Watch television for more than a few minutes, and it’s likely you will see a commercial for a prescription drug. And if you see an ad for Rinvoq® (upadacitinib), Dupixent® (dupilumab) or Skyrizi® (risankizumab) during that brief time, it isn’t too surprising, as their manufacturers were the top three spenders on TV ads in 2022.
Pharmaceutical companies spend billions of dollars each year on marketing as a part of their strategy to increase brand recognition and improve market share — and that success is built on a strong foundation established by the drug’s name. In this article, we explore how the pharmaceutical naming process relies on both science and creativity, not to mention the ability to survive a gauntlet of approvals.
What’s in a Name? Or Three?
You’ll often encounter two names for marketed medicines: the brand name, a catchy proper noun that is trademarked, and the generic (or chemical) name, which can appear in parenthesis after the brand name or on its own. We will touch on these two names in a moment, but before the generic name is determined or the brand name is developed, a reference name sees the medicine through the earliest phases of drug development.
A Drug’s First Name
When pharmaceutical research teams discover a novel compound that they want to explore as a potential medicine, they assign a reference name to track it through early discovery and, if the compound shows promise, through clinical trials. The reference name typically has initials that identify the manufacturer followed by their established numbering convention. For example, MK-5890 is a drug in Merck’s pipeline while PF-07923567 is a drug from Pfizer.
When a compound shows promise in early clinical trials, the process of giving it a generic name and a brand name begins — a process that can take up to four years.
Before the early 1960s, drugs didn’t have generic names and there was no way to readily determine if any two drugs had the same active ingredient. The United States Adopted Name (USAN) Council was created in 1963, growing out of a partnership between the American Medical Association, the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA).
The USAN was tasked with assigning standard generic (nonproprietary) names that convey the active ingredient for any regulated pharmaceutical approved for use in the US. These names were originally intended to help healthcare professionals distinguish medicines within the same class from one another, but anyone who either takes, or cares for someone who takes, multiple medicines can benefit from knowing what the different elements of the generic name signify.
To date, the USAN Council has assigned more than 13,000 nonproprietary drug names. A drug can’t be marketed in the US without a USAN, and the FDA recognizes the USAN as the legal name for an active drug ingredient.
Generic Drug Naming 101
Generic drug names use common prefixes, suffixes, and stems (or roots) to convey the clinical or chemical category or receptor selectivity of a medicine — ideally without being too long or difficult to pronounce.
Examples of prefixes include gli- which indicates an oral hypoglycemic control agent, while names that start with sulfa- indicate the drug is a sulfonamide, a synthetic antimicrobial drug, and those that start with nal- work on opioid receptors. There are times when the prefix has no specific meaning but helps differentiate within a crowded class of approved medicines.
The stem (also known as the root or suffix) conveys the medicine’s action or indication. For example, names ending in -cillin or -cycline are penicillin or tetracycline-based antibiotics, while -statin is a renal dehydropeptidase inhibitor pepsin inhibitor (aka cholesterol-lowering medicine). The suffix may also refer to the structure, such as -mab, which indicates the medicine is a monoclonal antibody
Ideally, a generic name is approved before researchers publish papers about the efficacy or safety of a new drug. A pharmaceutical company will submit three to six names to the USAN Council when a drug is in Phase 1 or 2 clinical trials. One of the names is either accepted or the USAN proposes an alternate name that the company can then opt to accept (or repeat the process as needed).
After a name is accepted, the USAN Council submits it to the World Health Organization (WHO) for their review and acceptance or counterproposal. Once a name is accepted by all parties, it is published for public comment. If no one objects, the generic name is officially established.
At this milestone, the sponsoring pharmaceutical company can drop the reference number and start using the generic name when publishing clinical trial data and engaging in early discussions about the medicine
Considerations in Choosing a Generic Name
During its review and approval process, the USAN Council crosschecks names using existing drug databases and using Phonetic and Orthographic Computer Analysis (POCA) software to avoid creating new names that begin and end with an existing generic or trade name for other drugs. It’s also on the lookout for how new drug names could potentially get confused with existing drug names in writing and speech — a potential risk to patient safety.
The Building of a Brand Name
Brand naming often starts later in drug development — during Phase 2 or 3 of clinical trials. Drug manufacturers often hire branding agencies for help. To start the process, agencies may brainstorm a thousand or more candidate names. Why so many? Because the list will get whittled down from there, especially as drug nomenclature gets harder and more established names (that new brands can bear no resemblance to) have been trademarked. Most will be eliminated as they’re checked against existing trademarks and subjected to regulatory review.
An effective, catchy brand name sets up the marketing for telling the story of a drug. Brand names may be influenced by the drug’s mechanism of action or a particular attribute, benefit, or effect. Sometimes, a part of a drug’s brand name will intentionally have a particular association. For example, Paxil®, used to treat diseases and disorders of the central nervous system, contains the root “pax”, which suggests peacefulness, and the name Viagra®, used to treat erectile dysfunction, suggests vigor and vitality — but these run the risk as being seen as a promise of efficacy that would need to be substantiated.
Key considerations for brand names include the following:
A brand name should not:
- Make an overt claim about what it does.
- Be promotional.
- Use generic name stems that could confuse healthcare professionals and patients.
- Infringe upon existing trademarks.
- Be or imply a word that could be offensive or embarrassing in a major language.
- Be too similar to other medications’ names and prescribing characteristics, to help prevent dispensing errors.
A brand name should:
- Sound OK to speakers of different languages and dialects.
- Pass verbal and handwriting checks, to prevent dispensing errors.
- Be perceived well by the public.
Many pharmaceutical companies adopt a “blank canvas strategy.” That means they try to come up with a name with a limited number of syllables that’s easy to remember and pronounce and that differentiates it from other drug names. In short, the chosen name doesn’t have to mean anything.
Brand names often endure past the expiration of the drug’s patent when generic versions of the medicine can be manufactured, and a strong brand can make physicians and patients want to stick with that brand, even when a cheaper generic is available.
Drug Name Achieved, What’s Next?
Choosing the right name can have a positive, significant, long-term effect on a drug’s commercial success. It is a critical step in building a brand, starting by establishing the medicine’s reputation for efficacy and safety and its place among therapeutic options for patients, and ultimately when entering the marketplace and reaching the patients for whom the medicine is intended. A marketing strategy supports this effort by educating formulary decision-makers, physicians, pharmacists and patients about this new option and building up the recognition and positive association with the brand. Over the course of the brand lifecycle, this strategy evolves to address new clinical and real-world data, the entry of competitors in the market, and ultimately the expiry of the patent when the competition balloons to include generic versions of the brand.
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