for the healthcare and pharmaceutical industry
The U.S. Food and Drug Administration
The Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) in Europe must approve pharmaceutical compounds and biologics prior to public consumption. The brand names for these drugs must also be authorized and approved.
The primary function of the FDA naming process is to minimize or eliminate the risk of medication errors that result from the branding or naming of a pharmaceutical product. Its secondary function is to make sure that approved names don’t communicate anything false or misleading to consumers who may be taking the drug. This is from both a safety perspective, as well as an expectation perspective on the part of the patient.
Maximizing a successful outcome
The most significant steps to take involve testing and examining the name before applying for trademark protection or submitting the name to the FDA or any global regulatory authority. One way to legally minimise the risk of rejection and accelerate the success of the process is to understand how the FDA evaluates names and what factors they consider. Look at the drug candidate and the FDA process and be aware of the other products and drug treatments available, understand the generic nature of the ingredients that are part of the actives as well as the excipients, and make a first level cut at what should move forward in the process.
The next step is to test the name candidates for similarity to other brand names on the market and consider the proposed names from the oral or spoken perspective. Is it going to sound too much like something else when called out by a medical professional, patient or even pharmacist? Always consider whether a doctor’s written prescription is going to look too similar to something else. Studies have shown that when a physician writes a prescription the first couple letters of the drug name are clearer than the last couple.
So, if you have two drugs that begin with the same letter string, there may be an increased likelihood for confusion at the point of dispensing, and an increased risk of a medical mistake.
It is important to test candidate names through interviews, focus groups or online testing to end-users and professionals.
If the new drug is expected to be a blockbuster, be sure to invest in testing the name with relevant constituencies before you even walk through the door at the FDA. This may help speed up the FDA approval and will help to avoid potential rebranding situations later on in the process.
We usually recommend to register a number of names and then decide which 2 or 3 will be moved forward in the FDA process, to avoid that the FDA has approved your name only to learn that someone else was is already using the same name or a confusingly similar one for pharmaceuticals or in a related area that doesn’t require regulatory approval.
Over The Counter drugs
For OTC drugs there are more issues to contend with because the risk of consumer confusion is greater as a result of the way that OTC drugs are presented through advertising, packaging, and point of sale merchandising. There are a number of things that are done to distinguish one brand from the next, including the core branding elements, which include the name itself and package presentation in terms of size, colour and layout.
Drugs always have three names, the chemical name, the nonproprietary name or INN that every company can use, and the proprietary name owned by one company.
Nurofen for instance is the brand name for isobutylphenylpropanoic acid, a non-steroidal anti-inflammatory drug (NSAID) used for relieving pain, helping with fever and reducing inflammation, called by its nickname ibuprofen and owned by Reckitt Benckiser.
The INN Ibuprofen is sold under many other proprietary or brand names by different companies, of which the brands Advil, Anadin, Brufen and Motrin are the most well known.
Other proprietary names of ibuprofen in the market are: Actron, Adex, Arinac, Advifen, Aktren, Alaxan, Alges-X, Algifor, Algoflex, Algofren, Alindrin, Alivium, Arthrofen, Artofen, Betagesic, Betaprofen, Bonifen, Bugesic, Buplex, Burana, Buprofil, Caldolor, Calprofen, Combiflam, Dalsy, Dismenol, Diverin, Dolgit, Dolofort, Doloraz, Dolormin, Dolo-Spedifen, Dorival, Easofen, Ebufac, EmuProfen, Espidifen, Eve, Fenbid, Fenpaed, Finalflex, Galprofen, Ibu, Ibugel, Ibugesic, IbuHexal, Ibuleve, Ibum, Ibumax, Ibumetin, Ibumidol, Ibupain, Ibuprofene, Ibuprom, Ibuprox, Ibuprosyn, Nuprin and many others.