How to Apply for a Name
If a firm plans to market a therapeutic substance in the United States (US) and the USAN Council (USANC) names this type of therapy, a USAN should be requested. It is USAN policy that US pharmaceutical companies who intend to market their product(s) in the US, first apply for a nonproprietary name through their national nonproprietary naming commission, which in the US is the USAN Program. An International Nonproprietary Name (INN) is not a substitute for a USAN. In requesting a USAN, the sponsor gives permission to involve the INN Expert Group in creating a global name. After the USANC and the sponsor agree on a name, the USANC Secretariat submits it to the INN Expert Group for consideration, additional trademark clearance and linguistic evaluation. Because of the global nature of nonproprietary names and with so many pharmaceutical companies being multinational, a single designation used worldwide serving as the nonproprietary name in the US and in other countries is beneficial. If the name submitted to the USANC was previously approved by the INN Expert Group, indicate the WHO request number and/or proposed/recommended INN (pINN/rINN) list numbers on the USAN application. Firms that have an INN must apply for a USAN if they intend to use the name in the US.
What does the USAN Council name?
USAN will be provided for the following:
- small molecule drugs
- biotechnology drugs including monoclonal antibodies, therapeutic vaccines, proteins and peptides, DNA, RNA, nucleoside and nucleotide therapies
- gene therapies
- other biological substances deemed appropriate to be assigned a USAN by the USANC
- contact lens materials
- active ingredients in sunscreens
- veterinary products intended to control diseases in animals
- the base, salt, solvate, ester or other chemical derivative of a substance that has received a USAN
USAN will not be provided for:
- mixtures that do not have an IND number or do not require approval for human use by the FDA
- drug delivery mechanisms
- excipients alone
- prophylactic vaccines
- product formulations* (emulsions, suspensions, etc.)
- medical devices
- manufacturing processes
- combination drug products
*An exception to the above will only be authorized by the USANC if there is a clear and well documented need such that assignment of a name promotes safety and advances the USANC's nomenclature principles.
Because of changes in US salt nomenclature policies, firms are required to request a USAN for the active moiety (base, parent) of a compound and any salt form(s) that may be marketed when filing the initial USAN application. Please note that the USAN Program's definition of a salt includes counterions, coprecipitated solvent or acid molecules, and metal ion chelates. This is somewhat different than the usual chemical definition of a salt as a cation-anion pair. Esters also require a USAN and are usually carboxylic acid derivatives, but may have other forms, such as phosphate esters.
If a substance is regarded as an Investigational New Drug (IND) within the terms of the Federal Food, Drug and Cosmetic Act, selection of a USAN should begin during clinical trials, so that the USAN will be adopted before the relevant New Drug Application (NDA) is filed.
In practice, firms usually apply for a USAN when the investigational therapy is in Phase I or Phase II clinical trials. By then the sponsor's patents or intellectual property covering the substance are in place, and it is early enough in clinical trials that the risk of not having a name for the NDA is low.
Selecting an appropriate name to submit is a challenge. Overall, the Rules for Coining Names always apply, but there are additional, specific nomenclature rules for contact lens materials, gene therapies, immunotherapies, monoclonal antibodies and other biologics. In addition, new application requirements for biologics have been established. Please review these requirements and include with your application materials. Names should be coined, whenever possible, using the list of existing USAN stems and, for salts and esters, the list of names for organic radicals and anions. Before submitting an application also please take into consideration the following Chemical Abstracts Service (CAS) requirements and trademark screening.
A CAS number and name are required for all applications. This information is needed for adoption and publication. The FDA encourages use of this terminology for labeling purposes. Firms planning to market a salt or ester should supply a second CAS registry number and CA Index name for the parent substance. For contact lens materials and other synthetic polymers, CAS registry numbers should be supplied for each monomer and the entire polymer.
To obtain CAS registry numbers and CA index names, please contact CAS at the following:
By definition, USANs are in the public domain. Consequently, we ask sponsors to exercise responsibility and good judgment in developing trademarks for drug entities. A USAN, a stem or other parts of the name should not be incorporated into the trademark. Such tactics cause confusion in drug nomenclature, and the confusion created may compromise patient safety.
