Naming guidelines for names adopted in the United States (2023)

By definition, common names are entirely in the public domain and not subject to trademark rights. A United States Adopted Name (USAN) is a common name chosen by the USAN Board to provide security, consistency, and logic in naming choices. These principles take into account the existence of trademarks, international harmonization of drug nomenclature, new classes of drugs and the fact that the intended uses of substances for which names are chosen may change.

• How does USAN work?(PDF)
• INN process in relation to the USAN process(PDF)
• How does USAN publish a name(PDF)

Unlike generic names, brand names vary from company to company and country to country. In rare cases, one brand can be used for 2 different active ingredients in different countries. More often, a company uses different brand names for the same drug in different countries, or two countries may market the same substance under different brand names. Finally, as part of "brand extension" business strategies, companies use the same brand name to refer to two different active ingredients.

Brand: CialisGeneric: Tadalafil

Trade name: Colemin, Lipex, Zocor and Vytorin Generic: Simvastatin

Marca: Gleevec, GlivecGenerika: Imatinibmesylat

1) A common name should be useful primarily to healthcare professionals, especially doctors, pharmacists, nurses, educators, dentists and veterinarians.

• The primary criterion for judging usefulness is suitability, including safety, for use in routine prescription, ordering, dispensing, and administration of medications in the United States.
• The second criterion is suitability for use in training programs for the medical professions and for use in scientific and non-professional publications.
• The third criterion is suitability for international use in drug identification, information exchange and translation into different languages.

2) Attributes that contribute to usefulness are simplicity (ie, brevity and ease of pronunciation), euphony, recognizability, and recall.

• The name of the active principle of a medicine must consist of a single word, preferably with a maximum of 4 syllables.
• The name of the active moiety may be modified with a single term, preferably no more than 4 syllables, to indicate a chemical modification such as salt or ester formation (eg cortisone acetate, cefamandole sodium or erythromycin acisrate).
• Only under demanding circumstances is a name with more than one modifier acceptable. Mandatory circumstances may include drugs that contain radioactive isotopes or the various classes of interferons.
• Acronyms, initials and abbreviated words may be acceptable in the appropriate terminology.

3) A name should reflect features and relationships that are of practical value to users.

• In the names of all members of a group of related drugs, a simple and common naming element (a "root") should be included where relevant common characteristics can be identified (eg similarity in pharmacological action). However, when pharmacological similarities are found in drugs of markedly different chemical nature, the strains must differ.
• Clear terminology should be used for specific drugs or groups (eg, insulin I 131, dextran 40, interferon alfa-2a and interferon alfa-n1; licryfilcon A and licryfilcon B; epoetin alfa and epoetin beta).

4) A name must not conflict with, mislead or be confused with other common names and established trademarks.

5) Prefixes derived from an obvious indication of a drug's indication, anatomy, or pharmacology, or that refer to a drug's quality, such as: B. long-lasting action, are not normally accepted by USANC. Also, some prefixes like pro-, dura-, neo-, etc. may be considered "promotional" and not accepted.

6) Names with established usage should be preferred as long as they comply with these guidelines and do not conflict with existing common names and trademarks.

7) Whenever possible, the USAN Board will assign substances to existing tribes or naming schemes that describe the substance, its effects or its use. A new strain will only be created in unusual circumstances when existing strains and naming schemes do not accurately represent a compound, its effect, structure or use, and also when substantial preclinical and clinical data support the creation of a new strain.

8) Identical deals submitted by 2 or more manufacturers will be conducted in accordance with the Council's confidentiality practices. Engaged applicants are not informed of multiple submission sources. However, the name chosen by the USAN Board must be accepted by each sponsor involved in the negotiation process.

9) A USAN application must be filed after the drug sponsor has filed aNew Drug Revision Request (IND).to the Food and Drug Administration for permission to begin human trials. An IND number is required before the USAN application review process can begin.

10) Trading may be suspended.

