either by adding a prefix to the original drugs name (eg, pivampicillin) or by making it a two-word name (eg, cefuroxime axetil). I prefer a single-word name, because it is possible that the second word could be left off a prescription. However, not everyone shares that view. Theres been no consistency over the years in this case, Mr Trigg says.
Names for combination products are contentious (eg, co-fluampicil for products containing equal parts of flucloxacillin and ampicillin). Not everybody likes the co names that we give to combination products but I dont think there is a better way to do it, Mr Trigg says. If you put the co at the end of the name, it gets left off. Also, if we dont use these names first, companies do Co-Betaloc, for example and then we end up having to use something clumsy.
Also putting the co at the end of a name makes it much more likely that the name will infringe somebodys trademark. For example, if frusamil-co had been used as the generic name for furosemide/amiloride hydrochloride combination products, it would have been in more serious conflict with the brand name Frumil than co-amilofruse. Having co at the front of a name immediately tells a prescriber that this is a combination product. Nevertheless, we will be cautious about any more that we issue in the future.
The Royal Pharmaceutical Society has a different view of co names, as Tony Moffatt, the chief scientist, explains: The Society doesnt like co names. The view is that such names can be so similar that they lead to confusion when prescribing or dispensing, and a patient could end up with the wrong medicine.
Establishing a brand name
As well as obtaining generic names for their products, companies will generally want to give them brand or proprietary names. This is an entirely separate process, which can differ between companies.
Lesley Edwards, until recently the head of the trademarks department at Glaxo Wellcome and who is now an independent trademark consultant, explains: The process normally starts when a product reaches phase II trials, although this can vary it might start much earlier for drugs that are likely to be fast-tracked through the system. Choosing and registering a brand name is a long and expensive process, so it is important to get the timing of naming right, to avoid wasting time and money many fall by the wayside before reaching the market.
Often, a name creation agency is used as a source of ideas for names but, sometimes, they arise as a result of a brainstorming session within a companys marketing department. The marketing department develops a branding strategy for each product, which includes the name that it might be given. Ms Edwards says: Names are chosen using many criteria. Ideally, the name should be memorable, pronounceable and different. Often, it will reflect the mode of action, or the therapeutic area or part of the body that the medicine will be used in. A great example of a product that tells you exactly what it is for would be Hedex, although proprietary names should not be overtly descriptive, otherwise they cannot be protected by trademark registration.
Tom Blackett, deputy chairman of Interbrand Group, a name creation agency, agrees that a products name is decided on the basis of the branding strategy and adds that the place in the market that a company wants the medicine to have is also important.
The name has to reflect the branding strategy. For example, we developed the name Zofran (ondansetron). The branding strategy for this product was to create a soft and reassuring image, because the medicine is intended to help patients to tolerate chemotherapy. For this reason, we chose a brand name with a soft sound compare the sound of Zofran with Zantac, which sounds much more aggressive.
Ms Edwards remarks: As with anything else, there are fashions in naming at one time, there were lots of Xs and Zs. Companies should try to avoid INN stems and names that can be linked too closely with the generic name. If the generic and proprietary names are too similar, it becomes too easy to prescribe the drug generically.
Mr Blackett describes one of the first steps in the process of choosing a brand name: When we have been briefed by a company to come up with a brand name for a product, we hold a brainstorming session that involves people who are good at words, and we present them with the strategy. They will then come up with an initial list of possible names. The more unusual these are, the more likely it is that they will not already have been used brand name registers world-wide are so crowded these days. This is why there have been a lot of names beginning with Z recently. At an early stage, we will also use consultants who are specialists in the relevant field of medicine, to find out their perceptions of products already on the market and what image they have of them.
The agency presents the inital list (about 50 names) to the company in groups of images some might represent a strong image, some a reassuring image or they might be completely abstract. This list is whittled down to about 30 names, for which the agency does a simple trademark search and a screen for their suitability in different languages. Companies like to use the same brand in all markets, so it is important to check that names do not mean something vulgar or unpleasant in a foreign language, Mr Blackett explains.
About 15 names are selected from the 30 and the pharmaceutical companys trademark department then searches databases in major countries for similar or identical trademarks that are already registered. The marketing department then prioritises the remaining names and a similar but much more extensive search is done. This process can take months but it is vital, if a company is to be certain of getting a global trademark that has not already been registered, Ms Edwards says.
Ideally, three or four names for any product are submitted for registration as trademarks in major countries, in case there are any last-minute, unexpected objections. However, the centralised procedure for the registration of pharmaceuticals in the EU has made this virtually impossible in practice, because it is difficult to find trademarks that are available throughout the whole of the EU. This can narrow down the list considerably. It would be a disaster if a launch couldnt go ahead because the product didnt have a name, says Ms Edwards.
Mr Blackett says: Doctors like to think they are not influenced by branding but they are. Why else would they still be writing prescriptions for Ventolin when a generic has been on the market for years?
Citation: The Pharmaceutical Journal URI: 20004826
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