In the dynamics of the healthcare and pharmaceutical industry and the challenges they are faced with, the importance of professional guidance in the name and brand development process and the regulatory approval is significant. So be sure to make the best possible start as you enter the market.
As partner in the GNN Global Naming Network, Readge shares projects, know-how and experience with first-class naming creatives, linguists, regulatory experts, intellectual property lawyers, and research companies all over the world.
The first step in naming a drug is selecting its generic or non-proprietary name. A non-proprietary name, also known as a generic name, is the official, standardized name given to a drug that identifies its active ingredient. It is not owned by any company and is used globally to ensure consistency and avoid confusion between different brands or versions of the same medication. For example, although OTC, "ibuprofen" is the non-proprietary name for the active ingredient found in many pain-relief products. One of the many 'Ibuprofen' brand names on the market is Advil​​​​​
​​​​​Two organizations must approve the names of generic drugs: the United States Adopted Names (USAN) Council and the World Health Organization (WHO) INN Programme. This ensures that patients and healthcare professionals can safely communicate about medications, regardless of location.
Generic names follow a formula. The suffix, or "family name," provides important information about how the drug works in the body. For example, Viagra’s generic name is sildenafil. The suffix “afil” indicates its role as a PDE 5 inhibitor, which helps control blood flow. Other erectile dysfunction drugs, such as tadalafil (Cialis), vardenafil (Levitra), and avanafil (Stendra), also use the “afil” suffix.
The prefix is more creative, chosen to be distinct from other generic names and easy to pronounce.
There are several rules when creating these names:
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The prefix must have two syllables to differentiate the drug and provide variety.
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Certain letters (Y, H, K, J, and W) are avoided since they are not used in some languages with the Roman alphabet.
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The name cannot include the company’s name or any promotional terms (like "best" or "strongest").
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It must avoid medical terms that could limit the drug's use to a specific purpose, allowing for future broader applications.
Once 3 to 6 potential names are selected, they are submitted to the WHO. If accepted, the name is forwarded to USAN for review. If USAN approves it, the name is published on the proposed International Nonproprietary Names (INN) list. Over the next four months, the public can object. If no objections are raised, the name is added to the recommended INN list, and the drug can be referred to by its nonproprietary name instead of its code.
​​Unlike generic names, a brand name isn't tied to particular suffixes, which allows for more creativity.
The name is meant to be representative of the drug in some way, ranging from abstract ideas, tonality, strong sound or gentle sound. It can be imagery. You hear a word and it brings something positive to mind, or a nice association that isn’t a claim. Several rules apply to developing the brand name for medications. For starters, the name can’t make an overt claim about what it does, nor can it be promotional. It should avoid any use of generic name stems and everything should be done to avoid confusion.
The process roughly works like this
Readge's Pharmanaming team begins with establishing the brand's positioning, writes a brand story, determines the framework conditions with the client's regulatory department and a place and relation in the product portfolio, sets the schedule, who is involved, what submission procedure will be followed (FDA, EMA, DCP or CP), involves the different countries if necessary and investigates possible creative routes. When all that is done and there is a good picture of the goal we want to get to, potential lists of hundreds of names are created, and based on all kinds of checks and searches these lists will need to be dramatically reduced. In the end, The Food and Drug Administration (FDA) will review only one proposed name at a time, and the European Medicines Agency (EMA) will review only two.
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The narrowing-down process begins with several checks and surveys for further elimination, that include:
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Trademark screening and clearance in the relevant classes (mostly 5 and 10). A team of attorneys scrutinizes each name to make sure that name is truly unique. All companies developing drug brands have to be diligent that it’s not getting too close to other company's brand names, or generic names.
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Checks in the INN (International Non-proprietary Names) published registers by the World Health Organisation
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Pharma in Use checks in the Worldwide Intellectual Property Organisation's register (WIPO)
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Domain name and social media availability checks, for defensive reasons. Far from all brands are registered, while there are names used online with which you do not want to be associated
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Linguistic checks. Does the drug name translate ok? The goal is to have a product that is appealing on a global scale, so it’s important to make sure it sounds and reads okay, regardless of the language or dialect. The brand name is checked in major world languages to make sure the name in its entirety does not mean or imply a word or phrase that would be inappropriate or embarrassing.
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Safety checks for interpretation during the prescription process. Safety is the major focus in naming drugs. If one medication name is confused with another, the mistake could have serious consequences. To avoid any confusion, make sure that the proposed names do not look or sound like another that when coupled with an analysis of similar prescribing characteristics (dose strength, frequency, route of administration, etc.) could produce a medication dispensing error. A prescription simulation interpretation tests with verbal orders, computer entry orders, and handwriting to see if the name could be confused with another when written in a doctor’s potentially messy script.
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Perception checks among health care professionals, to gauge how they respond to the different names, inquiring about areas such as safety as well as general likeability of the way the word looks, sounds and how memorable it is.
​The final steps: submission and approval
All of those steps shorten the list to a final handful of just around three names. The project team then selects the favorite name to submit to the FDA and their favorite two names to submit to EMA. At long last, they wait to find out if the name is approved. While two to three years seems like a long time for a drug brand name to be developed, screened and ultimately accepted, it’s an important process that no other industry has and is designed with the patient in mind.
But those steps are absolutely needed to ensure that every medication name is as distinct as it can be.