• The USAN Board Secretary will suspend an ongoing hearing for 6 months plus 1 additional 3 month extension upon receipt of a written request from the manufacturer. Once the USAN Board has selected a candidate name and recommended that name to the manufacturer, the maximum waiting period is 6 months.
• Trading will be closed after the end of the maximum holding period of 9 months.
• If the hearing needs to be resumed later, it will be treated as a new application and a new USAN case number will be assigned to it. The manufacturer is expected to submit a new USAN application form, update the basic information and submit the appropriate fee.

Feno USAN-Ratohas been inventing names since the early 1960s. The Code of Federal Regulations states that USAN is an established name for a drug. Learn more aboutUSAN-Rato.

USAN is provided for the following:

• small molecule drugs
• Biotechnological medicines, including monoclonal antibodies, therapeutic vaccines, proteins and peptides, DNA, RNA, nucleoside and nucleotide therapies
• gene therapies
• cell therapies
• Other biological substances considered eligible for USAN designation by the USAN Board
• contact lens materials
• Active ingredients of sunscreens
• veterinary products to combat animal diseases
• The base, salt, ester, or other chemical derivative of a substance that has received a USAN

USAN is not provided for the following:

• Mixtures that do not have an IND number or do not require FDA approval for human use
• bacterial strains
• Drug release mechanisms.
• excipients alone
• prophylactic vaccinations
• Product formulations* (emulsions, suspensions, etc.)
• Medical team
• manufacturing process
• combination drugs

*The USAN Board will not approve an exception to the above unless there is a clear and well-documented need, for example B. when the nomination promotes safety and furthers the USAN Board's nominating principles.

The number of names minted each year varies. In recent years, the USAN program has coined over 150 new names annually.

Several decades ago, when the USAN program began coining names (and even before its creation), condensing the systematic chemical name of a substance was a common method of coining drug names. This is not the case.

Now, new names consist of 3 parts: a prefix, an infix (sometimes) and a root.

Prefix: Doesn't mean anything; distinguishes the drug from others in the class

Infix: Used occasionally; more subdivisions

Stem: Indicates the location in the naming scheme; Drugs with the same strain are related

Roots usually appear at the end of a name, with a few exceptions (eg, cef-), and indicate the drug's place within the naming scheme. Consequently, a new suffix often, but not always, suggests a new mechanism of action. Drugs with the same suffix (strain) belong to the same drug family. Infixes appearing in the middle of the word are sometimes used to further classify the drug. The prefixes mean nothing. The sole purpose of a prefix is ​​to distinguish a drug from other members of the class.

As an example, consider sildenafil (Viagra™), vardenafil (Levitra™) and tadalafil (Cialis™). The -afil strain is formally defined as PDE5 (phosphodiesterase 5) inhibitors. The infix -den- indicates that sildenafil and vardenafil have similar chemical structures. The prefixes are sil-, var- and tadal-.

Following are brand names, generic names, and explanations of what the name means:

Strain: -statLipitor™ (atorvastatin calcium) Meaning: Enzyme Inhibitor

Tribe Crestor™ (rosuvastatin) subgroup: -vastatin Meaning: Inhibitors of HMG-CoA, an enzyme involved in the synthesis of cholesterol

Strain: -prazoleNexium™ (esomeprazole magnesium)Importance: Esomeprazole is a stereoisomer of omeprazole

Prevacid™ (lansoprazole) Meaning: agent for the treatment of ulcers and/or heartburn chemically related to benzimidazole

Strain: -lukastSingulair™ (Montelukast) Meaning: Antiallergic and antiasthmatic drugs that are leukotriene receptor antagonists

Strain: -grelPlavix™ (clopidogrel sulfate) Meaning: Antiplatelet agent

Strain: - FaxineEffexor XR™ (venlafaxine hydrochloride) Importance: anxiolytic, antidepressant, norepinephrine and dopamine reuptake inhibitor

Strain: -oxetineCymbalta™ (duloxetine hydrochloride) Meaning: Antidepressants with chemical structure related to fluoxetine

Strain: -sartanDiovan™ (valsartan) Meaning: Angiotensin II receptor antagonists

Strain: -oxacinLevaquin™ (Levofloxacin) Meaning: antibiotics that are chemical derivatives of quinolone