Incorporating a stem into a trade name interferes with nomenclature agencies' ability to systematically create new nonproprietary names for other members of a class of drugs. Therefore, the USANC Secretariat may lodge objections to proposed trademarks that conflict with USANs/INNs, or that incorporate common stems in trademarks.
More often, firms are conducting extensive trademark searches before applying for a USAN. At the time of submission, only a preliminary, potential conflict review on your suggested name is required. This typically entails an Internet search through a search engine such as Google or Yahoo, a search on MedNet and a search on the USAN Web site and USP database. Additional searches can include the United States Patent and Trademark Office and the Office for Harmonization in the Internal Market (Trademarks and Designs) which provides information regarding the European Community.
We do not require a lengthy, detailed, commisioned analysis or linguistic research activity of suggested names. If, however, you, as the applicant, choose to perform a detailed, commissioned analysis or linguistic report of the suggested name, it should be performed upon notification of the USAN Council's recommended name. Please keep in mind that the USAN Council could, and often does, recommend changes to the suggested names initially submitted by an applicant.
On the application form, firms list the desired name, provide necessary chemical information, explain and document the drug's indications and action, and supply information about the innovator company developing the therapy or drug.
The following items follow the USAN application and can be used as a reference in applying:
A. Suggested name
Applicants should propose one to three nonproprietary names for the substance. The suggested name for the active moiety of a drug should be a single word. If you already have an INN, please supply that name.
B. Chemical name or description
Usually two chemical names are listed for each substance. The first name listed in all USAN publications is that coined by CAS, the CA index name. The second name should be developed in accordance with nomenclature rules established by the International Union of Pure and Applied Chemistry (IUPAC). Because the IUPAC name is established by an independent chemical reviewer it may differ from those names the firm lists on the application. Occasionally the USAN Program will accept and list a third chemical name if a firm requests it.
In some cases, a description may identify a substance for which no CAS or IUPAC name can be assigned. This description may be superceded by the chemical name(s) after additional characterization.
In submitting a USAN application, the sponsor acknowledges that the USANC Secretariat will secure an IUPAC chemical name for the compound.
C. CAS registry number
A CAS number is required for all USAN submissions. The submitting firm must confirm that the CAS registry number and CA index name supplied are accurate and apply to the substance to be named. Sponsors naming a salt or ester should provide a second CAS registry number for the active parent species. The second CAS number is needed to forward nomenclature information to the INN Program.
Include proof of CAS information, provided as a copy of the firm's CAS correspondence or the results of a database search. In submitting the application form a firm grants the USAN Program permission to publish the chemical information.
D. Structural formula
A structural formula is necessary for the USANC to determine if a USAN or INN already exists. The structure is also needed to compare the drug to chemically related compounds. Chemical information should be as complete, current and accurate as possible, including information on stereochemistry, if known.
Specific rules and requirements apply to biologic substances. Applicants must show the complete and stereospecifically accurate structure for amino acid sequences containing less than ten amino acids. For all substances based on amino acids, the sequence must be supplied as an editable MS Word document, using a table format, and given using the one-letter codes in a series of ten with no more than 5 columns. In addition to adhering to the specific rules and requirements for biologics, please use the templates for monoclonal antibodies or other proteins when submitting sequences.
E. Molecular formula
A one-line molecular formula constructed in accordance with accepted chemical practices should be supplied, if possible. If the compound to be named is a salt or ester, the molecular formula information should be supplied for both the salt or ester and the compound from which it is derived. For salts, the active and other species should be listed separately, e.g., C8H13N5O4·HCl. If no molecular formula is available, such as for gene or cell therapies, this may be left blank.
F. Molecular weight
Molecular weight should be calculated in accordance with the most recent guidelines for standard atomic weights of the elements recommended by the IUPAC Commission on Atomic Weights and Isotopic Abundances. If no molecular weight can be calculated, this may be left blank, but approximate molecular weights should be listed if they are known.
