Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs. In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names. [1] Under the INN system, generic names for drugs are constructed out of affixes and stems that classify the drugs into useful categories while keeping related names distinguishable. [2] A marketed drug might also have a company code or compound code. [3]
Drug names are often subject to legal regulation, including approval for new drugs (to avoid confusion with existing drugs) and on packaging to establish clear rules about adulterants and fraudulent or misleading labeling. A national formulary [1] is often designated to define drug names (and purity standards) for regulatory purposes. The legally approved names in various countries include:
The World Health Organization administers the international nonproprietary name list.
A company or person developing a drug can apply for a generic (nonproprietary) name through their national formulary or directly to the WHO INN Programme. [4] In order to minimize confusion, many of the national naming bodies have policies of maintaining harmony between national nonproprietary names and INNs. [2] The European Union has mandated this harmonization for all member states [5] In the United States, the developer applies to United States Adopted Name (USAN) Council, and a USAN negotiator applies to the INN on the developer's behalf. [2]
The chemical names are the scientific names, based on the molecular structure of the drug. There are various systems of chemical nomenclature and thus various chemical names for any one substance. The most important is the IUPAC name. Chemical names are typically very long and too complex to be commonly used in referring to a drug in speech or in prose documents. [1] For example, "1-(isopropylamino)-3-(1-naphthyloxy) propan-2-ol" is a chemical name for propranolol. Sometimes, a company that is developing a drug might give the drug a company code, [3] which is used to identify the drug while it is in development. For example, CDP870 was UCB's company code for certolizumab pegol; UCB later chose "Cimzia" as its trade name. [1] Many of these codes, although not all, have prefixes that correspond to the company name.
Generic names are used for a variety of reasons. They provide a clear and unique identifier for active chemical substances, appearing on all drug labels, advertising, and other information about the substance. Relatedly, they help maintain clear differentiation between proprietary and nonproprietary aspects of reality, which people trying to sell proprietary things have an incentive to obfuscate; they help people compare apples to apples. They are used in scientific descriptions of the chemical, in discussions of the chemical in the scientific literature and descriptions of clinical trials. [2] Generic names usually indicate via their stems what drug class the drug belongs to. [6] For example, one can tell that aciclovir is an antiviral drug because its name ends in the -vir suffix.
The earliest roots of standardization of generic names for drugs began with city pharmacopoeias, such as the London, Edinburgh, Dublin, Hamburg, and Berlin Pharmacopoeias. The fundamental advances in chemistry during the 19th century made that era the first time in which what we now call chemical nomenclature, a huge profusion of names based on atoms, functional groups, and molecules, was necessary or conceivable. In the second half of the 19th century and the early 20th, city pharmacopoeias were unified into national pharmacopoeias (such as the British Pharmacopoeia, United States Pharmacopeia, Pharmacopoeia Germanica (PhG or PG), Italian Pharmacopeia, and Japanese Pharmacopoeia) and national formularies (such as the British National Formulary, the Australian Pharmaceutical Formulary, and the National Formulary of India). International pharmacopeias, such as the European Pharmacopoeia and the International Pharmacopoeia of the World Health Organization (WHO), have been the next level.
In 1953 the WHO created the International Nonproprietary Name (INN) system, which issues INNs in various languages, including Latin, English, French, Spanish, Russian, Chinese, and Arabic. Several countries also have national-level systems for creating generic drug names, including the British Approved Name (BAN) system, the Australian Approved Name (AAN) system, the United States Adopted Name (USAN) system (which is mostly the same as the United States Pharmacopeia (USP) system), and the Japanese Accepted Name (JAN) system. At least several of these national-level Approved Name/Adopted Name/Accepted Name systems were not created until the 1960s, after the INN system already existed. In the 21st century, increasing globalization is encouraging maximal rationalization for new generic names for drugs, and there is an increasing expectation that new USANs, BANs, and JANs will not differ from new INNs without special justification.
During the first half of the 20th century, generic names for drugs were often coined by contracting the chemical names into fewer syllables. Such contraction was partially, informally, locally standardized, but it was not universally consistent. In the second half of the 20th century, the nomenclatural systems moved away from such contraction toward the present system of stems and affixes that show chemical relationships.