Strain: -virValtrex™ (Valaciclovir) Meaning: Antiviral Compounds Strain Subgroup: - Ciclovir Meaning: Chemical structure related to Aciclovir

Strain: -mabAvastin™ (bevacizumab) Meaning: Monoclonal Antibodies Strain Subgroup: -zumab Meaning: HumanizedInfix: -ci- for targets in the circulatory system (eg, inhibition of angiogenesis)

Remicade™ (Infliximab) Meaning: Monoclonal Antibodies Tribal Subgroup: -ximab Meaning: Chimera Infix: -li- for immune system targets

Prescription/sales information sources arewild pharmacy, Blue Cross/Blue Shield de Illinois epharmacy hours.

There are few prefixes and infixes with specific and defined meanings, some of which have been used to coin names of best selling drugs. Ar-, es-, lev- and dex- are used to name stereoisomers of drugs that have already received a USAN. For example, esomeprazole is a stereoisomer of omeprazole. Peg - means a biological substance, e.g. B. a peptide, is pegylated. -Io- was used as a suffix to indicate high levels of iodine (amiodarone). When -fos- occurs anywhere in the name of a drug, the element phosphorus is present, often as the phosphate ester.

Drugs with two-word names are usually salts, adducts with coprecipitated acidic molecules, esters, or prodrugs. The pharmacologically active part is usually listed first in a 2-word name. The second word designates the pharmacologically inactive part of the substance or the part of the ester or prodrug that is cleaved.Liveto generate the pharmacologically active species.

1) prefixes meaning "better", "newer" or "more effective"; Prefixes that evoke the name of the sponsor, pharmaceutical form, duration of action, or rate of drug release (eg, "hard", "strong" or "efex") should not be used.

2) Prefixes that refer to a Latin or Greek number are not acceptable unless they have a meaningful composition (eg "deci", "centi", "bi" or "di").

3) Prefixes with an anatomical connotation or reference to a medical condition are not accepted.

4) Prefixes denoting a chemical element or compound (Ca, Ni and Tin) are not acceptable.

5) Due to the international exchange of drug information, specific guidelines have been formulated to ensure proper translation of common names into other languages. These preferred phonetic spelling rules should be used:

• The letter "f" must be used instead of "ph".
• The letter "t" must be used instead of "th".
• The letter "e" must be used instead of "ae" or "oe".
• The letter "i" must be used instead of "y".
• Avoid the letter "h"
• Avoid the letter "k"
• Avoid the letter "j"
• Avoid the letter "w"
• "ar", "rac", "lev", "dex" or "es" are reserved for stereochemical configurations

6) Additionally, these letter combinations are restricted until further notice:

• Avoid the combination of the first letter "yo"
• Avoid the initial combination "str"
• Avoid chemical overtones such as ben, bu, cat, cel, fen, flu, fo(s) and pyro unless chemically appropriate
• Avoid chemical symbols unless they are in the compounds "al", "ba", "ca", "li" and "ni".
• Avoid starting with "z" or "x".
• Avoid mixtures of 2 consecutive vowels
• The letter q should be followed by a u to make it easier to pronounce.

7) Individual letters, numbers or hyphens are limited to groups of substances whose use serves a clearly demonstrable purpose (eg interferon alfa-2b, paflufocon A or technetium Tc 99m siboroxime).

8) Group relations in a name should preferably be indicated by the use of syllables or stems. Instead, the use of tribe for anyone other than the appropriate group should be avoided. If multiple strains are available, the strain with the most information should be used.

9) Esters, salts, chelates, prodrugs, and complexes generally require a two-word name to indicate the inactive and active moieties.

• The preferred order for naming an inorganic salt is cation-anion (eg, sodium chloride), regardless of the clinically significant ratio. The same order is preferred for well known salts of simple organic acids (eg sodium lactate, magnesium citrate, potassium acetate).
• For more complex organic compounds, the pharmacologically active fraction (eg, oxacillin sodium, dexibuprofen, lysine) must first be identified.
• The name of a salt or ester is usually derived from the name of the pharmacologically active moiety or the corresponding acid (eg, chloroprednisone acetate).
• Ester prodrugs that are cleavedLiveto release the pharmacologically active species are often given by two names (eg haloperidol decanoate, clindamycin palmitate). Other types of prodrugs may be given a 1- or 2-word name, notes the USAN Board.
• Exceptions to the 2-word names may be appropriate when differences in pharmacological activity to the ester form are clinically relevant (eg, when only the ester, but not the parent, is pharmacologically active). To receive a 1-word name for an ester, sponsors must submit data to document ester activity. The USAN Board may request such information if it is not provided.

