Each year, the World Health Organization (WHO) opens the window for submitting new International Non-proprietary Name (INN) requests. If your drug candidate is approaching the stage where it requires a generic name, it’s important to plan ahead as the process can be more complex than many teams expect.

Once the annual countdown begins, the timeline moves quickly. Missing the submission window can delay your naming strategy and potentially impact downstream regulatory and branding milestones.

Key Timeline to Watch

While dates can shift slightly each year, the general cadence remains consistent:

• Mid-December: The official INN submission countdown begins
• Mid-January: Deadline for submitting new INN name requests

Because the submission window is short, sponsors should begin preparing well in advance. This includes evaluating potential stems, ensuring compliance with linguistic and safety guidelines, and coordinating with other naming bodies.

Common Questions About the INN Process

Teams preparing for submission often ask:

Q: How many names can be submitted in an INN request?
A: WHO INN permits up to six names per submission.

Q: Should we apply to the United States Adopted Names Council (USAN) or INN first?
A: This is strategy-dependent: USAN operates on a rolling review basis, permits multiple candidates, and will submit to INN upon selection, whereas INN follows fixed consultation cycles (typically biannual) and does not initiate USAN submission.

Q: What happens if there is an opportunity for a new stem?
A: Potential new stems must be identified early and supported by a robust scientific and pharmacologic rationale, necessitating expert development and justification for evaluation by naming authorities.

Q: How do INN rules impact brand name strategy later on?
A: INN conventions establish stems and similarity thresholds that proprietary names must avoid, requiring deliberate differentiation to meet regulatory expectations and mitigate rejection risk.

Navigating these considerations early can help avoid delays and ensure alignment between generic naming, regulatory expectations, and future brand development.

Start Planning Early

The INN process is a critical milestone in drug development. Starting early gives your team time to explore compliant name options, anticipate potential objections, and coordinate your global naming strategy.

If you’re preparing for an upcoming INN submission and have questions about the process, timelines, or strategy, our team can help guide you through it. Click here to see our webinar series: 10 Steps to Nonproprietary Naming.

Click here for an application and a manual.