Biopharmaceuticals have posed a challenge in nonproprietary naming because unlike smaller molecules made with total synthesis or semisynthesis, there is less assurance of complete fungibility between products from different manufacturers. Just as wine may vary by strain of yeast and year of grape harvest, so each product can be subtly different because living organisms are an integral part of production. The WHO MedNet community continually works to augment its system for biopharmaceuticals to ensure continued fulfillment of the goals served by having nonproprietary names. [7] In recent years the development of the Biological Qualifier system has been an example. [7]
The prefixes and interfixes have no pharmacological significance and are used to separate the drug from others in the same class. Suffixes or stems may be found in the middle or more often the end of the drug name, and normally suggest the action of the drug. Generic names often have suffixes that define what class the drug is. [2]
More comprehensive lists can be found in Appendix VII of the USP Dictionary or in the WHO INN stembook. [8]
If the name of the drug solanezumab were to be broken down, it would be divided into two parts like this: solane-zumab. -Zumab is the suffix for humanized monoclonal antibody. [10] Monoclonal antibodies by definition contain only a single antibody clone and have binding specificity for one particular epitope. [11] In the case of solanezumab, the antibody is designed to bond to the amyloid-β peptides which make up protein plaques on the neurons of people with Alzheimer's disease.
See also Time release technology > List of abbreviations for formulation suffixes.
For combination drug products—those with two or more drugs combined into a single dosage form—single nonproprietary names beginning with "co-" exist in both British Approved Name (BAN) form and in a formerly maintained USP name called the pharmacy equivalent name (PEN). Otherwise the two names are simply both given, joined by hyphens or slashes. For example, suspensions combining trimethoprim and sulfamethoxazole are called either trimethoprim/sulfamethoxazole or co-trimoxazole. Similarly, co-codamol is codeine-paracetamol (acetaminophen), and co-triamterzide is triamterene-hydrochlorothiazide. The USP ceased maintaining PENs, but the similar "co"-prefixed BANs are still current.
Most commonly, a nonproprietary drug name has one widely agreed pronunciation in each language. For example, doxorubicin is consistently /ˌdɒksoʊˈruːbɪsɪn/ in English. [12] [13] Trade names almost always have one accepted pronunciation, because the sponsoring company who coined the name has an intended pronunciation for it.
However, it is also common for a nonproprietary drug name to have two pronunciation variants, or sometimes three. For example, for paracetamol, both /ˌpærəˈsiːtəmɒl/ and /ˌpærəˈsɛtəmɒl/ [13] are common, and one medical dictionary gives /pæˌræsɪˈtæmɒl/ . [14]
Some of the variation comes from the fact that some stems and affixes have pronunciation variants. For example, the aforementioned third (and least common) pronunciation for paracetamol reflects the treatment of the acet affix as /ˈæsɪt/ rather than /əˈsiːt/ (both are accepted for acetyl [14] [12] ).
The World Health Organization does not give suggested pronunciations for its INNs, but familiarity with the typical sounds and spellings of the stems and affixes often points to the widely accepted pronunciation of any given INN. For example, abciximab is predictably /æbˈsɪksɪmæb/ , because for INNs ending in -ciximab , the /ˈsɪksɪmæb/ sound is familiar. The United States Pharmacopeia gives suggested pronunciations for most USANs in its USP Dictionary, which is published in annual editions. Medical dictionaries give pronunciations of many drugs that are both commonly used and have been commercially available for a decade or more, although many newer drugs or less common drugs are not entered. Pharmacists also have access to pronunciations from various clinical decision support systems such as Lexicomp.
For drugs that make it all the way through development, testing, and regulatory acceptance, the pharmaceutical company then gives the drug a trade name, which is a standard term in the pharmaceutical industry for a brand name or trademark name. For example, Lipitor is Pfizer's trade name for atorvastatin, a cholesterol-lowering medication. Many drugs have multiple trade names, reflecting marketing in different countries, manufacture by different companies, or both. Thus the trade names for atorvastatin include not only Lipitor (in the U.S.) but also Atocor (in India).
In the scientific literature, there is a set of strong conventions for drug nomenclature regarding the letter case and placement of nonproprietary and proprietary names, as follows:
For example, the 2015 American Society of Hematology (ASH) publication policies say, [15] "Non-proprietary (generic/scientific) names should be used and should be lowercase." [15] ... "[T]he first letter of the name of a proprietary drug should be capitalized." [15] ... "If necessary, you may include a proprietary name in parentheses directly following the generic name after its first mention." [15]
Valid exceptions to the general pattern occur when a nonproprietary name starts a sentence (and thus takes a capital), when a proprietary name has intercapping (for example, GoLYTELY, MiraLAX), or when tall-man letters are used within nonproprietary names to prevent confusion of similar names (for example, predniSONE versus predniSOLONE).