10) As of January 2013, the name of the salt form of a pharmacologically active entity no longer indicates the number of molecules used to react with the active entity. Between January 1993 and December 2012, numerical prefixes were commonly used to indicate the number of molecules used to react with the active moiety (e.g. basal disodium azide).

11) A name for a quaternary ammonium substance should designate the cation and the anion separately (e.g. octonium bromideNomethyl octonine bromide). The name associated with the cation must contain-iosuffix root. This rule is modified when a second, more relevant root is used. In these cases, the addition of-ioa root suffix is ​​not required to uniquely designate a quaternary ammonium.

12) A name for a complex of 2 or more components should include the name of the primary active ingredient, followed by an elevated designation for the second component, ending with a suffix "-ex" to indicate "complex" (e.g. bisacodyl tannex , doxycycline). phosphate). Complexes formed from diethylbenzene-ethenylbenzene sulphonated copolymers and an active ingredient should indicate the name of the main active ingredient followed by "Polistirex", eg B. in chlorpheniraminepolitirexthe codeinepolitirex.

13) The name of a drug containing a radioactive atom must include in the order given: (1) the name of the drug containing the radioactive atom, (2) the symbol of the element, (3) the isotope number, and (4) ) the name of the carrier, if any (eg Rose Bengal Sodium I 131, Cyanocobalamin Co 60, Potassium Bromide Br 82, Technetium Tc 99m Butylphenine, Technetium Tc 99m Medronate, Indium 111 Oxyquinoline, Indium 111 satumomab pendetide).

14) In general, the name of a substance should not indicate the state of hydration, morphology or method of preparation. The reference to water of hydration remains in the chemical information (chemical names, formulas, weights), but is excluded from the free designation. The degree of hydration becomes part of the chemical entity identified by the USAN.

15) Under the terms of the Orphan Drugs Act 1983, the development and marketing of drugs with limited commercial application but potentially useful in relatively rare diseases is encouraged. Selection of a name for an orphan drug may be based on specific considerations. Therefore, if an orphan drug name appears to follow a more chemically oriented style of terminology than is normal for drug naming, this does not set a precedent for a future USAN.

16) A name coined for a new chemical entity usually does not indicate the stereoisomeric form of the molecule in the common name. Once the stereochemical configuration is determined, this information is presented in the chemical names and reflected in the structural formula. Thus, a USAN can identify the racemic mixture (eg, carnitine, ibuprofen, tetramisole), the levo isomer (eg, remoxipride, quadazocine), or the dextro form (eg, butopamine). If a name is later needed for another enantiomer or for the racemic form, the following prefixes must be added to the existing name:

• The prefix rac-/race- is used for the racemate (eg, racemethionine, racepinephrine, ractopamine).
• For the levorotatory form, the "(S)" isomer is used, the prefix lev/levo (eg, levocarnitine, levamisole, levcromakalim, and levdobutamine).
• For the levorotatory form, the "(R)" isomer, ["R(-)"] isomer, the prefix "ar-" is added to the base name.
• For the dextrorotatory form, the "(R)" isomer, the prefix dex-/dextro- is used (eg, dexamisole, dexibuprofen, dextroamphetamine, dexverapamil, dexrazoxane, dexphosphoserine, and dexniguldipine)
• For the dextrorotatory form, the "(S)" isomer ["S(+)" isomer], the prefix "es-" is added to the base name.

17) Official names were chosen for a series of radicals and adducts used to form salts or esters of the pharmacologically active fraction. In most cases, these names represent contractions of the chemical name assigned to the radical or adduct; in some cases, the official name identifies a multicomponent adduct.

Orphan Product Development Office