G. Code designations
Any company code designation that has been assigned to the compound, particularly if this code has been used in published scientific papers, should be entered. The listed code designation must be specific for the chemical entity being developed. If the compound was licensed or acquired from another firm, former codes should be listed.
Any trademark issued for the drug should be provided. Any known foreign trademarks and the name of the country where the trademark is registered should be included.
I. Trivial names
Occasionally, long before a nonproprietary name or a trademark is created, a compound acquires a trivial name used in scientific journals. The USANC should be made aware of such names but requests that sponsors not create, use or encourage the creation of trivial names. The fact that a trivial name has become entrenched in the literature will NOT ensure its adoption as a USAN and may only cause confusion when one is adopted. In fact, many trivial names are not accepted because they do not conform to the USAN Program's IND application on file or select a new name without the IND number. Exceptions are made for drugs intended for veterinary use and contact lens polymers, which are usually not assigned IND numbers.
O. Where to send applications and payments
All application materials should be submitted to the USAN Program via email or an overnight delivery service.
Please send applications to the following:
American Medical Association
Attn: Stephanie C. Shubat, Director, USAN
515 N. State St.
Chicago, IL 60654
Please send payments to the following:
American Medical Association
515 N. State St.
Chicago, IL 60654
Please make sure to reference that the payment is for a USAN application and list the sponsor's code designation on the check.
Electronic credit card payments cannot be accepted, but electronic fund transfers are possible. Please contact Julie Murphy at (312) 464-4046 for more information.
After a firm submits a complete USAN application, negotiations proceed through a series of steps:
- Initial processing and review by USAN Program staff
- USANC recommends and sponsor accepts a name after balloting process is complete
- Consensus is reached with the WHO-INN Expert Group, if necessary
- The name is adopted and published with information that identifies the substance
Immediately after receiving a submission, the USAN Program Secretariat verifies that the application is complete (payment must be received) and that the substance meets all prerequisites to apply. Two important requirements are that the substance has entered clinical trials and has an IND number. If the requirements are met the submission is considered a complete application.
Each complete application is assigned a file number and a USAN staff member as the "negotiator." The negotiator serves as the manufacturer's contact for all questions and correspondence. Following assignment of these, the applicant receives an acknowledgment letter, which confirms receipt of the submission and application fee and includes the USAN file number and the name of the assigned negotiator.
Before submitting an application to the USANC, the negotiator verifies that all the information required for the USANC to select a name is included and prepares a summary for the USANC. To supplement what is provided by the applicant, the USANC may receive the results of literature and chemical searches, the results of a detailed check to verify the submitted names are free of conflicts, and analysis of the stem assignment requested by the applicant. Another important criterion for name selection is adherence to the current Rules for Coining Names, which are revised periodically as needed due to the constantly evolving nature of drug nomenclature.
All information included on the USAN application and provided by the applicant throughout the USAN negotiation process is kept confidential and is only shared with USAN Program staff, the USANC and the INN Expert Group.
Before most USANs are adopted, three parties (i.e., the sponsor, the USANC and the INN Expert Group) must accept the name. This process is facilitated by the USAN Program staff. All negotiations are conducted throughout the year by USANC member correspondence and electronic balloting or at either of the biannual USAN meetings, typically occuring in January/February and July. The purpose of these meetings is to review and set policy, review the INN Expert Group decisions, discuss multiple-round negotiations and address negotiations where a consensus has not yet been reached. New negotiations are accepted on a space-available basis.
When considering an acceptable name the following criteria are constantly kept in mind by the USANC: usefulness to healthcare providers, patient safety, adherence to the nomenclature rules, absence of conflicts with existing names, suitability for use internationally, ease of pronunciation, and other factors. The USANC does not choose names based on specific marketing considerations.
After the USANC completes deliberation and recommends a name it is sent to the sponsor for acceptance or rejection, the former leading to either the INN Expert Group review or USAN adoption (depending on what has been submitted), and the latter leading to a further round of balloting, which can add about six months to the timeline. The applicant should carefully weigh whether to reject the name and subsequently delay adoption. If the USANC deems a proposed name unacceptable due to conflicts or patient safety concerns, the name will not be reconsidered. If a new stem is deemed unacceptable, additional, new data and information are required to support the case for a new stem. New stems are assigned only when no existing stem is appropriate.
