Naming of pharmaceutical products
Who and how invents the name of a medicine
The process begins well before the drug is registered — sometimes even at the stage of clinical trials. The company prepares a brief with a description of the active substance, target audience, and therapeutic group, and then a team is assembled, where each specialist is responsible for their own risk area.
- Marketers and brand strategists — responsible for memorability, pronounceability, associations with health and the drug's effect;
- Linguists — check the sound of the name in different languages, exclude undesirable associations in the cultures of target markets;
- Pharmacologists — ensure that the name does not hint at non-existent properties and does not overlap with similar substances in action;
- Intellectual property lawyers — check patent cleanliness and the possibility of trademark registration;
- Regulatory specialists — prepare the name for review at the FDA, EMA, or the Ministry of Health of the Russian Federation.
From 200–300 initial options, only 3–5 names usually reach the final review, and regulators often reject even these — due to phonetic similarity with already existing drugs.
The official and trade name: different logic, different approaches
The International Nonproprietary Names (INN) system was established by the World Health Organization (WHO) resolution WHA3.11 in 1950 and began to function practically in 1953 — and since then more than 8000 names have been published. The purpose of INN is not to be memorable to the patient, but to honestly inform the specialist about which pharmacological group the substance belongs to. For this, structural elements — stems are used: the suffix «-olol» indicates beta-blockers, «-pril» — ACE inhibitors, «-statin» — cholesterol-lowering drugs. The rules of INN are set out in the WHO Stem Book and require avoiding the letters h and k — they are pronounced differently in different languages and create a risk of error.
Linguistic techniques in INN are strictly functional: blending of roots (amoxicillin — from amino- and penicilline-based roots), truncation of long chemical terms, standardized suffixation. Here, creativity is minimal — the task is not to stand out, but to be classified.
Trade names work on the reverse logic. Here, the same suffixation and truncation serve not for classification, but for memorability and a «telling» effect: metathesis (sound permutation) and blending are applied so that the name sounds easy and is associated with recovery, not a chemical formula. According to Order No. 429n of the Ministry of Health of the Russian Federation dated 29.06.2016, a trade name must be «pleasant-sounding, brief, easy to pronounce, and familiar in sound to the Russian language» — that is, an aesthetic requirement, not only a terminological one.
Why similar names kill people: the case of Celebrex and Cerebyx
A classic example of confusion is the anti-inflammatory drug Celebrex and the anticonvulsant Cerebyx. The names differ by only a couple of letters, but they belong to different therapeutic groups with different dosages. Cases have been documented in U.S. pharmacy practice where one drug was dispensed instead of another — putting patients at risk, such as when an anticonvulsant was given instead of an analgesic, or vice versa.
This and dozens of similar cases explain the ISMP (Institute for Safe Medication Practices) statistics: 15–25%, and according to some estimates, even more, medical errors are directly related to the similarity of names, and additionally 33% — to similar packaging design. The problem is not in doctors' inattention, but in a systemic design error in the name that could have been prevented at the registration stage.
How names are checked for safety
Following cases like Celebrex/Cerebyx, regulators formalized the methodology for checking graphical and phonetic similarity. The basic rule is that the minimum difference between names must be 3 or more letters or signs in any combination. The check is performed in several directions:
- Phonetic analysis — how the name sounds when pronounced quickly, including with accent or over the phone;
- Graphic analysis — how the name looks when handwritten in a prescription, where letters can easily be confused;
- Checking against existing trademarks in the database of similar drugs in the same and related therapeutic groups;
- Dosage perception test — whether the name creates a false impression of the drug's strength or weakness.
Technology has significantly reduced the risk: after the introduction of electronic prescription-writing systems in the USA, the proportion of errors related to illegible handwriting and similar-sounding names dropped from 42,5% to 6,6% according to studies from 2008–2009 years. This shows that the naming problem is not only solved at the stage of creating the name, but also at the stage of its use in medical practice.
Regulatory requirements: one problem, different approaches by country
Each major jurisdiction has developed its own system of trademark examination, although the goal is the same — to minimize the risk of confusion and unfair advertising.
| Regulator / Document | Region | Feature of the Approach |
|---|---|---|
| WHO Stem Book | International | Regulates only the International Nonproprietary Name (INN) and defines structural elements (stems) for the classification of substances |
| Order of the Ministry of Health of the Russian Federation №429n | Russia | Requires euphony, brevity, and familiarity of sound for the Russian language when registering a trade name |
| FDA (POCA — Proprietary Name Review) | USA | Double examination: risk of medical error and risk of exaggerated advertising promises in the name |
| EMA | European Union | Checking for similarity across all 27+ countries simultaneously, taking into account different languages and alphabets |
That is where the difference in timelines comes from: in the EU, trademark examination takes longer precisely due to the need to test phonetic similarity across dozens of languages, whereas in Russia the focus is on compliance with Russian language norms and absence of overlap with already registered drugs in the country.
Original and generic: why one substance has dozens of names
A patent on an original drug usually lasts 20 years. During that time, the manufacturer is protected by a monopoly and invests in the recognizability of the trade name — it is this name, not the INN, that becomes a brand with a billion-dollar capitalization. After the patent expires, other companies produce generics with the same active ingredient and the same INN, but each registers its own trade name. Thus, the same ibuprofen on a pharmacy shelf exists under dozens of names — and the task of naming here is not to invent a unique meaningful molecule, but to fit into the existing niche without the risk of a legal conflict with the original brand and without confusion with competitor generics.