Chemical Name | Generic Name | Example Brand Name |
---|---|---|
N-acetyl-p-aminophenol | paracetamol, acetaminophen (US, JP) | Tylenol |
(RS)-2-(4-(2-methylpropyl)phenyl)propanoic acid | ibuprofen | Motrin |
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one | azithromycin | Zithromax |
ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene) -1-piperidinecarboxylate | loratadine | Claritin |
2-acetoxybenzoic acid | acetylsalicylic acid | Aspirin |
3-(2-methoxyphenoxy)propane-1,2-diol | guaifenesin | Mucinex |
2-(diphenylmethoxy)-N,N-dimethylethylamine hydrochloride | diphenhydramine | Benadryl |
3-[(4,5-dihydro-1H-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethyl-phenol hydrochloride | oxymetazoline | Visine |
(3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid | atorvastatin calcium | Lipitor |
4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5) | hydrocodone with acetaminophen | Vicodin |
A pharmacopoeia, pharmacopeia, or pharmacopoea, in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.
An international nonproprietary name (INN) is an official generic and nonproprietary name given to a pharmaceutical drug or an active ingredient. INNs are intended to make communication more precise by providing a unique standard name for each active ingredient, to avoid prescribing errors. The INN system has been coordinated by the World Health Organization (WHO) since 1953.
The United States Pharmacopeia (USP) is a pharmacopeia for the United States published annually by the over 200-year old United States Pharmacopeial Convention, a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself.
Radiopharmacology is radiochemistry applied to medicine and thus the pharmacology of radiopharmaceuticals. Radiopharmaceuticals are used in the field of nuclear medicine as radioactive tracers in medical imaging and in therapy for many diseases. Many radiopharmaceuticals use technetium-99m (Tc-99m) which has many useful properties as a gamma-emitting tracer nuclide. In the book Technetium a total of 31 different radiopharmaceuticals based on Tc-99m are listed for imaging and functional studies of the brain, myocardium, thyroid, lungs, liver, gallbladder, kidneys, skeleton, blood and tumors.
A British Approved Name (BAN) is the official, non-proprietary, or generic name given to a pharmaceutical substance, as defined in the British Pharmacopoeia (BP). The BAN is also the official name used in some countries around the world, because starting in 1953, proposed new names were evaluated by a panel of experts from WHO in conjunction with the BP commission to ensure naming consistency worldwide (an effort leading to the International Nonproprietary Name system). There is also a British Approved Name (Modified) (BANM).
A United States Adopted Name (USAN) is a unique nonproprietary name assigned to a medication marketed in the United States. Each name is assigned by the USAN Council, which is co-sponsored by the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA).
The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom. It is an annually published collection of quality standards for medicinal substances in the UK, which is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing.
The nomenclature of monoclonal antibodies is a naming scheme for assigning generic, or nonproprietary, names to monoclonal antibodies. An antibody is a protein that is produced in B cells and used by the immune system of humans and other vertebrate animals to identify a specific foreign object like a bacterium or a virus. Monoclonal antibodies are those that were produced in identical cells, often artificially, and so share the same target object. They have a wide range of applications including medical uses.
A formulary is a list of pharmaceutical drugs, often decided upon by a group of people, for various reasons such as insurance coverage or use at a medical facility. Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication. Today, the main function of a prescription formulary is to specify particular medications that are approved to be prescribed at a particular hospital, in a particular health system, or under a particular health insurance policy. The development of prescription formularies is based on evaluations of efficacy, safety, and cost-effectiveness of drugs.
A Japanese Accepted Name (JAN) is the official non-proprietary or generic name given to a pharmaceutical substance by the government of Japan.
Lifastuzumab vedotin is an experimental monoclonal antibody-drug conjugate designed for the treatment of cancer.
Sofituzumab vedotin is a monoclonal antibody designed for the treatment of ovarian cancer.
Ulocuplumab is a monoclonal antibody designed for the treatment of hematologic malignancies.
Seribantumab is a monoclonal antibody designed for the treatment of cancer. It binds to extracellular domain of HER3 blocking NRG1 binding and thereby preventing the activation of the receptor.
Brontictuzumab is a humanized monoclonal antibody designed for the treatment of cancer.
Denintuzumab mafodotin is a humanized monoclonal antibody-drug conjugate designed for the treatment of CD19-positive acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma. It consists of an anti-CD19 mAb linked to monomethyl auristatin F (MMAF), a cytotoxic agent. This drug was developed by Seattle Genetics.
Lumretuzumab is a humanized monoclonal antibody designed for the treatment of cancer.
Vanucizumab is an experimental humanized monoclonal antibody designed for the treatment of cancer.
Rosmantuzumab is a humanized monoclonal antibody designed for the treatment of cancer.
In chemistry, chemical purity is the measurement of the amount of impurities found in a sample. Several grades of purity are used by the scientific, pharmaceutical, and industrial communities. Some of the commonly used grades of purity include: