Developing a nonproprietary name is an important milestone in a pharmaceutical product’s development. It is also a process shaped by scientific naming conventions, regulatory requirements, agency timing, and decisions that may affect both United States Adopted Names (USAN) and International Nonproprietary Names (INN).

For pharmaceutical and biotech teams planning activity in 2027, early preparation is especially important. The World Health Organization (WHO) considers new INN requests during consultations held twice each year, while the USAN Council accepts applications electronically on an ongoing basis.

The questions below address some of the considerations sponsors should understand as they prepare for USAN and INN name development and submission.

What is the difference between a USAN and an INN?

A United States Adopted Name is the nonproprietary name assigned through the USAN Council for use in the United States. An International Nonproprietary Name is selected through the WHO INN Programme and is intended to provide a single, globally recognized name for a pharmaceutical substance or active pharmaceutical ingredient.

Although the two systems work toward closely related goals, their processes, timing, and application requirements differ. Sponsors developing products for multiple markets should consider both pathways as part of one coordinated naming strategy.

Does the USAN Council meet only twice a year?

Yes. The USAN Council holds formal meetings twice annually; however, application review and balloting continue throughout the year. Sponsors may submit applications on an ongoing basis.

This gives sponsors more flexibility in determining when to submit a USAN application. However, the overall timeline must still allow for application review, correspondence, potential name negotiation, coordination with INN, and other development milestones.

Should a sponsor pursue USAN or INN first?

The appropriate sequence depends on factors such as the sponsor’s location, target markets, development timeline, and broader regulatory strategy.

For a United States pharmaceutical company intending to market its product in the United States, USAN Program policy is to apply through USAN first. Once the sponsor and the USAN Council agree on a proposed name, USAN Program staff submit an INN application to WHO on the sponsor’s behalf. International sponsors may pursue either USAN or INN first, depending on their target markets and development strategy.

This decision should be made early because the selected sequence affects the project timeline, application planning, and how the team prepares for correspondence from each organization.

When should nonproprietary name development begin?

There is no single starting point that applies to every asset. In general, sponsors should begin early enough to allow time for scientific and naming-scheme analysis, candidate development, name evaluation, prioritization, application preparation, internal review, agency review, and potential backup-name development.

Waiting until an application deadline is approaching can place unnecessary pressure on name development and evaluation. Early INN submission planning gives the team more time to resolve questions about stems, naming schemes, candidate conflicts, and submission sequencing.

What should sponsors know about the 2027 INN calendar?

As of August 28, 2026, WHO had not yet published the official dates or submission windows for its 2027 INN consultations. These dates should not be estimated and presented as confirmed deadlines.

The most recent confirmed consultation is the 83rd INN Consultation, scheduled for October 12–15, 2026. For that consultation, WHO began limiting the final month’s intake on June 13, 2026, accepting only the first 30 complete new requests. The available-request counter subsequently reached zero.

This reinforces an important planning lesson for 2027: the published deadline may not be the only date that matters. Sponsors should prepare to submit well before the final intake period.

Preliminary 2027 USAN and INN Planning Calendar

Planning note: All anticipated 2027 dates and consultation numbers should be confirmed against current WHO guidance before publication or submission

Also planning a European proprietary name? The European Medicines Agency Name Review Group (NRG) follows a separate schedule from USAN and INN activity. Sponsors coordinating nonproprietary and proprietary naming should account for both timelines in their broader development plan. Review the official 2026-2027 NRG meeting dates and submission deadlines.

Why is early submission important for INN applications?

WHO has taken steps to manage the concentration of new INN requests submitted close to consultation deadlines. For the October 2026 consultation, only the first 30 complete new requests submitted during the final intake period were accepted.

A sponsor that waits until the published deadline may therefore find that the consultation has already reached capacity. Preparing early can also provide more time to identify missing information and resolve questions before the request is submitted.

How many USAN application forms are there?

The USAN Program currently uses six application forms, with the correct form determined by the type of substance or request: Form A for a single entity drug and salt form; Form B for a single entity; Form C for a modified compound; Form D for a revision to an established USAN; Form E for contact lens material; and Form F for biologics.

Applications and payments must be submitted electronically through the USAN Application Portal. Fees vary by form, and sponsors should confirm current amounts directly with the American Medical Association before submission.

The USAN Program also introduced a revised adoption-statement policy effective February 1, 2026. Firms may request one round of revisions to an adoption statement without an additional fee. Further revisions, or revisions requested more than 60 days after adoption, require a revised submission and associated fee.

Can a sponsor explore more than one naming scheme?

Yes. Some compounds may reasonably support more than one possible naming scheme.

Exploring the alternatives can help demonstrate that the sponsor has evaluated the scientific and regulatory considerations behind the proposed approach. The application strategy should then explain which naming scheme is considered most appropriate and why.

This analysis can become particularly important for novel compounds that do not fit clearly within an existing stem or established class, as illustrated in BrandSymbol’s reproxalap nonproprietary naming case study.

What makes a strong nonproprietary name candidate?

A viable candidate must do more than follow a recognizable construction pattern. It should be scientifically appropriate, consistent with applicable naming guidance, and sufficiently differentiated from relevant names and terminology.

Evaluation may include alignment with the appropriate stem or naming scheme; review against existing and proposed nonproprietary names; consideration of potentially confusing proprietary names; trademark screening; linguistic and cultural review; pronunciation and word-part analysis; and documentation of the scientific rationale.

The goal is to give decision-makers a clear basis for prioritizing candidates before they are included in an application.

Are conflict checks required for proposed USAN candidates?

Conflict review is an important part of evaluating proposed nonproprietary names. Potential conflicts are not limited to existing USAN or INN names. Depending on the candidate, relevant considerations may also include proprietary names, chemical terminology, homeopathic products, and other names that could create confusion.

A broader evaluation can help a sponsor understand candidate risk before names are prioritized for submission.

Why consider trademark and linguistic review for a nonproprietary name?

Although a nonproprietary name is not owned like a trademark, trademark screening may identify relevant conflicts that would not appear in a review limited to existing nonproprietary names.

Linguistic review can also identify pronunciation concerns, unintended meanings, associations, or interpretations created by individual word parts. These findings can be valuable when a name will be used across multiple countries and languages.

Together, these reviews provide a more complete picture of each candidate before a sponsor commits to a preferred submission order.

When should a sponsor involve a nonproprietary naming partner?

Outside support can be useful when a team needs help determining whether to pursue USAN or INN first, building a realistic development and submission timeline, identifying the appropriate naming scheme, developing candidates, evaluating potential conflicts, prioritizing candidates, preparing application materials, or responding to agency questions. BrandSymbol’s 10 Steps to Nonproprietary Naming webinar series provides additional perspective on these stages.

Bringing the right expertise into the process early can help the sponsor coordinate scientific, regulatory, linguistic, and naming considerations before they become submission-stage issues.

Planning a USAN or INN submission in 2027?

BrandSymbol’s nonproprietary naming team helps pharmaceutical and biotech companies develop, evaluate, prioritize, and prepare nonproprietary name candidates for USAN and INN submission.

If your team is beginning to plan for 2027, connect with BrandSymbol’s Regulatory Division to discuss your asset, timing, and submission strategy.

Speak with a nonproprietary naming expert