Who and how invents the name of a medicine
The process begins well before the drug is registered — sometimes even at the stage of clinical trials. The company prepares a brief with a description of the active substance, target audience, and therapeutic group, and then a team is assembled, where each specialist is responsible for their own risk area.
- Marketers and brand strategists — responsible for memorability, pronounceability, associations with health and the drug's effect;
- Linguists — check the sound of the name in different languages, exclude undesirable associations in the cultures of target markets;
- Pharmacologists — ensure that the name does not hint at non-existent properties and does not overlap with similar substances in action;
- Intellectual property lawyers — check patent cleanliness and the possibility of trademark registration;
- Regulatory specialists — prepare the name for review at the FDA, EMA, or the Ministry of Health of the Russian Federation.
From 200–300 initial options, only 3–5 names usually reach the final review, and regulators often reject even these — due to phonetic similarity with already existing drugs.
The official and trade name: different logic, different approaches
The International Nonproprietary Names (INN) system was established by the World Health Organization (WHO) resolution WHA3.11 in 1950 and began to function practically in 1953 — and since then more than 8000 names have been published. The purpose of INN is not to be memorable to the patient, but to honestly inform the specialist about which pharmacological group the substance belongs to. For this, structural elements — stems are used: the suffix «-olol» indicates beta-blockers, «-pril» — ACE inhibitors, «-statin» — cholesterol-lowering drugs. The rules of INN are set out in the WHO Stem Book and require avoiding the letters h and k — they are pronounced differently in different languages and create a risk of error.
Linguistic techniques in INN are strictly functional: blending of roots (amoxicillin — from amino- and penicilline-based roots), truncation of long chemical terms, standardized suffixation. Here, creativity is minimal — the task is not to stand out, but to be classified.
Trade names work on the reverse logic. Here, the same suffixation and truncation serve not for classification, but for memorability and a «telling» effect: metathesis (sound permutation) and blending are applied so that the name sounds easy and is associated with recovery, not a chemical formula. According to Order No. 429n of the Ministry of Health of the Russian Federation dated 29.06.2016, a trade name must be «pleasant-sounding, brief, easy to pronounce, and familiar in sound to the Russian language» — that is, an aesthetic requirement, not only a terminological one.
Why similar names kill people: the case of Celebrex and Cerebyx
A classic example of confusion is the anti-inflammatory drug Celebrex and the anticonvulsant Cerebyx. The names differ by only a couple of letters, but they belong to different therapeutic groups with different dosages. Cases have been documented in U.S. pharmacy practice where one drug was dispensed instead of another — putting patients at risk, such as when an anticonvulsant was given instead of an analgesic, or vice versa.
This and dozens of similar cases explain the ISMP (Institute for Safe Medication Practices) statistics: 15–25%, and according to some estimates, even more, medical errors are directly related to the similarity of names, and additionally 33% — to similar packaging design. The problem is not in doctors' inattention, but in a systemic design error in the name that could have been prevented at the registration stage.
How names are checked for safety
Following cases like Celebrex/Cerebyx, regulators formalized the methodology for checking graphical and phonetic similarity. The basic rule is that the minimum difference between names must be 3 or more letters or signs in any combination. The check is performed in several directions:
- Phonetic analysis — how the name sounds when pronounced quickly, including with accent or over the phone;
- Graphic analysis — how the name looks when handwritten in a prescription, where letters can easily be confused;
- Checking against existing trademarks in the database of similar drugs in the same and related therapeutic groups;
- Dosage perception test — whether the name creates a false impression of the drug's strength or weakness.
Technology has significantly reduced the risk: after the introduction of electronic prescription-writing systems in the USA, the proportion of errors related to illegible handwriting and similar-sounding names dropped from 42,5% to 6,6% according to studies from 2008–2009 years. This shows that the naming problem is not only solved at the stage of creating the name, but also at the stage of its use in medical practice.
Regulatory requirements: one problem, different approaches by country
Each major jurisdiction has developed its own system of trademark examination, although the goal is the same — to minimize the risk of confusion and unfair advertising.
| Regulator / Document | Region | Feature of the Approach |
|---|---|---|
| WHO Stem Book | International | Regulates only the International Nonproprietary Name (INN) and defines structural elements (stems) for the classification of substances |
| Order of the Ministry of Health of the Russian Federation №429n | Russia | Requires euphony, brevity, and familiarity of sound for the Russian language when registering a trade name |
| FDA (POCA — Proprietary Name Review) | USA | Double examination: risk of medical error and risk of exaggerated advertising promises in the name |
| EMA | European Union | Checking for similarity across all 27+ countries simultaneously, taking into account different languages and alphabets |
That is where the difference in timelines comes from: in the EU, trademark examination takes longer precisely due to the need to test phonetic similarity across dozens of languages, whereas in Russia the focus is on compliance with Russian language norms and absence of overlap with already registered drugs in the country.
Original and generic: why one substance has dozens of names
A patent on an original drug usually lasts 20 years. During that time, the manufacturer is protected by a monopoly and invests in the recognizability of the trade name — it is this name, not the INN, that becomes a brand with a billion-dollar capitalization. After the patent expires, other companies produce generics with the same active ingredient and the same INN, but each registers its own trade name. Thus, the same ibuprofen on a pharmacy shelf exists under dozens of names — and the task of naming here is not to invent a unique meaningful molecule, but to fit into the existing niche without the risk of a legal conflict with the original brand and without confusion with competitor generics.
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