What’s in a name? An overview of the drug naming process
Introduction
In the U.S., drugs have three types of names: chemical, generic, and brand. Here’s how each is determined.
Chemical name
A drug’s chemical name describes its atomic or molecular structure using guidelines from the International Union of Pure and Applied Chemistry (IUPAC). These names tend to be complex and difficult to pronounce, so a shorthand version is often used.
Example:
The chemical name of Xanax® is 8-chloro-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine.
Generic name
The United States Adopted Names (USAN) Council assigns a drug’s generic name. This name provides insight into the drug’s structure, function, or intended use.
Key Components of a Generic Name:
- Prefix: A short segment distinguishing the drug from others.
- Stem: A suffix that indicates chemical structure, function, or classification.
- Substem (if applicable): Further refines classification.
Generic names must be easy to pronounce and cannot contain the letters H, K, J, W, or Y.
Example:
Alprazolam, lorazepam, and clonazepam are all in the same drug class, benzodiazepines.
Brand name
A brand name is developed after the chemical and generic names are established. Pharmaceutical companies often work with branding agencies to create names that are:
- Easy to pronounce across different languages.
- Memorable and simple (typically four syllables or fewer).
- Unique to prevent confusion with other drugs.
FDA guidelines
The FDA has strict rules for brand names. They must not:
- Sound/look too similar to other drug names.
- Contain medical claims.
- Resemble the generic name.
- Promote the manufacturer.
Each company can submit only one brand name for FDA approval.
Read more
- International Union of Pure and Applied Chemistry (IUPAC)
- United States Adopted Names (USAN) Council
- 2024 drug approvals, breakthroughs, and trends
- The current state of U.S. drug shortages
- Drug Pipeline Report Q1 2025
References
- Smith Marsh, Daphne E. Overview of Generic Drugs and Drug Naming. Merck Manual Consumer Version. April 2023: https://www.merckmanuals.com/home/drugs/brand-name-and-generic-drugs/overview-of-generic-drugs-and-drug-naming
- Alprazolam. Compound Summary. National Library of Medicine. National Center for Biotechnology Information. PubChem.
- Steensma, David. What’s in a (Drug) Name? ASH Clinical News. May 2018: https://ashpublications.org/ashclinicalnews/news/3808/What-s-in-a-Drug-Name
- USAN Council. American Medical Association. December 18, 2024: https://www.ama-assn.org/about/united-states-adopted-names/usan-council#:~:text=any%20additional%20questions.-,About%20the%20USAN%20Council,American%20Pharmacists%20Association%20(APhA)
- Karet, Gail B. How Do Drugs Get Named? History of Medicine. August 2019: https://journalofethics.ama-assn.org/article/how-do-drugs-get-named/2019-08#:~:text=Since%20the%201960s%2C%20the%20United,international%20regulators)%20must%20be%20balanced.
- How Do Medicines Get Their Names? Cleveland Clinic. December 4, 2024: https://health.clevelandclinic.org/how-are-medicines-named
- Sohal, Mandeep. How Are Drugs Named? A Deep Dive on Drug Nomenclature and Pronunciation. GoodRx. February 21, 2023: https://www.goodrx.com/drugs/medication-basics/how-are-drugs-named
- Best Practices in Developing Proprietary Names for Human Prescription Drug Products. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research. December 2020: https://www.fda.gov/media/88496/download
- Winny, Annalies. Why Do Prescription Drugs Have Such Crazy Names? Global Health Now. Johns Hopkins Bloomberg School of Public Health. July 9, 2024: https://globalhealthnow.org/2024-07/why-do-prescription-drugs-have-such-crazy-names
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