When accepting a name, the applicant will need to notify their assigned negotiator and, depending upon the type of submission, include a check made out to WHO for their application fee and to process the submission through the WHO-INN Expert Group to ultimately receive a recommended INN (rINN).
At this time, after the USANC recommendation letter is sent to the applicant, the recommended name is published on the USAN site as a name under consideration.
When rejecting a name, the notification should include new name suggestions for the USANC and explain the reasons for rejection. The USAN Program staff will review potential alternative suggestions before they are submitted to the USANC, as this will expedite further balloting. When an alternative is finalized the negotiator prepares a new ballot accompanied by the sponsor's letter describing reasons for rejecting the names and any new suppporting information. Additional rounds of USANC balloting are conducted as many times as necessary to reach an acceptable name. There is no charge for additional rounds of balloting.
At the completion of the USANC review and after a name is accepted, the USAN Program staff requests an INN on behalf of the sponsor (depending on the type of submission). Many firms seeking a USAN are multinational companies with subsidiaries outside the US. It is highly desirable to the drug firms, the various nomenclature committees and the medical community that a global name be established for each new substance. To prevent confusion with the use of multiple nonproprietary names in different counties, the WHO-INN Program coordinates drug nomenclature internationally. US drug sponsors should submit to the USANC first, but drug firms in countries where there are no national nomenclature agencies may apply directly to the INN Program.
Input from other countries is so valuable because it prevents selection of a USAN that could possibly have unnacceptable and unintended negative connotations in other languages. The INN Expert Group evaluates suggested names following procedures somewhat similar to those of the USAN Council, however, the deliberation and actual name selection occurs at each of their biannual meetings, not through a year-round balloting process. Also, there are some things, such as contact lens polymers and cell therapies, that are named by the USANC but not the INN Expert Group.
Following the INN review, and if all goes well with the proposed name, is the adoption of a USAN. Per standard USAN policy, adoptions occur the last Wednesday of each month. A letter and adoption statement formally notifies the applicant that the negotiation has been completed and a USAN assigned. A firm may begin using a USAN when it receives an adoption statement. There is no need to wait until publication, which would normally occur 60 days later. Upon publication the adoption statement is published on the USAN Web site and forwarded to both USP for inclusion in the USP Dictionary of USAN and International Drug Names and CAS for inclusion in their database. A firm may request a publication deferral for up to 6 months.
Not to be confused with the USAN Revised (USANR) application procedure, which will allow a firm to change supporting information of a USAN, but not the actual USAN.
The following procedures will allow a firm to actually change the USAN:
- The USAN Secretariat must be contacted with a written request for changing a USAN. Documentation must include official notice from pharmacovigilance systems, rationale, data and origin of request.
- The USAN Secretariat evaluates the request for merit and accuracy. Additional data may be requested of the petitioner.
- If the request is warranted, the USANC, sponsor, USP, FDA, Institute for Safe Medication Practices (ISMP) and American Pharmacists Association (APhA) are notified of the potential revision of the USAN in question.
- The USAN Secretariat prepares the background and alternative names relevant to the request. It is then discussed at either of the two biannual USANC meetings.
- The USANC reviews the request and renders a decision. In the event the USANC concludes that there are no compelling reasons to revise or substitute a previously adopted USAN, the name shall be retained.
- The drug sponsor, USP, FDA, ISMP, APhA (as well as the INN Program) are notified of the USANC's decision if the USAN has been changed.
- Once a consensus is reached among the USANC, USP and FDA, the information is posted on the USAN Web site, allowing time for public comment.
- If the USAN has been formally changed official notification is made by the sponsor, FDA, ISMP and USP.
Reasons for changing a USAN:
- Official notification from pharmacovigilance system of medication errors involving the USAN in question.
- Proven previous trademark infringement with the USAN in question.
- Any other nomenclature issue deemed relevant by the USAN Secretariat.